Contact information
Type
Scientific
Primary contact
Dr Milind Khadke
ORCID ID
Contact details
Manas Chest Clinic
301 Marathon Chambers
P.K. Road
Paanchrasta
Mulund (W)
Mumbai
400022
India
milind_khadke@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CT/CS/01
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Independent institutional ethics committee approval of participating centres were taken before initiation, reference number: CT/CS/01
Study design
Open-label, non-comparative, multicentric study
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Lower respiratory tract infection
Intervention
Treatment consisted of 1 g ceftriaxone + 0.5 g sulbactam in intravenous fixed dose combination every eight hours for 7 -10 days
Intervention type
Drug
Phase
Not Specified
Drug names
Ceftriaxone, sulbactam
Primary outcome measures
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%).
Secondary outcome measures
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
Overall trial start date
01/04/2005
Overall trial end date
30/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age ≥18 years
2. Fever ≥38°C
3. Sputum pus cells >25 high power fields (HPF)
4. Buccal epithelial cells <10 HPF
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
105
Participant exclusion criteria
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
Recruitment start date
01/04/2005
Recruitment end date
30/09/2005
Locations
Countries of recruitment
India
Trial participating centre
Manas Chest Clinic
Mumbai
400022
India
Sponsor information
Organisation
Venus Remedies Limited (India)
Sponsor details
Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
Haryana
134113
India
+91 17 22561244
operations@venusremedies.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Venus Remedies Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary