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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00379951

First received: September 22, 2006

Last updated: November 3, 2015

Last verified: November 2015

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Ertapenem sodium Ertapenem

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

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
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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. Other Names: MK0826 Invanz

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00379951 History of Changes
Other Study ID Numbers:	0826-048 2006_036
Study First Received:	September 22, 2006
Last Updated:	November 3, 2015
Health Authority:	India: DCGI

Additional relevant MeSH terms:


Infection Communicable Diseases Urinary Tract Infections Urologic Diseases	Ertapenem Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 28, 2016

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