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 - Moxifloxacin in pediatric subjects with complicated intra-abdominal infectio
- Conditions
- Complicated intra-abdominal infections (cIAI)MedDRA version: 12.0Level: LLTClassification code 10056570Term: Intra-abdominal infection
- Registration Number
- EUCTR2009-015578-37-BE
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 478
1. Hospitalized males or females 3 months to 17 years of age.
2. Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations.
3. 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.
4. If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit, be capable of practicing one of the following methods of contraception, and agree to continue the same method for 1 month following the TOC visit: Oral contraceptive at a stable dose for one menstrual cycle prior to the start of the study, contraceptive implant inserted at least one month prior to the start of the study, or contraceptive injection administered one month prior to the start of the study; intrauterine device; barrier method plus spermicide; spousal/partner sterility; or abstinence. Subjects taking oral contraceptives should additionally use barrier contraception plus spermicide or abstinence during study drug exposure.
5. 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, and/or
• Intra-abdominal abscess, and/or
• 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:
?• Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
• 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 (body temperature > 38.0°C (100.4 °Fahrenheit) oral; > 38.5°C (101.3° Fahrenheit) rectal or tympanic membrane)
• Leukocytosis (white blood cell [WBC] = 12,000 cells/mm3)
AND
The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Presumed spontaneous bacterial peritonitis
2. All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis
3. 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
4. Infections originating from the female genital tract
5. Known severe immunosuppression (eg, known neutropenia with absolute neutrophil count < 1000/mm3 caused by immunosuppressant therapy or malignancy, known lymphopenia with absolute CD4 + T-cell count < 200/mm3, presenting with an Acquired Immunodeficiency Syndrome [AIDS]-defining event and/or concomitant antiretroviral therapy [Note: Human immuno-deficiency virus {HIV} testing is not required for this study protocol], chronic treatment [= 2 weeks] with known immunosuppressive therapy [including treatment with systemic prednisone or equivalent] or any other congenital or acquired immune defect or 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.
6. Congenital or documented acquired QT prolongation
7. Receiving concomitant treatment with QT prolonging drugs
8. History of tendon disease/disorder related to quinolone treatment
9. Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs
10. 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method