Ertapenem versus Ceftriaxone and Metronidazole As Treatment For Complicated Intra-abdominal Infections

ISRCTN	ISRCTN59616541
DOI	https://doi.org/10.1186/ISRCTN59616541
Protocol serial number	MK-0826 Protocol 802
Sponsor	Merck and Co., Inc. (USA)
Funder	Merck & Co., Inc. (USA)

Submission date: 14/01/2005
Registration date: 19/01/2005
Last edited: 13/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christina Y. Chan
Scientific

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

Study information

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
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
Study acronym	OASIS II
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Ertapenem, ceftriaxone, metronidazole
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Added 13/08/09: Efficacy measured at TOC visit 4 weeks after discontinuation of therapy
Completion date	30/06/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Key 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
Key exclusion criteria	Added 13/08/09: 1. Patient has another infection, other than abdominal 2. Female patient is pregnant or planning to become pregnant
Date of first enrolment	01/06/2002
Date of final enrolment	30/06/2003

Locations

Countries of recruitment

Philippines
United States of America

Study participating centre

Merck & Co., Inc.

Whitehouse Station
08889-0100
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2005		Yes	No