A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults
18 Years
65 Years
Both
Complicated Intra-Abdominal Infections
Trial Information
A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults
Inclusion Criteria:
- complicated intra-abdominal infections
Exclusion Criteria:
- infections limited to hollow viscus
- ischemic bowel disease without perforation
- acute suppurative cholangitis
- acute necrotizing pancreatitis
- pts to undergo stated abdominal repair, open abdomen technique or marsupialization
- Apache II >25
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To estimate the efficacy of NXL104/ceftazidime with respect to the clinical response in baseline microbiologically evaluable patients with cIAI at the Test of Cure (TOC) visit
Outcome Time Frame:
2 weeks post-treatment
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
NXL104/2002
NCT ID:
NCT00752219
Start Date:
March 2009
Completion Date:
December 2009
Related Keywords:
- Complicated Intra-Abdominal Infections
Name | Location |
|---|---|
| Henry Ford Health System | Detroit, Michigan 48202 |
| University of Southern California | Los Angeles, California 90033 |
| Mercury Street Medical Group | Butte, Montana 59701 |
| Summa Health Systems | Akron, Ohio 44304 |
| South Jersey Infectious Disease | Somers Point, New Jersey 08244 |
| Cedars-Sinai Medical Center Dept of Surgery | Los Angeles, California |
| Michael S. Somero Research Division | Palm Springs, California |
| Remington-Daviss Inc | Columbus, Ohio |
| ID Clinical Research Ltd | Toledo, Ohio |
