A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)

Urinary Tract Infection Clinical Trial

Official title:

A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379951
• Other study ID #: 0826-048
• Secondary ID: 2006_036
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2006
• Last updated: February 16, 2017
• Start date: June 2005
• Est. completion date: May 2006

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has a complicated urinary tract infection

• Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture

• Patient is indian and 18 years of age or greater.

Exclusion Criteria:

• Patient had a kidney transplant

• Patient had been given antibiotic therapy for condition

• Patient had poor liver function

• Patient has complete obstruction of urinary tract

• Patient has history of serious allergy to antibiotics and multivitamins

• Patient is pregnant

• Patient not likely to respond to 10 to 14 days of antibiotic therapy

• Patient not likely to survive 4 week study period

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• ertapenem sodium
ertapenem sodium as a single dose of 1gm I.V. was infused over a 30 min interval for a minimum of 3 days to a maximum of 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		14 Days
Secondary	Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment		14 days after treatment