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OpenTrials
Completed

NCT Number: NCT00398099

To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

To collect clinical response data with the use of ertapenem in approved indications.

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Key information

Conditions

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

Age range

20 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, 20 years of age or older
  • Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
  • Patients who required therapy prior to identification of cause of infection

Exclusion criteria

  • Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
  • Patient has an apache ii > 30.
  • Patient has an infection caused by pathogens resistant to ertapenem
  • Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
  • The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)

Treatment and study plan

MK0826, ertapenem sodium / Duration of Treatment: 14 Days

Drug

Primary outcomes

  1. Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment

Secondary outcomes

  1. Safety and Tolerability

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 10, 2006
Registry last updated
Feb 17, 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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