Resumen

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.

Elegibilidad

Edad mínima: 3 MonthsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

History of tendon disease/disorder related to quinolone treatment
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
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

Intervenciones

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.

drug

Ertapenem

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.

drug

Amoxicillin/Clavulanate

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).

drug

Moxifloxacin placebo

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.

drug

Ertapenem placebo

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

drug

Amoxicillin/Clavulanate placebo

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

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Moxifloxacin (Avelox, BAY12-8039)

Ertapenem

Amoxicillin/Clavulanate

Moxifloxacin placebo

Ertapenem placebo

Amoxicillin/Clavulanate placebo

Ubicaciones

Hospital de Agudos "Dr. Carlos Bocalandro"

Patrocinadores