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

NCT01014013 | Completed Phase 3 Results

• 3 other identifiers: 0826-055MK0826-0552009_690
• Study Type: interventional
• Target: 271
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (2)

• Microbiological Response Assessment Profile

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

  5 to 9 days post-therapy

• 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

  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.

  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

Secondary Outcomes (1)

• Clinical Response Assessment Profile

  5 to 9 days post-therapy

Study Arms (2)

ertapenem sodium (MK0826)

EXPERIMENTAL

ertapenem sodium

Drug: ertapenem sodium (MK0826)

ceftriaxone sodium

ACTIVE COMPARATOR

ceftriaxone sodium

Drug: Comparator: ceftriaxone sodium

Interventions

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)

Also known as: MK0826

ertapenem sodium (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)

ceftriaxone sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Park DW, Peck KR, Chung MH, Lee JS, Park YS, Kim HY, Lee MS, Kim JY, Yeom JS, Kim MJ. Comparison of ertapenem and ceftriaxone therapy for acute pyelonephritis and other complicated urinary tract infections in Korean adults: a randomized, double-blind, multicenter trial. J Korean Med Sci. 2012 May;27(5):476-83. doi: 10.3346/jkms.2012.27.5.476. Epub 2012 Apr 25.

  PMID: 22563210 RESULT

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 16, 2009
• Study Start: April 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 22, 2017
• Results First Posted: March 1, 2010

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share