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ISRCTN
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ISRCTN84455313
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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 cefepime 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 cefepime and sulbactam in complicated upper and lower tract infections
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Acronym
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N/A
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Serial number at source
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venus/cefepime_sulbactam/082006A
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Study hypothesis
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The objectives were:
1. To study the efficacy of fixed dose combination of cefepime and sulbactam injections in in complicated upper and lower tract infections
2. To assess comaprative safety of study drug
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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/04-2007/02/VENUS/CEFEPIME_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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Complicated upper and lower tract infections
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Participants - inclusion criteria
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1. Participants aged greater than 18 years (n = 102), either sex
2. Suffering from lower respiratory tract infections caused by gram negative organisms including pseudomonas aeruginosa
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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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102
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Interventions
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Fixed dose combination of cefepime 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 on 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 on 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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