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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01069900
First received: February 15, 2010
Last updated: February 16, 2016
Last verified: January 2016
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Intraabdominal Infections
Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Ertapenem
Drug: Amoxicillin/Clavulanate
Drug: Moxifloxacin placebo
Drug: Ertapenem placebo
Drug: Amoxicillin/Clavulanate placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at multicenter between 21 July 2010 (first subject first visit) to 21 January 2015 (last subject last visit).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall 478 subjects were enrolled, 20 subjects had screening failures hence, 458 subjects were randomized to receive treatment.

Reporting Groups
  Description
Moxifloxacin (Avelox, BAY12-8039) 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.
Comparator Ertapenem 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.

Participant Flow:   Overall Study
    Moxifloxacin (Avelox, BAY12-8039)     Comparator Ertapenem  
STARTED     305     153  
Treated     301     150  
COMPLETED     287     149  
NOT COMPLETED     18     4  
Technical problems                 0                 1  
Lost to Follow-up                 7                 1  
Withdrawal by Subject                 6                 1  
Protocol Violation                 4                 1  
Insufficient Therapeutic effect                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Moxifloxacin (Avelox, BAY12-8039) 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.
Comparator Ertapenem 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.
Total Total of all reporting groups

Baseline Measures
    Moxifloxacin (Avelox, BAY12-8039)     Comparator Ertapenem     Total  
Number of Participants  
[units: participants]
  305     153     458  
Age  
[units: years]
Mean (Standard Deviation)
  12.05  (3.66)     12.046  (3.495)     12.049  (3.602)  
Age, Customized  
[units: Subjects]
     
12 - < 18 years     190     94     284  
6 - < 12 years     100     52     152  
2 - < 6 years     14     7     21  
3 months - < 2 years     1     0     1  
Gender  
[units: Subjects]
     
Female     124     53     177  
Male     181     100     281  



  Outcome Measures
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1.  Primary:   Number of Subjects With 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. ]

2.  Primary:   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. ]

3.  Primary:   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. ]

4.  Secondary:   Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term   [ 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. ]

5.  Secondary:   Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

6.  Secondary:   PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

7.  Secondary:   RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

8.  Secondary:   QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

9.  Secondary:   QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

10.  Secondary:   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   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

11.  Secondary:   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   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

12.  Secondary:   Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

13.  Secondary:   Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3   [ Time Frame: Baseline (Pre-dose), Day 1, Day 3 ]

14.  Secondary:   Clinical Response at Test-of-Cure (TOC) Visit   [ Time Frame: 28 to 42 days ]

15.  Secondary:   Bacteriological Response at Test-of-Cure (TOC) Visit   [ Time Frame: 28 to 42 days ]

16.  Secondary:   Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)   [ Time Frame: 28 to 42 days ]

17.  Secondary:   Clinical Response at a ‘During Therapy’ Visit   [ Time Frame: Day 3 to Day 5 ]

18.  Secondary:   Bacteriological Response at a ‘During Therapy’ Visit   [ Time Frame: Day 3 to Day 5 ]

19.  Secondary:   Clinical Response at the End-of-Treatment (EOT) Visit   [ Time Frame: Day 5 to Day 14 ]

20.  Secondary:   Bacteriological Response at the End of Treatment (EOT) Visit   [ Time Frame: Day 5 to Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com



Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01069900     History of Changes
Other Study ID Numbers: 11643
2009-015578-37 ( EudraCT Number )
1962 (Avelox pediatrics) ( Other Identifier: Company internal )
Study First Received: February 15, 2010
Results First Received: November 4, 2015
Last Updated: February 16, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Romania: National Medicines Agency
Russia: FSI Scientific Center of Expertise of Medical Application
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration