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ISRCTN
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ISRCTN69844323
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ClinicalTrials.gov identifier
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Public title
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Ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory tract infections
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Scientific title
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Comparative efficacy and synergy establishment of ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory 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/ceftazidime_tobramycin/082006A
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Study hypothesis
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1. To assess efficacy of ceftazidime tobramycin fixed drug combination (FDC) in comparison with ceftazidime monotherapy in lower respiratory tract infections
2. To assess comparative safety of study drugs
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Ethics approval
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Ethics approval received from the National Ethic Committee, Ahemdabad on the 28th April 2007 (date of issue of letter: 2nd May 2007) (ref: NEC/04-2007/01/VENUS/TOBCEF/082006A).
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Study design
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Open labelled, comparative, 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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Lower respiratory tract infections
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Participants - inclusion criteria
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1. Participants aged greater than 18 years (n = 240), either sex
2. Hopsitalised patients suffering from lower respiratory tract infections
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Participants - exclusion criteria
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1. Patients having received antibiotic treatment within two weeks of therapy
2. History of hypersensitivity reaction or any specific contraindication to beta lactams
3. Presence of hepatic or renal disorders
4. Pregnancy or lactation
5. History of hearing loss
6. Alcoholics
7. 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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240
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Interventions
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1. Ceftazidime (1 g) and tobramycin (120 mg) fixed drug combination (FDC), eight-hourly, intravenous (i.v.) for seven days
2. Ceftazidime (1 g), eight-hourly, i.v. for seven days
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Primary outcome measure(s)
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Improvement in clinical and laboratory parameters, measured on day 0 and day 7, followed up to 10 days after the 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 and day 7, followed up to 10 days after the 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 - 1
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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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