NCT00157898

Brief Summary

This was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_4

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

January 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

September 7, 2005

Last Update Submit

February 17, 2017

Conditions

Complicated Intra-abdominal Infection

Outcome Measures

Primary Outcomes (1)

  • Favorable clinical response at 7-14 days after treatment

Secondary Outcomes (1)

  • Favorable microbiologic response at 7-14 days after treatment

Interventions

MK0826; ertapenem sodiumDRUG
Comparator: ceftriaxone + metronidazoleDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

ErtapenemMetronidazole

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

January 1, 2004

Primary Completion

August 1, 2004

Study Completion

September 1, 2004

Last Updated

February 20, 2017

Record last verified: 2017-02