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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: February 16, 2017
Last verified: February 2017
  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
Intervention Model: Single Group Assignment
Masking: No masking
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:


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

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 14 Days ]

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 ]

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)
Sexes Eligible for Study:   All
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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

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: February 16, 2017

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 June 26, 2017