Multicentric clinical trial on the efficacy and safety of ceftriaxone and sulbactam in lower respiratory tract infection
| ISRCTN | ISRCTN51896330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51896330 |
| Secondary identifying numbers | CT/CS/01 |
- Submission date
- 08/06/2006
- Registration date
- 23/06/2006
- Last edited
- 23/06/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Milind Khadke
Scientific
Scientific
Manas Chest Clinic
301 Marathon Chambers
P.K. Road
Paanchrasta
Mulund (W)
Mumbai
400022
India
| milind_khadke@yahoo.com |
Study information
| Study design | Open-label, non-comparative, multicentric study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Independent institutional ethics committee approval of participating centres were taken before initiation, reference number: CT/CS/01 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ceftriaxone, sulbactam |
| Primary outcome measure | 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 study start date | 01/04/2005 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 105 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- India
Study participating centre
Manas Chest Clinic
Mumbai
400022
India
400022
India
Sponsor information
Venus Remedies Limited (India)
Industry
Industry
Intellectual Scientific Division
Research and Development Centre
51-52 Industrial Area
Phase-1
Panchkula
Haryana
134113
India
| Phone | +91 17 22561244 |
|---|---|
| operations@venusremedies.com | |
| Website | http://www.venusremedies.com |
"ROR" |
https://ror.org/0169rv113 |
Funders
Funder type
Industry
Venus Remedies Limited
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
