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Completed

NCT Number: NCT00481702

A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)

A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.

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Key information

Conditions

Intra-abdominal Infection Infections Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients age 18 or older
  • Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

Exclusion criteria

  • Patient has another infection, other than abdominal
  • Female patient is pregnant or planning to become pregnant

Treatment and study plan

Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks

Drug

MK0826, /Duration of Treatment : 8 Weeks

Drug

Comparator: metronidazole / Duration of Treatment: 8 Weeks

Drug

Primary outcomes

  1. That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection

    Time frame: 2 weeks after treatment

Secondary outcomes

  1. That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection

    Time frame: 4 weeks after treatment

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Jun 4, 2007
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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