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CompletedNCT00451386Updated Feb 17, 2017

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

A Phase 2 interventional study of MK0826, ertapenem sodium /Duration of Treatment: 14 Days and Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days in Urinary Tract Infections, Bacterial Pneumonia and Soft Tissue Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
3 Months to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Urinary Tract Infections
  • Bacterial Pneumonia
  • Soft Tissue Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 400 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
400 participants

Interventions

  • DrugMK0826, ertapenem sodium /Duration of Treatment: 14 Days
  • DrugComparator: ceftriaxone sodium /Duration of Treatment: 14 Days
06

What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18945594 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00451386
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Mar 23, 2007
Start date
Jan 2002
Primary completion
Dec 2003
Completion
Dec 2003
Last update
Feb 17, 2017

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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