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
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
-
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.