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ISRCTN
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ISRCTN51896330
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ClinicalTrials.gov identifier
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Public title
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Multicentric clinical trial on the efficacy and safety of ceftriaxone and sulbactam in lower respiratory tract infection
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Scientific title
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Acronym
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N/A
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Serial number at source
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CT/CS/01
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Study hypothesis
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The increasing rate of the resistance of antibacterials in lower respiratory tract infection (LRTI) pathogens has resulted in the need to consider innovative approaches like combining β-lactam antibiotics with β-lactamase inhibitors. The presence of sulbactam in fixed-dose combination (FDC) along with ceftriaxone could extend the antibiotic spectrum of ceftriaxone to include bacteria normally resistant to it. The aim of our study was to evaluate the efficacy and safety of ceftriaxone and sulbactam in fixed-dose combination in the treatment of lower respiratory tract infection.
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Lay summary
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Ethics approval
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Independent institutional ethics committee approval of participating centres were taken before initiation, reference number: CT/CS/01
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Study design
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Open-label, non-comparative, multicentric study
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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 infection
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Participants - inclusion criteria
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1. Age ≥18 years
2. Fever ≥38°C
3. Sputum pus cells >25 high power fields (HPF)
4. Buccal epithelial cells <10 HPF
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Participants - exclusion criteria
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1. Hypersensitivity to ceftriaxone, sulbactam or related drugs
2. Children less than 18 years of age
3. Septicemic shock, active pulmonary malignancies, renal and hepatic insufficiencies
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Anticipated start date
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01/04/2005
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Anticipated end date
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30/09/2005
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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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105
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Interventions
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Treatment consisted of 1 g ceftriaxone + 0.5 g sulbactam in intravenous fixed dose combination every eight hours for 7 -10 days
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Primary outcome measure(s)
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The overall efficacy of fixed dose combination (FDC) of ceftriaxone and sulbactam was excellent. The clinical cure rate was 77.14% and the bacteriological cure rate was 100%. A total of three adverse reactions were noted in 12 of the 105 patients receiving ceftriaxone and sulbactam (FDC) but none of them warranted discontinuation of treatment. Adverse effects noted included: pain at the injection site (5.7%), superficial thrombophlebitis (4.76%), and mild diarrhea (0.95%).
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Secondary outcome measure(s)
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Ceftriaxone and sulbactam in fixed dose combination (FDC) is an effective and well-tolerated antimicrobial agent that appears promising for the treatment of serious lower respiratory tract infections
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Sources of funding
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Venus Remedies Limited
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Trial website
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Publications
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Contact name
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Dr
Milind
Khadke
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Address
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Manas Chest Clinic
301 Marathon Chambers
P.K. Road
Paanchrasta
Mulund (W)
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City/town
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Mumbai
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Zip/Postcode
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400022
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Country
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India
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Email
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milind_khadke@yahoo.com
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Sponsor
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Venus Remedies Limited (India)
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Address
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Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
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City/town
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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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Tel
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+91 17 22561244
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Fax
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+91 17 22565566
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Email
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operations@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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08/06/2006
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Last edited
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23/06/2006
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Date ISRCTN assigned
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23/06/2006
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