Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)

Urinary Tract Infections Clinical Trial

Official title:

A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Local Tolerability, and Clinical Outcome of Ertapenem Versus Ceftriaxone in Pediatric Patients With Complicated Urinary Tract Infection, Skin and Soft Tissue Infection, or Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451386
• Other study ID #: 0826-036
• Secondary ID: 2007_525
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2007
• Last updated: February 16, 2017
• Start date: January 2002
• Est. completion date: December 2003

Study information

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

Clinical Trial Summary

This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 17 Years

Eligibility

Inclusion Criteria:

• Patients with UTI must have white blood cells and bacteria in the urine with bladder catheterization or urologic abnormality, kidney infection or both

• Patients with SSTI must have a recent infection

• Patients with CAP must have a chest x-ray indicating bacterial pneumonia and a fever

Exclusion Criteria:

• Patients with complete urinary tract blockage or kidney abscess

• Patients with infected burn wounds, bone infection, or bacterial arthritis

• Patients on mechanical ventilation or those with cystic fibrosis, chronic lung disease or puss in the space between the chest wall and lung

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Communicable Diseases
• Infection
• Pneumonia
• Pneumonia, Bacterial
• Soft Tissue Infections
• Urinary Tract Infections

Intervention

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

• Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Arguedas A, Cespedes J, Botet FA, Blumer J, Yogev R, Gesser R, Wang J, West J, Snyder T, Wimmer W; Protocol 036 Study Group.. Safety and tolerability of ertapenem versus ceftriaxone in a double-blind study performed in children with complicated urinary tract infection, community-acquired pneumonia or skin and soft-tissue infection. Int J Antimicrob Agents. 2009 Feb;33(2):163-7. doi: 10.1016/j.ijantimicag.2008.08.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the incidence of any clinical and/or laboratory drug-related serious adverse experience during the parenteral therapy period in pediatric patients treated with ertapenem.
Secondary	To compare the safety of ertapenem versus ceftriaxone during the parenteral therapy period with respect to the proportion of patients with any drug-related adverse experiences in pediatric patients with UTI, SSTI, or CAP.