NCT00481702

Brief Summary

A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2001

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

December 1, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

June 1, 2007

Last Update Submit

February 17, 2017

Conditions

Intra-abdominal Infection

Outcome Measures

Primary Outcomes (1)

  • That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection

    2 weeks after treatment

Secondary Outcomes (1)

  • That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection

    4 weeks after treatment

Interventions

Comparator: ceftriaxone sodium / Duration of Treatment: 8 WeeksDRUG
MK0826, /Duration of Treatment : 8 WeeksDRUG
Comparator: metronidazole / Duration of Treatment: 8 WeeksDRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female patients age 18 or older
  • Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

You may not qualify if:

  • Patient has another infection, other than abdominal
  • Female patient is pregnant or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Navarro NS Jr, Campos MI, Alvarado R, Quintero N, Branicki FJ, Wei J, Shivaprakash M, Vrijens F, Giezek H, Chan CY, DiNubile MJ; Oasis II Study Team. Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections. Int J Surg. 2005;3(1):25-34. doi: 10.1016/j.ijsu.2005.03.010.

    PMID: 17462256BACKGROUND

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Duration of TherapyErtapenem

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 4, 2007

Study Start

December 1, 2001

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

February 20, 2017

Record last verified: 2017-02