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

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.

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ertapenem sodium

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.

Other names: MK0826, Invanz

Primary outcomes

Safety and tolerability

Time frame: 14 Days

Secondary outcomes

Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment

Time frame: 14 days after treatment

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Sep 25, 2006
Registry last updated: Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed