NCT00092170

Brief Summary

The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2004

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

September 21, 2004

Last Update Submit

February 16, 2017

Conditions

InfectionsPelvic Infections

Keywords

Intra-abdominal infectionsAcute pelvic infections

Outcome Measures

Primary Outcomes (1)

  • Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy

Interventions

MK0826, ertapenem sodiumDRUG
Comparator: Ticarcillin/ClavulanateDRUG

Eligibility Criteria

Age3 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection

You may not qualify if:

  • Immune problems
  • Kidney problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yellin AE, Johnson J, Higareda I, Congeni BL, Arrieta AC, Fernsler D, West J, Gesser R. Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients. Am J Surg. 2007 Sep;194(3):367-74. doi: 10.1016/j.amjsurg.2007.01.023.

    PMID: 17693284BACKGROUND

MeSH Terms

Conditions

InfectionsPelvic InfectionIntraabdominal Infections

Interventions

ErtapenemClavulanic Acid

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsClavulanic Acids

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2004

First Posted

September 24, 2004

Study Start

March 1, 2002

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

February 17, 2017

Record last verified: 2017-02