Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

NCT01069900 | Completed Phase 3 Results DMC

• 3 other identifiers: 116431962 (Avelox pediatrics)2009-015578-37
• Study Type: interventional
• Target: 458
• Locations: 16 countries
• Sites: 39

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.

Conditions

Intraabdominal Infections

Keywords

Intra-abdominal infection; Pediatric infection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

• Number of Subjects With Clinical Cardiac Adverse Events

  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

  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 Outcomes (17)

• Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term

  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.

• Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

  Baseline (Pre-dose), Day 1, Day 3

• PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

  Baseline (Pre-dose), Day 1, Day 3

• RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

  Baseline (Pre-dose), Day 1, Day 3

• QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3

  Baseline (Pre-dose), Day 1, Day 3

Study Arms (2)

Moxifloxacin (Avelox, BAY12-8039)

EXPERIMENTAL

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); Drug: Ertapenem placebo; Drug: Amoxicillin/Clavulanate placebo

Comparator Ertapenem

ACTIVE COMPARATOR

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; Drug: Amoxicillin/Clavulanate; Drug: Moxifloxacin placebo

Interventions

Moxifloxacin (Avelox, BAY12-8039) DRUG

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.

Moxifloxacin (Avelox, BAY12-8039)

Ertapenem DRUG

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.

Comparator Ertapenem

Amoxicillin/Clavulanate DRUG

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).

Comparator Ertapenem

Moxifloxacin placebo DRUG

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.

Comparator Ertapenem

Ertapenem placebo DRUG

Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem.

Moxifloxacin (Avelox, BAY12-8039)

Amoxicillin/Clavulanate placebo DRUG

Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension.

Moxifloxacin (Avelox, BAY12-8039)

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (39)

Unknown Facility

San Diego, California, 92123, United States

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Springfield, Massachusetts, 01199, United States

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Hospital de Agudos "Dr. Carlos Bocalandro"

Tres de Febrero, Buenos Aires, 1657, Argentina

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1606, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Calgary, Alberta, T3B 6A8, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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Montreal, Quebec, H3H 1P3, Canada

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Santiago, Chile

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Olomouc, 77520, Czechia

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Prague, 150 06, Czechia

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Stuttgart, Baden-Wurttemberg, 70176, Germany

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Regensburg, Bavaria, 93049, Germany

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Wuppertal, North Rhine-Westphalia, 42283, Germany

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Athens, 115 27, Greece

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Budapest, 1086, Hungary

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Győr, 9024, Hungary

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Daugavpils, LV-5417, Latvia

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Rēzekne, LV-4601, Latvia

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Riga, LV1004, Latvia

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Kaunas, LT-50009, Lithuania

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Vilnius, LT-08661, Lithuania

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Guadalajara, Jalisco, C.P. 44280, Mexico

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México, D.F., Mexico City, 04530, Mexico

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Ecatepec de Morelos, State of Mexico, 55020, Mexico

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Cusco, Peru

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Lima, LIMA 1, Peru

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Lima, Peru

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Iași, 700309, Romania

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Timișoara, 300011, Romania

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Smolensk, 214019, Russia

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Vladikavkaz, 362019, Russia

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Dnipropetrovsk, 49100, Ukraine

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Ivano-Frankivsk, 76006, Ukraine

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Lviv, 79004, Ukraine

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Simferopol, 95034, Ukraine

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Related Publications (1)

• 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.

  PMID: 29356761 RESULT

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Moxifloxacin; Ertapenem; Amoxicillin-Potassium Clavulanate Combination; Amoxicillin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Clavulanic Acid; Clavulanic Acids; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: July 21, 2010
• Primary Completion: January 21, 2015
• Study Completion: January 21, 2015
• Last Updated: March 20, 2018
• Results First Posted: December 8, 2015

Record last verified: 2018-02

Locations

US (2); LA (3); GR (1); LI (2); AR (1); RU (2); HU (2); RO (2); DE (3); CL (1); CA (3); UA (4); PE (3); CZ (2); BU (5); ME (3)