Condition category
Infections and Infestations
Date applied
14/01/2005
Date assigned
19/01/2005
Last edited
13/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christina Y. Chan

ORCID ID

Contact details

Merck & Co.
Inc.
One Merck Drive
Whitehouse Station
08889-0100
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MK-0826 Protocol 802

Study information

Scientific title

A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults

Acronym

OASIS II

Study hypothesis

Not provided at time of registration

As of 13/08/09 this record has been extensively updated. All updates can be found in the relevant field with the above update date. Please also note that the country of recruitment has been corrected, initially USA was entered in error.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Complicated intra-abdominal infections

Intervention

Current information as of 13/08/09:
Adult patients with intra-abdominal infections requiring surgery were eligible for this open-label randomized trial comparing ertapenem 1 g daily with ceftriaxone 2 g daily plus metronidazole 30 mg/kg/day.

Initial information at time of registration:
Ertapenem, ceftriaxone, metronidazole

Intervention type

Drug

Phase

Not Specified

Drug names

Ertapenem, ceftriaxone, metronidazole

Primary outcome measures

Added 13/08/09:
Efficacy as measured by clinical response rate in clinically and microbiologically evaluable participants at the test-of-cure (TOC) visit 2 weeks after discontinuation of therapy

Secondary outcome measures

Added 13/08/09:
Efficacy measured at TOC visit 4 weeks after discontinuation of therapy

Overall trial start date

01/06/2002

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 13/08/09:
1. Male or female patients aged 18 or over
2. Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

Initial information at time of registration:
Adult patients with intra-abdominal infections requiring surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Added 13/08/09:
1. Patient has another infection, other than abdominal
2. Female patient is pregnant or planning to become pregnant

Recruitment start date

01/06/2002

Recruitment end date

30/06/2003

Locations

Countries of recruitment

Philippines

Trial participating centre

Merck & Co., Inc.
Whitehouse Station
08889-0100
United States of America

Sponsor information

Organisation

Merck and Co., Inc. (USA)

Sponsor details

Christina Y. Chan
M.D.
One Merck Drive
Whitehouse Station
08889-0100
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Merck & Co., Inc. (USA)

Alternative name(s)

Merck & Co., Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/17462256

Publication citations

  1. Results

    Navarro NS, Campos MI, Alvarado R, Quintero N, Branicki FJ, Wei J, Shivaprakash M, Vrijens F, Giezek H, Chan CY, DiNubile MJ, , 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.

Additional files

Editorial Notes