Trials / Completed
CompletedNCT01014013
Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
A Prospective, Multicenter, Partially-Blinded, Randomized, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of INVANZ Versus Ceftriaxone Sodium in the Treatment of Complicated Urinary Tract Infections in Adults
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 271 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ertapenem sodium (MK0826) | a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed) |
| DRUG | Comparator: ceftriaxone sodium | a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy) |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2009-11-16
- Last updated
- 2017-03-22
- Results posted
- 2010-03-01
Source: ClinicalTrials.gov record NCT01014013. Inclusion in this directory is not an endorsement.