Phase 3
N=271
Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01014013 ↗Enrolled (actual)
271
Serious AEs
7.5%
Results posted
Mar 2010
Primary outcome: Primary: Microbiological Response Assessment Profile — 58; 63 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ertapenem sodium (MK0826) (Drug); Comparator: ceftriaxone sodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2009
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 | — |
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.
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.