A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections
The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections|
- Safety and tolerability [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
- Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment [ Time Frame: 14 days after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Arm 1: ertapenem sodium
Drug: ertapenem sodium
ertapenem sodium as a single dose of 1gm I.V. was infused over a 30 min interval for a minimum of 3 days to a maximum of 14 days.