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A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)

Primary Purpose

Acute Bacterial Skin and Skin Structure Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tedizolid phosphate
Comparator
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bacterial Skin and Skin Structure Infections

Eligibility Criteria

undefined - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a parent/legally acceptable representative who is able to give documented informed consent
  • Has ABSSSI, defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection
  • Local symptoms of ABSSSI that started within 14 days before study start
  • Suspected or documented Gram-positive bacterial infection
  • Body weight ≥3.2 kg

Exclusion Criteria:

  • Uncomplicated skin and skin structure infection
  • ABSSSI due to or associated with disallowed etiology per protocol
  • Received antibacterial therapy for treatment of the current episode of ABSSSI except 1) <48 hours of antibacterial therapy with a short-acting antibacterial drug, or 2) response is considered to be failure (no improvement in signs and symptoms) after at least 48 hours of therapy
  • Known bacteremia, severe sepsis, or septic shock
  • Significant or life-threatening condition, disease, or organ system condition
  • Recent history of opportunistic infections where the underlying cause of the infection is still active, or is suspected to be at risk of opportunistic infection with unusual pathogens
  • Received or is receiving treatment for active tuberculosis within 1 month of study start
  • Known or suspected severe neutropenia
  • Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4 cell count <15% (HIV testing is not required for eligibility)
  • Renal impairment that requires renal filtration
  • Severe hepatic impairment
  • Cardiac or electrocardiogram (ECG) finding that would limit participation in the study
  • Received an investigational medicinal product (not approved) within 30 days before study start
  • Investigational device present or removed within 30 days before study start
  • Previously treated with tedizolid phosphate
  • Contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation
  • Contraindication, including hypersensitivity to all available comparator drugs
  • Wound infection and history of hypersensitivity to aztreonam adjunctive therapy or metronidazole adjunctive therapy, if adjunctive therapy is required
  • Needs oral administration of methotrexate, topotecan, irinotecan, or rosuvastatin, during administration of oral study drug (administration during the follow-up period, ie, after the EOT visit, is allowed, as is administration during treatment with IV drug)
  • Female who is pregnant or nursing or is of childbearing potential and not abstinent; or male who is not abstinent
  • Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors, or serotonin 5-hydroxytryptamine receptor agonists (triptans)
  • Identified as having used illicit drugs (urine drug screening not required for entry)

Sites / Locations

  • Rady Children's Hospital-San Diego ( Site 0118)
  • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129)
  • Children's Hospital of Michigan ( Site 0100)
  • William Beaumont Hospital ( Site 0108)
  • St. Louis Children's Hospital ( Site 0127)
  • Cook Children's Medical Center ( Site 0124)
  • Baylor College of Medicine - Texas Children's Hospital ( Site 0107)
  • Children's Hospital of Richmond at VCU ( Site 0123)
  • Hospital Pequeno Principe ( Site 0276)
  • Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277)
  • Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCL-CENTRO DE ESTUDOS E PESQUISAS EM MOLES
  • Instituto D'Or de Pesquisa e Ensino (IDOR)-Hospital São Luiz Jabaquara ( Site 0283)
  • MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338)
  • UMHAT Deva Maria ( Site 0333)
  • MHAT City Clinic Sv. Georgi EOOD ( Site 0334)
  • MHAT Dr. Stamen Iliev AD ( Site 0339)
  • UMHAT Dr. Georgi Stranski EAD ( Site 0330)
  • UMHAT Sv. Georgi ( Site 0332)
  • MBAL Medica Ruse EOOD ( Site 0336)
  • UMHAT Kanev AD ( Site 0337)
  • UMHATEM. N.I.Pirogov. EAD ( Site 0331)
  • JSC Evex Hospitals. ( Site 0601)
  • Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic ( Site 0600)
  • JSC Evex Hospital ( Site 0602)
  • JSC Evex Hospitals ( Site 0603)
  • Haunersches Kinderspital ( Site 0480)
  • Clinica Privada ( Site 0551)
  • Private Practice Mario Melgar ( Site 0552)
  • Private Practice Dra. Manrique ( Site 0553)
  • Daugavpils Regional Hospital ( Site 0651)
  • Liepaja Regional Hospital ( Site 0652)
  • Hospital of Lithuanian University of Health Sciences Kaunas ( Site 0701)
  • Klaipedos Vaiku Ligonine ( Site 0700)
  • Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0702)
  • Instituto Nacional de Pediatria ( Site 0231)
  • Hospital Infantil de Mexico Federico Gomez ( Site 0227)
  • Hospital Civil Fray Antonio Alcalde-pediatrics infectious diseases ( Site 0230)
  • CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 0241)
  • Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0239)
  • Wojewodzki Szpital Obserwacyjno Zakazny ( Site 0429)
  • Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 0427)
  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0431)
  • City Childrens Clinical Emergency Hospital ( Site 0507)
  • Smolensk Regional Clinical Hospital ( Site 0511)
  • Children s Republican Clinical Hospital ( Site 0512)
  • Emmed Research Incorporating ( Site 0377)
  • Setshaba Research Centre ( Site 0378)
  • Enhancing Care Foundation-DICRS ( Site 0381)
  • Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0353)
  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0351)
  • Ankara City Hospital-Infectious Disease and Clinical Microbiology ( Site 0359)
  • Osmangazi UTF ( Site 0357)
  • Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0355)
  • Sisli Hamide Etfal Egitim ve Arastirma Hastanesi ( Site 0358)
  • Ege UTF ( Site 0356)
  • Dnipropetrovsk Oblast Children's Clinical Hospital ( Site 0868)
  • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0863)
  • Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0865)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Cohort 1: Tedizolid phosphate 6 to <12 Years

Cohort 1 Comparator: 6 to <12 Years

Cohort 2: Tedizolid phosphate 2 to <6 Years

Cohort 2 Comparator: 2 to <6 Years

Cohort 3: Tedizolid phosphate 28 Days to <2 Years

Cohort 3: Comparator: 28 Days to <2 Years

Cohort 4: Tedizolid phosphate Birth to <28 Days Neonates

Comparator: Birth to <28 Days (Term and preterm neonates)

Arm Description

Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days

Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days

Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.

Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days

Participants will receive tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose is to be determined based on results of another study covering the age range.

Participants will receive comparator IV and/or oral per local standard of care for 10 to14 days

Outcomes

Primary Outcome Measures

Percentage of participants with ≥1 adverse events (AEs)
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants with one or more AEs will be reported.
Percentage of participants discontinuing from study therapy due to AEs
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants discontinued from the study due to an AE will be reported.
Percentage of participants with hematopoietic cytopenias
A standardized MedDRA query for hematopoietic cytopenia will be conducted. The percentage of participants with a hematopoietic cytopenia will be reported.

Secondary Outcome Measures

Percentage of participants with clinical success
The investigator's assessment of clinical response will be conducted at the Test of Cure (TOC) visit, approximately 25 days after the first infusion. Clinical success is defined as 1) resolution or near-resolution of most signs and symptoms, 2) absence or near-resolution of signs of infection, and 3) no new signs, symptoms, or complications attributable to the infections (no further antibiotic therapy required for the primary lesion). The percentage of participants with clinical success will be reported.

Full Information

First Posted
June 1, 2017
Last Updated
July 13, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03176134
Brief Title
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
Official Title
A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
July 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).
Detailed Description
Participants will be randomized (3:1) to receive tedizolid phosphate at a weight-based dose ≤200 mg/day, intravenous (IV) and/or oral suspension for 6 to 10 days, or comparator IV and/or oral per local standard of care for 10 to 14 days. The switch from IV to oral administration can be made at any time based on 1) no worsening of the primary skin lesion, 2) last temperature <37.7 °C, and 3) primary acute bacterial skin and skin structure infection (ABSSSI) site has not worsened and at least 1 site has improved from Baseline. The potential 4-day treatment extension will be based on clinical need as judged by the investigator, considering the following criteria: 1) ≥40% reduction in primary lesion size, 2) reduction in pain, and 3) no new signs and symptoms and no complications attributable to ABSSSI compared with Baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Skin and Skin Structure Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Tedizolid phosphate 6 to <12 Years
Arm Type
Experimental
Arm Description
Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
Arm Title
Cohort 1 Comparator: 6 to <12 Years
Arm Type
Active Comparator
Arm Description
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Arm Title
Cohort 2: Tedizolid phosphate 2 to <6 Years
Arm Type
Experimental
Arm Description
Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
Arm Title
Cohort 2 Comparator: 2 to <6 Years
Arm Type
Active Comparator
Arm Description
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Arm Title
Cohort 3: Tedizolid phosphate 28 Days to <2 Years
Arm Type
Experimental
Arm Description
Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
Arm Title
Cohort 3: Comparator: 28 Days to <2 Years
Arm Type
Active Comparator
Arm Description
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Arm Title
Cohort 4: Tedizolid phosphate Birth to <28 Days Neonates
Arm Type
Experimental
Arm Description
Participants will receive tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose is to be determined based on results of another study covering the age range.
Arm Title
Comparator: Birth to <28 Days (Term and preterm neonates)
Arm Type
Active Comparator
Arm Description
Participants will receive comparator IV and/or oral per local standard of care for 10 to14 days
Intervention Type
Drug
Intervention Name(s)
Tedizolid phosphate
Other Intervention Name(s)
MK-1986, TR-701 FA
Intervention Description
Tedizolid phosphate IV solution or oral suspension
Intervention Type
Drug
Intervention Name(s)
Comparator
Intervention Description
Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the trial site and administered per local standard of care
Primary Outcome Measure Information:
Title
Percentage of participants with ≥1 adverse events (AEs)
Description
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants with one or more AEs will be reported.
Time Frame
Up to Day 35
Title
Percentage of participants discontinuing from study therapy due to AEs
Description
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants discontinued from the study due to an AE will be reported.
Time Frame
Up to Day 35
Title
Percentage of participants with hematopoietic cytopenias
Description
A standardized MedDRA query for hematopoietic cytopenia will be conducted. The percentage of participants with a hematopoietic cytopenia will be reported.
Time Frame
Up to Day 35
Secondary Outcome Measure Information:
Title
Percentage of participants with clinical success
Description
The investigator's assessment of clinical response will be conducted at the Test of Cure (TOC) visit, approximately 25 days after the first infusion. Clinical success is defined as 1) resolution or near-resolution of most signs and symptoms, 2) absence or near-resolution of signs of infection, and 3) no new signs, symptoms, or complications attributable to the infections (no further antibiotic therapy required for the primary lesion). The percentage of participants with clinical success will be reported.
Time Frame
Day 25

10. Eligibility

Sex
All
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a parent/legally acceptable representative who is able to give documented informed consent Has ABSSSI, defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection Local symptoms of ABSSSI that started within 14 days before study start Suspected or documented Gram-positive bacterial infection Body weight ≥3.2 kg Exclusion Criteria: Uncomplicated skin and skin structure infection ABSSSI due to or associated with disallowed etiology per protocol Received antibacterial therapy for treatment of the current episode of ABSSSI except 1) <48 hours of antibacterial therapy with a short-acting antibacterial drug, or 2) response is considered to be failure (no improvement in signs and symptoms) after at least 48 hours of therapy Known bacteremia, severe sepsis, or septic shock Significant or life-threatening condition, disease, or organ system condition Recent history of opportunistic infections where the underlying cause of the infection is still active, or is suspected to be at risk of opportunistic infection with unusual pathogens Received or is receiving treatment for active tuberculosis within 1 month of study start Known or suspected severe neutropenia Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4 cell count <15% (HIV testing is not required for eligibility) Renal impairment that requires renal filtration Severe hepatic impairment Cardiac or electrocardiogram (ECG) finding that would limit participation in the study Received an investigational medicinal product (not approved) within 30 days before study start Investigational device present or removed within 30 days before study start Previously treated with tedizolid phosphate Contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation Contraindication, including hypersensitivity to all available comparator drugs Wound infection and history of hypersensitivity to aztreonam adjunctive therapy or metronidazole adjunctive therapy, if adjunctive therapy is required Needs oral administration of methotrexate, topotecan, irinotecan, or rosuvastatin, during administration of oral study drug (administration during the follow-up period, ie, after the EOT visit, is allowed, as is administration during treatment with IV drug) Female who is pregnant or nursing or is of childbearing potential and not abstinent; or male who is not abstinent Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors, or serotonin 5-hydroxytryptamine receptor agonists (triptans) Identified as having used illicit drugs (urine drug screening not required for entry)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Rady Children's Hospital-San Diego ( Site 0118)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Children's Hospital of Michigan ( Site 0100)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
William Beaumont Hospital ( Site 0108)
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
St. Louis Children's Hospital ( Site 0127)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cook Children's Medical Center ( Site 0124)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine - Texas Children's Hospital ( Site 0107)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hospital of Richmond at VCU ( Site 0123)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Hospital Pequeno Principe ( Site 0276)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277)
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-902
Country
Brazil
Facility Name
Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCL-CENTRO DE ESTUDOS E PESQUISAS EM MOLES
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59025-050
Country
Brazil
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)-Hospital São Luiz Jabaquara ( Site 0283)
City
Sao Paulo
ZIP/Postal Code
04321-120
Country
Brazil
Facility Name
MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338)
City
Lom
State/Province
Montana
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
UMHAT Deva Maria ( Site 0333)
City
Burgas
ZIP/Postal Code
8127
Country
Bulgaria
Facility Name
MHAT City Clinic Sv. Georgi EOOD ( Site 0334)
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
MHAT Dr. Stamen Iliev AD ( Site 0339)
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
UMHAT Dr. Georgi Stranski EAD ( Site 0330)
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Sv. Georgi ( Site 0332)
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MBAL Medica Ruse EOOD ( Site 0336)
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
UMHAT Kanev AD ( Site 0337)
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
UMHATEM. N.I.Pirogov. EAD ( Site 0331)
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
JSC Evex Hospitals. ( Site 0601)
City
Batumi
State/Province
Ajaria
ZIP/Postal Code
6010
Country
Georgia
Facility Name
Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic ( Site 0600)
City
Tiblisi
State/Province
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
JSC Evex Hospital ( Site 0602)
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
JSC Evex Hospitals ( Site 0603)
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Haunersches Kinderspital ( Site 0480)
City
München
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Clinica Privada ( Site 0551)
City
Guatemala
ZIP/Postal Code
01001
Country
Guatemala
Facility Name
Private Practice Mario Melgar ( Site 0552)
City
Guatemala
ZIP/Postal Code
01009
Country
Guatemala
Facility Name
Private Practice Dra. Manrique ( Site 0553)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Daugavpils Regional Hospital ( Site 0651)
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Liepaja Regional Hospital ( Site 0652)
City
Liepaja
ZIP/Postal Code
3414
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas ( Site 0701)
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Klaipedos Vaiku Ligonine ( Site 0700)
City
Klaipeda
ZIP/Postal Code
92140
Country
Lithuania
Facility Name
Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0702)
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Instituto Nacional de Pediatria ( Site 0231)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Hospital Infantil de Mexico Federico Gomez ( Site 0227)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Hospital Civil Fray Antonio Alcalde-pediatrics infectious diseases ( Site 0230)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 0241)
City
Gral Escobedo
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0239)
City
Aguascalientes
ZIP/Postal Code
20259
Country
Mexico
Facility Name
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 0429)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 0427)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-347
Country
Poland
Facility Name
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0431)
City
Lomianki
State/Province
Mazowieckie
ZIP/Postal Code
05-092
Country
Poland
Facility Name
City Childrens Clinical Emergency Hospital ( Site 0507)
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Smolensk Regional Clinical Hospital ( Site 0511)
City
Smolensk
State/Province
Smolenskaya Oblast
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Children s Republican Clinical Hospital ( Site 0512)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420138
Country
Russian Federation
Facility Name
Emmed Research Incorporating ( Site 0377)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Setshaba Research Centre ( Site 0378)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0152
Country
South Africa
Facility Name
Enhancing Care Foundation-DICRS ( Site 0381)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4013
Country
South Africa
Facility Name
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0353)
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0351)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ankara City Hospital-Infectious Disease and Clinical Microbiology ( Site 0359)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Osmangazi UTF ( Site 0357)
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0355)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Sisli Hamide Etfal Egitim ve Arastirma Hastanesi ( Site 0358)
City
Istanbul
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Ege UTF ( Site 0356)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Dnipropetrovsk Oblast Children's Clinical Hospital ( Site 0868)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0863)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0865)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76014
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)

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