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: July 1, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Intraabdominal Infections
Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Ertapenem
Drug: Clavulanate
Drug: Amoxicillin
Phase 3

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
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of Subjects With Adverse Events [ Time Frame: All AEs 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. ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Clinical Cardiac Adverse Events [ Time Frame: All AEs 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. ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Musculoskeletal Adverse Events [ Time Frame: All AEs 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term [ Time Frame: All AEs 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. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical Response at Test-of-Cure (TOC) Visit [ Time Frame: 28 to 42 days ] [ Designated as safety issue: No ]
  • Bacteriological Response at Test-of-Cure (TOC) Visit [ Time Frame: 28 to 42 days ] [ Designated as safety issue: No ]
  • Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI) [ Time Frame: 28 to 42 days ] [ Designated as safety issue: No ]
  • Clinical Response at a 'During Therapy' Visit [ Time Frame: Day 3 to Day 5 ] [ Designated as safety issue: No ]
  • Bacteriological Response at a 'During Therapy' Visit [ Time Frame: Day 3 to Day 5 ] [ Designated as safety issue: No ]
  • Clinical Response at the End-of-Treatment (EOT) Visit [ Time Frame: Day 5 to Day 14 ] [ Designated as safety issue: No ]
  • Bacteriological response at the End of Treatment (EOT) visit [ Time Frame: Day 5 to Day 14 ] [ Designated as safety issue: No ]

Enrollment: 478
Study Start Date: July 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Moxifloxacin (Avelox, BAY12-8039)

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. 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.

Active Comparator: 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.
Drug: Ertapenem
For subjects 13 to <18 years of age, the dosage of ertapenem were 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.
Drug: Clavulanate
Subjects 2 years to < 18 years of age who were switched from IV to PO therapy receive clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h).
Drug: Amoxicillin
Subjects 2 years to < 18 years of age who were switched from IV to PO therapy receive amoxicillin suspension. The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded).

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069900

  Show 100 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01069900     History of Changes
Other Study ID Numbers: 11643, 2009-015578-37, 1962 (Avelox pediatrics)
Study First Received: February 15, 2010
Last Updated: July 1, 2015
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

Keywords provided by Bayer:
Intra-abdominal infection
Pediatric infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Intraabdominal Infections
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Ertapenem
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 27, 2015