Phase 3
Completed N=271
Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
Source: ClinicalTrials.gov NCT01014013 ↗Enrolled (actual)
271
Serious AEs
7.5%
Results posted
Mar 2010
Primary outcomePrimary: Microbiological Response Assessment Profile — 58; 63 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microbiological Response Assessment Profile |
58; 63 | — |
| PRIMARY The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment |
1; 0; 0; 0; 1; 1 | — |
| SECONDARY Clinical Response Assessment Profile |
64; 70 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients with a suspected or documented complicated urinary tract infection
- Female patients must test negative for pregnancy and agree to use adequate birth control measures
- Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy
Exclusion Criteria
- Patients with complete obstruction of any portion of the urinary tract
- Patients with rapidly progressive or terminal illness
- Renal transplant patients
Data sourced from ClinicalTrials.gov (NCT01014013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.