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

NCT00451386 | Completed Phase 2

• 2 other identifiers: 0826-0362007_525
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Tract Infections; Bacterial Pneumonia; Soft Tissue Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

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

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

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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. Epub 2008 Oct 21.

  PMID: 18945594 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections; Pneumonia, Bacterial; Soft Tissue Infections

Interventions

Ertapenem; Duration of Therapy

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 23, 2007
• Study Start: January 1, 2002
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: February 17, 2017

Record last verified: 2017-02