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Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection (MOXIPEDIA)

Primary Purpose

Intraabdominal Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Moxifloxacin (Avelox, BAY12-8039)
Ertapenem
Amoxicillin/Clavulanate
Moxifloxacin placebo
Ertapenem placebo
Amoxicillin/Clavulanate placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraabdominal Infections focused on measuring Intra-abdominal infection, Pediatric infection

Eligibility Criteria

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

Inclusion Criteria:

  • Hospitalized males or females 3 months to 17 years of age
  • Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations
  • Expected duration of treatment with antibiotics is a minimum of 3 days administered IV, for a total of 5 to 14 days administered IV or IV followed by PO
  • If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit or be capable of practicing an adequate method of contraception, and agree to continue the same method for 1 month following the TOC visit. Lactating subjects are not to be included.

  • Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous drainage) confirmed cIAI revealing at least one of the following:

    • Gross peritoneal inflammation with purulent exudate within the abdominal cavity
    • Intra-abdominal abscess
    • Macroscopic intestinal perforation with diffuse peritonitis OR

  • Subjects may be enrolled on the basis of a suspected cIAI, which must be supported with radiological evidence (ultrasound, abdominal plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of gastrointestinal perforation or localized collections of potentially infected material and at least one of the following:

    • Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain)
    • Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
    • Fever
    • Leukocytosis
  • The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage.

Exclusion Criteria:

  • Presumed spontaneous bacterial peritonitis
  • All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis
  • Early acute or suppurative (nonperforated) appendicitis unless there is evidence of an abscess or peritoneal fluid containing pus and micro-organisms suggestive of regional contamination
  • Infections originating from the female genital tract
  • Known severe immunosuppression. Subjects with known mild immunosuppression (eg, Type I or II diabetes mellitus, trauma, or absolute neutrophil count [ANC] between 1000 and 1500 cells/mm3) may be enrolled.
  • Congenital or documented acquired QT prolongation
  • Receiving concomitant treatment with QT prolonging drugs
  • History of tendon disease/disorder related to quinolone treatment
  • Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs
  • Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)
  • History of myasthenia gravis

Sites / Locations

  • Hospital de Agudos "Dr. Carlos Bocalandro"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxifloxacin (Avelox, BAY12-8039)

Comparator Ertapenem

Arm Description

Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.

Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Subjects With Clinical Cardiac Adverse Events
Number of Subjects With Musculoskeletal Adverse Events

Secondary Outcome Measures

Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term
Musculoskeletal adverse events were classified as following SOCs (preferred terms): "injury, poisoning and procedural complications" (forearm fracture, joint injury, ligament sprain, muscle strain) "musculoskeletal and connective tissue disorders" (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms.
Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
"N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
The RR interval refers to the respective time interval in the Electrocardiogram. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3
The QRS interval represents the time it takes for ventricular depolarization to occur. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3
A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3
A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.
Clinical Response at Test-of-Cure (TOC) Visit
Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.
Bacteriological Response at Test-of-Cure (TOC) Visit
Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate. 'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported.
Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)
Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported
Clinical Response at a 'During Therapy' Visit
Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy. 'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported.
Bacteriological Response at a 'During Therapy' Visit
Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported
Clinical Response at the End-of-Treatment (EOT) Visit
Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.
Bacteriological Response at the End of Treatment (EOT) Visit
Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.

Full Information

First Posted
February 15, 2010
Last Updated
February 22, 2018
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01069900
Brief Title
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
Acronym
MOXIPEDIA
Official Title
A Randomized, Double-blind, Multicenter Trial to Evaluate the Safety and Efficacy of Sequential (Intravenous, Oral) Moxifloxacin Versus Comparator in Pediatric Subjects With Complicated Intra-abdominal Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 21, 2010 (Actual)
Primary Completion Date
January 21, 2015 (Actual)
Study Completion Date
January 21, 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to <18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraabdominal Infections
Keywords
Intra-abdominal infection, Pediatric infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
458 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moxifloxacin (Avelox, BAY12-8039)
Arm Type
Experimental
Arm Description
Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.
Arm Title
Comparator Ertapenem
Arm Type
Active Comparator
Arm Description
Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin (Avelox, BAY12-8039)
Intervention Description
For subjects 12 to less than (<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to < 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to < 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided.
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Intervention Description
For subjects 13 to <18 years of age, the dosage of ertapenem was 1 gram (g) OD. For subjects 3 months to < 13 years of age, the dosage was 15 mg/kg q12h not to exceed 1 g/day.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin/Clavulanate
Intervention Description
Subjects 2 years to < 18 years of age who were switched from IV to PO therapy receive amoxicillin/clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h). The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded).
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin placebo
Intervention Description
Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV moxifloxacin. Tablets containing inactive ingredients were used as the placebo for PO moxifloxacin 400 mg and 50 mg tablets.
Intervention Type
Drug
Intervention Name(s)
Ertapenem placebo
Intervention Description
Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin/Clavulanate placebo
Intervention Description
Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension.
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events
Description
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Title
Number of Subjects With Clinical Cardiac Adverse Events
Time Frame
Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.
Title
Number of Subjects With Musculoskeletal Adverse Events
Time Frame
All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Secondary Outcome Measure Information:
Title
Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term
Description
Musculoskeletal adverse events were classified as following SOCs (preferred terms): "injury, poisoning and procedural complications" (forearm fracture, joint injury, ligament sprain, muscle strain) "musculoskeletal and connective tissue disorders" (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms.
Time Frame
All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.
Title
Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Description
"N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Description
The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Description
The RR interval refers to the respective time interval in the Electrocardiogram. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3
Description
The QRS interval represents the time it takes for ventricular depolarization to occur. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Description
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Description
QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
Description
QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3
Description
A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3
Description
A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. "N" signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported.
Time Frame
Baseline (Pre-dose), Day 1, Day 3
Title
Clinical Response at Test-of-Cure (TOC) Visit
Description
Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.
Time Frame
28 to 42 days
Title
Bacteriological Response at Test-of-Cure (TOC) Visit
Description
Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate. 'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported.
Time Frame
28 to 42 days
Title
Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)
Description
Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported
Time Frame
28 to 42 days
Title
Clinical Response at a 'During Therapy' Visit
Description
Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy. 'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported.
Time Frame
Day 3 to Day 5
Title
Bacteriological Response at a 'During Therapy' Visit
Description
Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported
Time Frame
Day 3 to Day 5
Title
Clinical Response at the End-of-Treatment (EOT) Visit
Description
Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.
Time Frame
Day 5 to Day 14
Title
Bacteriological Response at the End of Treatment (EOT) Visit
Description
Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.
Time Frame
Day 5 to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized males or females 3 months to 17 years of age Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations Expected duration of treatment with antibiotics is a minimum of 3 days administered IV, for a total of 5 to 14 days administered IV or IV followed by PO If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit or be capable of practicing an adequate method of contraception, and agree to continue the same method for 1 month following the TOC visit. Lactating subjects are not to be included. Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous drainage) confirmed cIAI revealing at least one of the following: Gross peritoneal inflammation with purulent exudate within the abdominal cavity Intra-abdominal abscess Macroscopic intestinal perforation with diffuse peritonitis OR Subjects may be enrolled on the basis of a suspected cIAI, which must be supported with radiological evidence (ultrasound, abdominal plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of gastrointestinal perforation or localized collections of potentially infected material and at least one of the following: Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain) Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity Fever Leukocytosis The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage. Exclusion Criteria: Presumed spontaneous bacterial peritonitis All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis Early acute or suppurative (nonperforated) appendicitis unless there is evidence of an abscess or peritoneal fluid containing pus and micro-organisms suggestive of regional contamination Infections originating from the female genital tract Known severe immunosuppression. Subjects with known mild immunosuppression (eg, Type I or II diabetes mellitus, trauma, or absolute neutrophil count [ANC] between 1000 and 1500 cells/mm3) may be enrolled. Congenital or documented acquired QT prolongation Receiving concomitant treatment with QT prolonging drugs History of tendon disease/disorder related to quinolone treatment Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease) History of myasthenia gravis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Hospital de Agudos "Dr. Carlos Bocalandro"
City
Tres De Febrero
State/Province
Buenos Aires
ZIP/Postal Code
1657
Country
Argentina
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
City
Santiago
Country
Chile
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70176
Country
Germany
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93049
Country
Germany
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42283
Country
Germany
City
Athens
ZIP/Postal Code
115 27
Country
Greece
City
Budapest
ZIP/Postal Code
1086
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
City
Rezekne
ZIP/Postal Code
LV-4601
Country
Latvia
City
Riga
ZIP/Postal Code
LV1004
Country
Latvia
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
México, D.F.
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
City
Ecatepec de Morelos
State/Province
Estado De Mexico
ZIP/Postal Code
55020
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
C.P. 44280
Country
Mexico
City
Cusco
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 1
Country
Peru
City
Lima
Country
Peru
City
Iasi
ZIP/Postal Code
700309
Country
Romania
City
Timisoara
ZIP/Postal Code
300011
Country
Romania
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
City
Vladikavkaz
ZIP/Postal Code
362019
Country
Russian Federation
City
Dnipropetrovsk
ZIP/Postal Code
49100
Country
Ukraine
City
Ivano-Frankovsk
ZIP/Postal Code
76006
Country
Ukraine
City
Lviv
ZIP/Postal Code
79004
Country
Ukraine
City
Simferopol
ZIP/Postal Code
95034
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
29356761
Citation
Wirth S, Emil SGS, Engelis A, Digtyar V, Criollo M, DiCasoli C, Stass H, Willmann S, Nkulikiyinka R, Grossmann U; MOXIPEDIA Study Group. Moxifloxacin in Pediatric Patients With Complicated Intra-abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study. Pediatr Infect Dis J. 2018 Aug;37(8):e207-e213. doi: 10.1097/INF.0000000000001910.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

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