A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00379951

Purpose

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.

Condition	Intervention	Phase
Urinary Tract Infection	Drug: ertapenem sodium	Phase III

MedlinePlus related topics: Dietary Sodium Urinary Tract Infections

Drug Information available for: Ertapenem L 749345

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	107
Study Start Date:	June 2005
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: ertapenem sodium	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379951

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_036
Study First Received:	September 22, 2006
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00379951
Health Authority:	India: Indian Council of Medical Research

Study placed in the following topic categories:

Ertapenem
Urologic Diseases
Urinary Tract Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009