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ISRCTN
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ISRCTN42833283
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ClinicalTrials.gov identifier
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Public title
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Efficacy and safety of the fixed dose combination of cefpirome and sulbactam
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Scientific title
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Multicentric, open labelled, non randomised, clinical trial to assess efficacy and safety of the fixed dose combination of cefpirome and sulbactam in bacteraemia/septicaemia and severe infections in intensive care patients
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Acronym
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N/A
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Serial number at source
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venus/cefpirome_sulbactam/082006A
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Study hypothesis
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The objective of the trial was to study the efficacy of fixed dose combination of cefpirome and sulbactam injections in bacteraemia/septicaemia and severe infections in intensive care patients.
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Ethics approval
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Ethics approval received from the National Ethic Committee, Ahembdabad on the 28th April 2007 (date of issue of letter: 2nd May 2007) (ref: NEC/04-2007/04/VENUS/CEFPIROME_SULBACTAM/082006A).
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Study design
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Open labelled, non randomised, multicentric clinical trial
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Countries of recruitment
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India
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Disease/condition/study domain
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Bacteraemia/septicaemia and severe infections
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Participants - inclusion criteria
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1. Participants aged greater than 18 years (n = 103), either sex
2. Suffering from bacteraemia/septicaemia and severe infections
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Participants - exclusion criteria
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1. History of hypersensitivity reaction or any specific contraindication to beta lactams
2. Presence of hepatic or renal disorders
3. Pregnancy or lactation
4. History of hearing loss
5. Alcoholics
6. Previous history seizure
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Anticipated start date
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01/05/2007
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Anticipated end date
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31/07/2007
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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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103
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Interventions
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Fixed dose combination of cefpirome and sulbactam (1.5 g to 3 g, intravenous [i.v.] twice daily). Duration of treatment 7 to 10 days, followed for 7 days after the treatment.
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Primary outcome measure(s)
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Improvement in clinical and laboratory parameters, measured at day 0, day 3 and day 7 (completion of treatment).
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Secondary outcome measure(s)
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To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured at day 0, day 3 and day 7 (completion of treatment).
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Sources of funding
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Venus Remedies Limited (India)
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Trial website
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Publications
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Contact name
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Dr
Nitin
Rathod
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Address
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Dr R N Cooper Municipal General Hospital
Ville Parle
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City/town
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Mumbai
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Zip/Postcode
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400056
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Country
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India
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Email
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drnmrathod@hotmail.com
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Sponsor
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Venus Remedies Limited (India)
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Address
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51 - 52 Industrial Area
Phase - I
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City/town
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Panchkula, Haryana
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Zip/Postcode
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134113
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Country
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India
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Email
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research@venusremedies.com
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Sponsor website:
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http://www.venusremedies.com
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Date applied
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04/03/2008
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Last edited
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15/05/2008
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Date ISRCTN assigned
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15/05/2008
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