Clinical Trial: Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

  • 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. ]
    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 [ 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. ]
  • 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. ]


    • Original Primary Outcome: Primary objective of the trial is to evaluate the safety of treatment with moxifloxacin with a special focus on cardiac and musculoskeletal events [ Time Frame: Treatment day 5-14 (end of treatment), day 28-42 after EOT (test-of-cure), 3 and 12 months FU ]

    Current Secondary Outcome:

    • 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. ]
      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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Time Frame: Baseline (Pre-dose), Day 1, 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 [ Ti

      Original Secondary Outcome:

      • Evaluation of musculoskeletal adverse events [ Time Frame: Treatment day 5-14 (end of treatment), day 28-42 after EOT (test-of-cure), 3 and 12 months FU ]
      • Evaluation of electrocardiogram profiles obtained on Day 1 and Day 3 pre-treatment and post-treatment [ Time Frame: Treatment day 3 and 5 ]
      • Evaluation of clinical response at the Test-of-cure visit among subjects with a bacteriologically confirmed complicated intra-abdominal infection [ Time Frame: 28-42 days after end of treatment (test-of-cure) ]
      • Evaluation of clinical and bacteriological response to treatment at a "during therapy" visit (Day 3-5) [ Time Frame: Treatment day 3 or 4 or 5 ]
      • Evaluation of clinical and bacteriological response to treatment at the End of Treatment visit [ Time Frame: Treatment day 5-14 (end of treatment) ]


      Information By: Bayer

      Dates:
      Date Received: February 15, 2010
      Date Started: July 2010
      Date Completion:
      Last Updated: February 16, 2016
      Last Verified: January 2016