search
Back to results

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

Primary Purpose

Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dalbavancin single dose
Dalbavancin two dose
Comparator
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methicillin-Resistant Staphylococcus Aureus focused on measuring Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Eligibility Criteria

0 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients birth to 17 years (inclusive)
  • A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA).
  • In addition to local signs of ABSSSI, the patient has at least one of the following:
  • Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR
  • Leukocytosis (WBC > 10,000 mm3) or leukopenia (WBC < 2,000 mm3) or left shift of >10% band neutrophils
  • Infection either involving deeper soft tissue or requiring significant surgical intervention
  • Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration

    • In patients age birth to < 3 months, each patient must meet the following inclusion criteria to be enrolled in this study.

      1. Male or female patients from birth to < 3 months of age, including pre-term neonates (gestational age ≥ 32 weeks)
      2. A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA.

        OR

        Suspected or confirmed sepsis including any of the following clinical criteria:

        1. Hypothermia (<36°C) OR fever (>38.5°C)
        2. Bradycardia OR tachycardia OR rhythm instability
        3. Hypotension OR mottled skin OR impaired peripheral perfusion
        4. Petechial rash
        5. New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support
        6. Feeding intolerance OR poor sucking OR abdominal distension
        7. Irritability
        8. Lethargy
        9. Hypotonia
      3. In addition, patients must meet at least one of the following laboratory criteria:

        a. White blood cell count ≤4.0 × 10^9/L OR ≥20.0 × 10^9/L b, Immature to total neutrophil ratio >0.2 c. Platelet count ≤100 × 10^9/L d. C-reactive protein (CRP) >15 mg/L OR procalcitonin ≥ 2 ng/mL e. Hyperglycemia OR Hypoglycemia f. Metabolic acidosis

      4. Infections must be of sufficient severity to merit hospitalization and parenteral antibiotic therapy. These infections may include:

        1. Cutaneous or subcutaneous abscess
        2. Surgical site or traumatic wound infection
        3. Cellulitis, Erysipelas
        4. Omphalitis
        5. Impetigo and bullous impetigo
        6. Pustular folliculitis
        7. Scarlet fever
        8. Staphylococcal scalded skin syndrome
        9. Streptococcal toxic shock syndrome
        10. Erythematous based-erosion
        11. Other infections originating in the skin or subcutaneous tissue and associated with signs and symptoms of sepsis as defined in Inclusion Criterion 2.
      5. Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study.

Exclusion Criteria:

  1. Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz "bedside" formula). Patients birth to < 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output < 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis.
  2. Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age.
  3. Treatment with an investigational drug within 30 days preceding the first dose of study medication.
  4. Patients with sustained shock defined as systolic blood pressure < 90 mm Hg in children ≥ 10 years old, < 70 mm Hg + [2 x age in years] in children 1 to <10 years, or < 70 mmHg in infants 3 to <12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
  5. More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms.
  6. Infection due to an organism known prior to study entry to be resistant to dalbavancin (dalbavancin minimum inhibitory concentration (MIC) greater than 0.25 ug/mL) or vancomycin (vancomycin minimum inhibitory concentration (MIC) greater than 2 ug/mL).
  7. Patients with necrotizing fasciitis, or deep-seated infections that would require > 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).
  8. Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
  9. Venous catheter entry site infection.
  10. Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
  11. Patient with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, implantable pacemaker or defibrillator, intraaortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
  12. Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia.
  13. Patients whose skin infection is the result of having sustained full or partial thickness burns.
  14. Patients age 3 months to 17 years, with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. Patients birth to < 3 months of age may be enrolled if they have uncomplicated skin infections of sufficient severity to require hospitalization and parenteral antibiotic therapy.
  15. Patients age 3 months to 17 years: Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
  16. Sickle cell anemia
  17. Cystic fibrosis
  18. Anticipated need of antibiotic therapy for longer than 14 days.
  19. Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
  20. More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 such interventions.
  21. Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
  22. Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count < 500 cells/mm3, receiving immunosuppressant drugs after organ transplantation, receiving oral steroids ≥ 20 mg prednisolone per day (or equivalent) for > 14 days prior to enrollment, and known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count< 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.
  23. Known or suspected hypersensitivity to glycopeptide antibiotics, betalactam agents, aztreonam, or cephalosporins.
  24. Patients with a rapidly fatal illness, who are not expected to survive for 3 months.
  25. Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing).
  26. Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use adequate contraceptive precautions. Female patients to have pregnancy testing are those who are at least 10 years old with menarche and/or thelarche (beginning of breast development).

Sites / Locations

  • University of South Alabama /ID# 237446
  • Southbay Pharma Research /ID# 235700
  • University of California, Los Angeles /ID# 237533Recruiting
  • Children's Hospital Colorado /ID# 237622
  • Tampa General Hospital /ID# 237061Recruiting
  • Children's Healthcare of Atlanta - Ferry Rd /ID# 237003
  • University of Maryland Medical Center /ID# 234353
  • Children's Mercy Hospital and Clinics /ID# 237800Recruiting
  • Robert Wood Johnson Univ Hosp /ID# 237862
  • SUNY Upstate Medical University /ID# 236831
  • Duke University Medical Center /ID# 234315Recruiting
  • Cleveland Clinic Main Campus /ID# 237564
  • Multiprofile Hospital for Active Treatment ( UMHAT) Sveti Georgi EAD Plovdiv /ID# 235487Recruiting
  • UMHAT Sveti Georgi /ID# 237026Recruiting
  • UMHAT Kanev /ID# 237809
  • SHAT Hematologic Diseases /ID# 237915Recruiting
  • Hospital de Ninos Dr. Roberto del Rio /ID# 235568
  • Fundacion Cardioinfantil /Id# 238041
  • Hospital Universitario San Vic /ID# 238117
  • LTD Unimedi Kakheti Children New Hospital /ID# 235634
  • Papageorgiou General Hospital Thessaloniki /ID# 237505
  • General Hospital of Thessaloniki Hippokrateio /ID# 237186Recruiting
  • Hospital Roosevelt /ID# 235520Recruiting
  • Hospital del Centro Medico Infectology Department /ID# 235522
  • Instituto Nacional de Pediatria /ID# 235506
  • Hospital Materno Infantil José Domingo de Obaldía /ID# 235625
  • Hospital Del Niño Dr. José Renán Esquivel /ID# 235572
  • Hospital Universitario y Politecnico La Fe /ID# 237086Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Dalbavancin, single dose

Dalbavancin, two doses

Comparator

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with abnormal audiologic assessment
Audiologic testing will be conducted in at least 20 children < 12 years old, of which at least 9 children will be < 2 years old. Audiologic testing to be conducted on infants (< 12 months old) will include: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing will include evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Patients with an abnormal audiologic assessment at Day 28 (plus or minus 2 days) that exceeds, by a clinically significant margin, any abnormality observed in the Baseline assessment, will be considered to have an abnormal audiologic assessment
Change in number of patients with the presence of either Clostridium difficile (CD), vancomycin-resistant enterococci (VRE), or both CD and VRE in bowel flora
Evaluated in patients from birth to < 2 years of age, by performing polymerase chain reaction (PCR) for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab.

Secondary Outcome Measures

Clinical response
Defined as greater than 20% reduction in lesion size compared to baseline. In patients diagnosed with ABSSSI age birth to < 3 months, clinical response at 48-72 hours post-randomization is defined as cessation of increase in lesion size and decreased erythema or tenderness compared to baseline with no appearance of new lesions. In patients diagnosed with sepsis age birth to < 3 months, clinical response at 48-72 hours post-randomization is defined as improvement of at least one abnormal clinical and laboratory parameter related to sepsis.
Clinical response evaluated at the end of treatment (EOT) visit: Cure
Clinical response of Cure will be defined as resolution of the clinical signs and symptoms of infection, when compared to baseline. No additional antibacterial treatment is required for disease under study.
Clinical response evaluated at the end of treatment (EOT) visit: Improvement
Clinical response of Improvement will be defined as a reduction in severity of two or more, but not all, clinical signs and symptoms of infection, when compared with baseline (patients age 3 months to 17 years and ABSSSI patients age birth to <3 months). In sepsis patients age birth to < 3 months, improvement is defined as reduction in severity of at least one abnormal clinical and laboratory parameter related to sepsis, when compared with baseline. In patients age 3 months to 17 years, no additional antibacterial treatment is required for disease under study. In patients age birth to < 3 months, no rescue antibiotics required after at least 48 hours of start of study treatment. This outcome category will only be used at the EOT evaluation.
Clinical response evaluated at the end of treatment (EOT) visit: Failure
Clinical response of Failure will be defined as persistence or progression of baseline clinical signs and symptoms of infection after at least 2 days (48 hours) of treatment OR development of new clinical findings consistent with active infection.
Clinical response evaluated at the end of treatment (EOT) visit: Unknown
Clinical response of Unknown will be defined as extenuating circumstances precluding classification to Cure, Improvement or Failure
Clinical response evaluated at the test of cure (TOC) visit: Cure
Clinical response of Cure will be defined as resolution of the clinical signs and symptoms of infection, when compared to baseline. No additional antibacterial treatment is required for disease under study.
Clinical response evaluated at the test of cure (TOC) visit: Failure
Clinical response of Failure will be defined as persistence or progression of baseline clinical signs and symptoms of infection after at least 2 days (48 hours) of treatment OR development of new clinical findings consistent with active infection.
Clinical response evaluated at the test of cure (TOC) visit: Unknown
Clinical response of Unknown will be defined as extenuating circumstances precluding classification to Cure or Failure
Clinical response evaluated at follow-up visit: Cure
Clinical response of Cure will be defined as resolution of the clinical signs and symptoms of infection, when compared to baseline. No additional antibacterial treatment is required for disease under study.
Clinical response evaluated at follow-up visit: Failure
Clinical response of Failure will be defined as persistence or progression of baseline clinical signs and symptoms of infection after at least 2 days (48 hours) of treatment OR development of new clinical findings consistent with active infection.
Clinical response evaluated at follow-up visit: Unknown
Clinical response of Unknown will be defined as extenuating circumstances precluding classification to Cure or Failure
Presence of baseline pathogen after treatment
Direct demonstration of eradication or persistence of the causative organism
All-cause mortality: For patients age birth to < 3 months, all-cause mortality will be determined at test of cure (TOC) visit
Dalbavancin plasma concentration

Full Information

First Posted
June 8, 2016
Last Updated
July 3, 2023
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT02814916
Brief Title
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
Official Title
A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
November 28, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
Keywords
Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dalbavancin, single dose
Arm Type
Experimental
Arm Title
Dalbavancin, two doses
Arm Type
Experimental
Arm Title
Comparator
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dalbavancin single dose
Intervention Description
Dalbavancin, weight-adjusted dose, up to 1500mg. Intravenous (IV) administration. Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used. Patients age birth to <3 months will only receive the single-dose regimen of dalbavancin; any concomitant antibacterial therapy may be administered in this age group based on local standard of care.
Intervention Type
Drug
Intervention Name(s)
Dalbavancin two dose
Intervention Description
Dalbavancin, weight-adjusted dose, up to 1000mg. Intravenous (IV) administration, with second dalbavancin weight-adjusted dose, up to 500mg. Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used.
Intervention Type
Drug
Intervention Name(s)
Comparator
Intervention Description
Course of either vancomycin not to exceed a total daily dose of 4000 mg;or oxacillin; or flucloxacillin not to exceed a total daily dose of 2000 mg. Intravenous (IV) administration. Possible oral switch after at least 72 hours from oxacillin or flucloxacillin to oral cefadroxil, or from IV vancomycin to oral clindamycin (for MRSA). Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used. Additional comparator drugs may be used, if an alternate comparator regimen is indicated by local susceptibility patterns. No patient age birth to < 3 months will be randomized to the comparator arm.
Primary Outcome Measure Information:
Title
Number of patients with abnormal audiologic assessment
Description
Audiologic testing will be conducted in at least 20 children < 12 years old, of which at least 9 children will be < 2 years old. Audiologic testing to be conducted on infants (< 12 months old) will include: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing will include evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Patients with an abnormal audiologic assessment at Day 28 (plus or minus 2 days) that exceeds, by a clinically significant margin, any abnormality observed in the Baseline assessment, will be considered to have an abnormal audiologic assessment
Time Frame
Baseline to Day 28 (± 2 days)]
Title
Change in number of patients with the presence of either Clostridium difficile (CD), vancomycin-resistant enterococci (VRE), or both CD and VRE in bowel flora
Description
Evaluated in patients from birth to < 2 years of age, by performing polymerase chain reaction (PCR) for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab.
Time Frame
Baseline to Day 28 (± 2 days)
Secondary Outcome Measure Information:
Title
Clinical response
Description
Defined as greater than 20% reduction in lesion size compared to baseline. In patients diagnosed with ABSSSI age birth to < 3 months, clinical response at 48-72 hours post-randomization is defined as cessation of increase in lesion size and decreased erythema or tenderness compared to baseline with no appearance of new lesions. In patients diagnosed with sepsis age birth to < 3 months, clinical response at 48-72 hours post-randomization is defined as improvement of at least one abnormal clinical and laboratory parameter related to sepsis.
Time Frame
Baseline to 48 - 72 hours
Title
Clinical response evaluated at the end of treatment (EOT) visit: Cure
Description
Clinical response of Cure will be defined as resolution of the clinical signs and symptoms of infection, when compared to baseline. No additional antibacterial treatment is required for disease under study.
Time Frame
Baseline and Day 14 (± 2 Days)
Title
Clinical response evaluated at the end of treatment (EOT) visit: Improvement
Description
Clinical response of Improvement will be defined as a reduction in severity of two or more, but not all, clinical signs and symptoms of infection, when compared with baseline (patients age 3 months to 17 years and ABSSSI patients age birth to <3 months). In sepsis patients age birth to < 3 months, improvement is defined as reduction in severity of at least one abnormal clinical and laboratory parameter related to sepsis, when compared with baseline. In patients age 3 months to 17 years, no additional antibacterial treatment is required for disease under study. In patients age birth to < 3 months, no rescue antibiotics required after at least 48 hours of start of study treatment. This outcome category will only be used at the EOT evaluation.
Time Frame
Baseline and Day 14 (± 2 Days)
Title
Clinical response evaluated at the end of treatment (EOT) visit: Failure
Description
Clinical response of Failure will be defined as persistence or progression of baseline clinical signs and symptoms of infection after at least 2 days (48 hours) of treatment OR development of new clinical findings consistent with active infection.
Time Frame
Baseline and Day 14 (± 2 Days)
Title
Clinical response evaluated at the end of treatment (EOT) visit: Unknown
Description
Clinical response of Unknown will be defined as extenuating circumstances precluding classification to Cure, Improvement or Failure
Time Frame
Baseline and Day 14 (± 2 Days)
Title
Clinical response evaluated at the test of cure (TOC) visit: Cure
Description
Clinical response of Cure will be defined as resolution of the clinical signs and symptoms of infection, when compared to baseline. No additional antibacterial treatment is required for disease under study.
Time Frame
Baseline and Day 28 (± 2 Days)
Title
Clinical response evaluated at the test of cure (TOC) visit: Failure
Description
Clinical response of Failure will be defined as persistence or progression of baseline clinical signs and symptoms of infection after at least 2 days (48 hours) of treatment OR development of new clinical findings consistent with active infection.
Time Frame
Baseline and Day 28 (± 2 Days)
Title
Clinical response evaluated at the test of cure (TOC) visit: Unknown
Description
Clinical response of Unknown will be defined as extenuating circumstances precluding classification to Cure or Failure
Time Frame
Baseline and Day 28 (± 2 Days)
Title
Clinical response evaluated at follow-up visit: Cure
Description
Clinical response of Cure will be defined as resolution of the clinical signs and symptoms of infection, when compared to baseline. No additional antibacterial treatment is required for disease under study.
Time Frame
Baseline and Day 54 (± 7 days)
Title
Clinical response evaluated at follow-up visit: Failure
Description
Clinical response of Failure will be defined as persistence or progression of baseline clinical signs and symptoms of infection after at least 2 days (48 hours) of treatment OR development of new clinical findings consistent with active infection.
Time Frame
Baseline and Day 54 (± 7 days)
Title
Clinical response evaluated at follow-up visit: Unknown
Description
Clinical response of Unknown will be defined as extenuating circumstances precluding classification to Cure or Failure
Time Frame
Baseline and Day 54 (± 7 days)
Title
Presence of baseline pathogen after treatment
Description
Direct demonstration of eradication or persistence of the causative organism
Time Frame
Baseline to Day 54 (± 7 days)
Title
All-cause mortality: For patients age birth to < 3 months, all-cause mortality will be determined at test of cure (TOC) visit
Time Frame
Baseline and Day 28 (± 2 days)
Title
Dalbavancin plasma concentration
Time Frame
Within 14 (± 2) days of study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients birth to 17 years (inclusive) A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA). In addition to local signs of ABSSSI, the patient has at least one of the following: Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR Leukocytosis (WBC > 10,000 mm3) or leukopenia (WBC < 2,000 mm3) or left shift of >10% band neutrophils Infection either involving deeper soft tissue or requiring significant surgical intervention Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration In patients age birth to < 3 months, each patient must meet the following inclusion criteria to be enrolled in this study. Male or female patients from birth to < 3 months of age, including pre-term neonates (gestational age ≥ 32 weeks) A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA. OR Suspected or confirmed sepsis including any of the following clinical criteria: Hypothermia (<36°C) OR fever (>38.5°C) Bradycardia OR tachycardia OR rhythm instability Hypotension OR mottled skin OR impaired peripheral perfusion Petechial rash New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support Feeding intolerance OR poor sucking OR abdominal distension Irritability Lethargy Hypotonia In addition, patients must meet at least one of the following laboratory criteria: a. White blood cell count ≤4.0 × 10^9/L OR ≥20.0 × 10^9/L b, Immature to total neutrophil ratio >0.2 c. Platelet count ≤100 × 10^9/L d. C-reactive protein (CRP) >15 mg/L OR procalcitonin ≥ 2 ng/mL e. Hyperglycemia OR Hypoglycemia f. Metabolic acidosis Infections must be of sufficient severity to merit hospitalization and parenteral antibiotic therapy. These infections may include: Cutaneous or subcutaneous abscess Surgical site or traumatic wound infection Cellulitis, Erysipelas Omphalitis Impetigo and bullous impetigo Pustular folliculitis Scarlet fever Staphylococcal scalded skin syndrome Streptococcal toxic shock syndrome Erythematous based-erosion Other infections originating in the skin or subcutaneous tissue and associated with signs and symptoms of sepsis as defined in Inclusion Criterion 2. Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study. Exclusion Criteria: Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz "bedside" formula). Patients birth to < 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output < 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis. Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age. Treatment with an investigational drug within 30 days preceding the first dose of study medication. Patients with sustained shock defined as systolic blood pressure < 90 mm Hg in children ≥ 10 years old, < 70 mm Hg + [2 x age in years] in children 1 to <10 years, or < 70 mmHg in infants 3 to <12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure. More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms. Infection due to an organism known prior to study entry to be resistant to dalbavancin (dalbavancin minimum inhibitory concentration (MIC) greater than 0.25 ug/mL) or vancomycin (vancomycin minimum inhibitory concentration (MIC) greater than 2 ug/mL). Patients with necrotizing fasciitis, or deep-seated infections that would require > 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis). Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen. Venous catheter entry site infection. Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer. Patient with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, implantable pacemaker or defibrillator, intraaortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter. Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia. Patients whose skin infection is the result of having sustained full or partial thickness burns. Patients age 3 months to 17 years, with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. Patients birth to < 3 months of age may be enrolled if they have uncomplicated skin infections of sufficient severity to require hospitalization and parenteral antibiotic therapy. Patients age 3 months to 17 years: Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study. Sickle cell anemia Cystic fibrosis Anticipated need of antibiotic therapy for longer than 14 days. Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI. More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 such interventions. Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity). Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count < 500 cells/mm3, receiving immunosuppressant drugs after organ transplantation, receiving oral steroids ≥ 20 mg prednisolone per day (or equivalent) for > 14 days prior to enrollment, and known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count< 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count. Known or suspected hypersensitivity to glycopeptide antibiotics, betalactam agents, aztreonam, or cephalosporins. Patients with a rapidly fatal illness, who are not expected to survive for 3 months. Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing). Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use adequate contraceptive precautions. Female patients to have pregnancy testing are those who are at least 10 years old with menarche and/or thelarche (beginning of breast development).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama /ID# 237446
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-3302
Country
United States
Individual Site Status
Completed
Facility Name
Southbay Pharma Research /ID# 235700
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Individual Site Status
Completed
Facility Name
University of California, Los Angeles /ID# 237533
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Children's Hospital Colorado /ID# 237622
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
Tampa General Hospital /ID# 237061
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Healthcare of Atlanta - Ferry Rd /ID# 237003
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1605
Country
United States
Individual Site Status
Completed
Facility Name
University of Maryland Medical Center /ID# 234353
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Individual Site Status
Completed
Facility Name
Children's Mercy Hospital and Clinics /ID# 237800
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Robert Wood Johnson Univ Hosp /ID# 237862
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Completed
Facility Name
SUNY Upstate Medical University /ID# 236831
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Completed
Facility Name
Duke University Medical Center /ID# 234315
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-4410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Cleveland Clinic Main Campus /ID# 237564
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Completed
Facility Name
Multiprofile Hospital for Active Treatment ( UMHAT) Sveti Georgi EAD Plovdiv /ID# 235487
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Sveti Georgi /ID# 237026
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Kanev /ID# 237809
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Completed
Facility Name
SHAT Hematologic Diseases /ID# 237915
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Hospital de Ninos Dr. Roberto del Rio /ID# 235568
City
Independencia
ZIP/Postal Code
8380418
Country
Chile
Individual Site Status
Completed
Facility Name
Fundacion Cardioinfantil /Id# 238041
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
111156
Country
Colombia
Individual Site Status
Completed
Facility Name
Hospital Universitario San Vic /ID# 238117
City
Medellin
ZIP/Postal Code
50010
Country
Colombia
Individual Site Status
Completed
Facility Name
LTD Unimedi Kakheti Children New Hospital /ID# 235634
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Individual Site Status
Completed
Facility Name
Papageorgiou General Hospital Thessaloniki /ID# 237505
City
Stavroupoli (Thessalonikis)
State/Province
Thessaloniki
ZIP/Postal Code
55536
Country
Greece
Individual Site Status
Completed
Facility Name
General Hospital of Thessaloniki Hippokrateio /ID# 237186
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hospital Roosevelt /ID# 235520
City
Guatemala
ZIP/Postal Code
1011
Country
Guatemala
Individual Site Status
Recruiting
Facility Name
Hospital del Centro Medico Infectology Department /ID# 235522
City
Guatemala
ZIP/Postal Code
1016
Country
Guatemala
Individual Site Status
Completed
Facility Name
Instituto Nacional de Pediatria /ID# 235506
City
Coyoacan
State/Province
Ciudad De Mexico
ZIP/Postal Code
04530
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Hospital Materno Infantil José Domingo de Obaldía /ID# 235625
City
Chiriquí
State/Province
Chiriqui
Country
Panama
Individual Site Status
Completed
Facility Name
Hospital Del Niño Dr. José Renán Esquivel /ID# 235572
City
Panama City
ZIP/Postal Code
0816-00383
Country
Panama
Individual Site Status
Completed
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 237086
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related info

Learn more about this trial

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

We'll reach out to this number within 24 hrs