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ISRCTN
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ISRCTN61799591
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ClinicalTrials.gov identifier
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Public title
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Safety and efficacy of a fixed dose combination of cefepime and amikacin
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Scientific title
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An open labelled post marketing surveillance study to evaluate safety and efficacy of a fixed dose combination of cefepime and amikacin in subjects with mild to severe infections
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Acronym
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N/A
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Serial number at source
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Nex/VR/CT_PMS_089/01_2007
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Study hypothesis
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To evaluate efficacy of fixed dose combination of cefepime-amikacin in various infections.
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Ethics approval
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Ethics approval received from:
1. Independent Ethic Committee for Clinical Research, New Delhi on the 11th April 2007 (ref: IEC/Nex/VR//CT-PMS/08901-2007)
2. Ethic Committee, SP Medical College and Associated Hospitals, Bikaner on the 16th July 2008 (ref: SP-EC//Nex/VR//CT-PMS/08901-2007)
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Study design
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Open labelled, 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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Nosocomial pneumonia, febrile neutropenia, other bacterial infections
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Participants - inclusion criteria
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1. Hospitalised patients of either sex
2. Above 18 years of age
3. Clinically diagnosed subjects with moderate to severe infections of:
3.1. Febrile neutropenia (n = 110)
3.2. Nosocomial pneumonia (n = 110)
3.3. Other bacterial infection (n = 91)
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Participants - exclusion criteria
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1. History of hypersensitivity reaction or any specific contraindication to penicillin group of drugs
2. Hepatic or renal disorder or any heart disorder
3. Pregnancy and/or lactation
4. History of hearing loss
5. Alcoholics
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Anticipated start date
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28/04/2007
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Anticipated end date
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14/09/2007
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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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315
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Interventions
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The subjects were divided in three groups as per the severity of the infection:
1. Group A (severely infected) were given 2.5 g twice daily (BD) of cefepime-amikacin fixed dose combination (FDC)
2. Group B (moderately infected) were given 1.25 g BD of cefepime-amikacin FDC
3. Group C (mildly infected) were given 0.625 g BD of cefepime-amikacin FDC
Total duration of therapy 3 - 10 days, followed up 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 and completion of treatment (COT) (i.e. day 5 - 7 or COT).
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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 and completion of treatment (COT) (i.e. day 5 - 7 or COT).
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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
Tanuraj
Sirohi
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Address
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Subharti Medical College
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City/town
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Merrut, UP
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Zip/Postcode
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250002
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Country
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India
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Email
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tsirohi@yahoo.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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