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

Bayer

Status and phase: Completed; Phase 3

Conditions: Intraabdominal Infections

Treatments: Drug: Moxifloxacin placebo; Drug: Moxifloxacin (Avelox, BAY12-8039); Drug: Ertapenem; Drug: Amoxicillin/Clavulanate placebo; Drug: Amoxicillin/Clavulanate; Drug: Ertapenem placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069900

2009-015578-37 (EudraCT Number)

11643 (Registry Identifier)

1962 (Avelox pediatrics) (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 458 patients

Sex: All

Ages: 3 months to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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458 participants in 2 patient groups

Moxifloxacin (Avelox, BAY12-8039)

Experimental group

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.

Treatment:

Drug: Amoxicillin/Clavulanate placebo

Drug: Ertapenem placebo

Drug: Moxifloxacin (Avelox, BAY12-8039)

Comparator Ertapenem

Active Comparator group

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.

Treatment:

Drug: Ertapenem

Drug: Amoxicillin/Clavulanate

Drug: Moxifloxacin placebo