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A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00157898
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.

Condition or disease Intervention/treatment Phase
Complicated Intra-abdominal Infection Drug: MK0826; ertapenem sodium Drug: Comparator: ceftriaxone + metronidazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open, Randomized, Comparative Study to Evaluate the Safety and Efficacy of Ertapenem Versus it's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults
Study Start Date : January 2004
Actual Primary Completion Date : August 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Favorable clinical response at 7-14 days after treatment

Secondary Outcome Measures :
  1. Favorable microbiologic response at 7-14 days after treatment


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.

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): NCT00157898


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157898     History of Changes
Other Study ID Numbers: 0826-050
MK0826-050
2005_068
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Infection
Communicable Diseases
Intraabdominal Infections
Ertapenem
Metronidazole
Ceftriaxone
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents