A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Infection

Treatments: Drug: ertapenem sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00379951

0826-048

2006_036

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a complicated urinary tract infection
• Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture
• Patient is indian and 18 years of age or greater.

Exclusion criteria

• Patient had a kidney transplant
• Patient had been given antibiotic therapy for condition
• Patient had poor liver function
• Patient has complete obstruction of urinary tract
• Patient has history of serious allergy to antibiotics and multivitamins
• Patient is pregnant
• Patient not likely to respond to 10 to 14 days of antibiotic therapy
• Patient not likely to survive 4 week study period

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

1

Experimental group

Description:

Arm 1: ertapenem sodium

Treatment:

Drug: ertapenem sodium