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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Infection
Urinary Tract Infection
Pneumonia

Treatments

Drug: MK0826, ertapenem sodium / Duration of Treatment: 14 Days

Study type

Interventional

Funder types

Industry

Identifiers

NCT00398099
2006_046
0826-052

Details and patient eligibility

About

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

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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