Status:

COMPLETED

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Urinary Tract Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 pyelonephriti...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2006

Estimated Enrollment :

107 Patients enrolled

Trial Details

Trial ID

NCT00379951

Start Date

June 1 2005

End Date

May 1 2006

Last Update

February 17 2017

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