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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)

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ClinicalTrials.gov Identifier: NCT00379951
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 pyelonephritis in indian adults.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Drug: ertapenem sodium Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379951


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
 Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents