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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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Complicated Intra-Abdominal Infections

Thank you

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 SystemDetroit, Michigan  48202
University of Southern CaliforniaLos Angeles, California  90033
Mercury Street Medical GroupButte, Montana  59701
Summa Health SystemsAkron, Ohio  44304
South Jersey Infectious DiseaseSomers Point, New Jersey  08244
Cedars-Sinai Medical Center Dept of SurgeryLos Angeles, California  
Michael S. Somero Research DivisionPalm Springs, California  
Remington-Daviss IncColumbus, Ohio  
ID Clinical Research LtdToledo, Ohio