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 |
| Protocol serial number | CT/CS/01 |
| Sponsor | Venus Remedies Limited (India) |
| Funder | Venus Remedies Limited |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Manas Chest Clinic
301 Marathon Chambers
P.K. Road
Paanchrasta
Mulund (W)
Mumbai
400022
India
| milind_khadke@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label, non-comparative, multicentric study |
| Secondary study design | Multi-centre |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ceftriaxone, sulbactam |
| Primary outcome measure(s) |
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%). |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
400022
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
