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

NCT ID: NCT00379951

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-05-31

Brief Summary

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Arm 1: ertapenem sodium

Group Type: EXPERIMENTAL

ertapenem sodium

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

MK0826; Invanz

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2006_036

Identifier Type: -

Identifier Source: secondary_id

0826-048

Identifier Type: -

Identifier Source: org_study_id