Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
Condition: Intraabdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: Moxifloxacin (Avelox, BAY12-8039); Ertapenem; Amoxicillin/Clavulanate; Moxifloxacin placebo; Ertapenem placebo; Amoxicillin/Clavulanate placebo
Intervention description: 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.; 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.; 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).; 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.; Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem.; Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension.
Intervention MeSH terms: Amoxicillin; Moxifloxacin; Clavulanic Acid; Clavulanic Acids; Ertapenem; Amoxicillin-Potassium Clavulanate Combination; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 458.0
Sex: All
Minimum age: 3 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Intra-abdominal infection; Pediatric infection

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.
    

Eligibility 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