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ISRCTN
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ISRCTN59616541
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ClinicalTrials.gov identifier
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Public title
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Ertapenem versus Ceftriaxone and Metronidazole As Treatment For Complicated Intra-abdominal Infections
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Scientific title
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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
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Acronym
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OASIS II
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Serial number at source
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MK-0826 Protocol 802
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Multicentre randomised open label active controlled parallel group trial
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Countries of recruitment
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Philippines
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Disease/condition/study domain
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Complicated intra-abdominal infections
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Added 13/08/09:
1. Patient has another infection, other than abdominal
2. Female patient is pregnant or planning to become pregnant
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Anticipated start date
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01/06/2002
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Anticipated end date
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30/06/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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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
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Added 13/08/09:
Efficacy measured at TOC visit 4 weeks after discontinuation of therapy
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Sources of funding
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Merck & Co., Inc. (USA)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/17462256
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Contact name
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Dr
Christina Y.
Chan
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Address
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Merck & Co., Inc.
One Merck Drive
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City/town
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Whitehouse Station
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Zip/Postcode
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08889-0100
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Country
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United States of America
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Sponsor
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Merck and Co., Inc. (USA)
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Address
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Christina Y. Chan, M.D.
One Merck Drive
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City/town
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Whitehouse Station
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Zip/Postcode
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08889-0100
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Country
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United States of America
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Date applied
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14/01/2005
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Last edited
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13/08/2009
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Date ISRCTN assigned
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19/01/2005
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