Ertapenem versus Ceftriaxone and Metronidazole As Treatment For Complicated Intra-abdominal Infections
| ISRCTN | ISRCTN59616541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59616541 |
| Secondary identifying numbers | MK-0826 Protocol 802 |
- 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
Scientific
Merck & Co., Inc.
One Merck Drive
Whitehouse Station
08889-0100
United States of America
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ertapenem, ceftriaxone, metronidazole |
| Primary outcome measure | 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 study start date | 01/06/2002 |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
08889-0100
United States of America
Sponsor information
Merck and Co., Inc. (USA)
Industry
Industry
Christina Y. Chan, M.D.
One Merck Drive
Whitehouse Station
08889-0100
United States of America
Funders
Funder type
Industry
Merck & Co., Inc. (USA)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Merck & Co., Inc., Merck & Co.
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
