NCT01014013

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

Completed Phase 3 Results posted Last updated 16 February 2017

What this trial tests

Phase 3 trial testing ertapenem sodium (MK0826) in Urinary Tract Infection in 271 participants. Completed in 1 February 2009.

Timeline

1 April 2008

Primary endpoint
1 February 2009

1 February 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	271
Start date	1 April 2008
Primary completion	1 February 2009
Estimated completion	1 February 2009

Drugs / interventions tested

• ertapenem sodium (MK0826) — full drug profile →
• Comparator: ceftriaxone sodium — full drug profile →

Conditions studied

• Urinary Tract Infection — all drugs for Urinary Tract Infection →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Urinary Tract Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• 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-r

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.