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Completed

NCT Number: NCT01014013

Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

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

  • Adult patients with a suspected or documented complicated urinary tract infection
  • Female patients must test negative for pregnancy and agree to use adequate birth control measures
  • Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy

Exclusion criteria

  • Patients with complete obstruction of any portion of the urinary tract
  • Patients with rapidly progressive or terminal illness
  • Renal transplant patients

Treatment and study plan

ertapenem sodium (MK0826)

Drug

a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed)

Other names: MK0826

Comparator: ceftriaxone sodium

Drug

a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)

Primary outcomes

  1. Microbiological Response Assessment Profile

    Time frame: 5 to 9 days post-therapy

    The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed

  2. The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment

    Time frame: Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days

    Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.

Secondary outcomes

  1. Clinical Response Assessment Profile

    Time frame: 5 to 9 days post-therapy

    The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Prospective, Multicenter, Partially-Blinded, Randomized, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of INVANZ Versus Ceftriaxone Sodium in the Treatment of Complicated Urinary Tract Infections in Adults

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 16, 2009
Registry last updated
Mar 22, 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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