Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection (MOXIPEDIA)
Intraabdominal Infections
About this trial
This is an interventional treatment trial for Intraabdominal Infections focused on measuring Intra-abdominal infection, Pediatric infection
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
Sites / Locations
- Hospital de Agudos "Dr. Carlos Bocalandro"
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Moxifloxacin (Avelox, BAY12-8039)
Comparator Ertapenem
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.
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.