Efficacy and safety of the fixed dose combination of cefepime and sulbactam
| ISRCTN | ISRCTN84455313 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84455313 |
| Protocol serial number | venus/cefepime_sulbactam/082006A |
| Sponsor | Venus Remedies Limited (India) |
| Funder | Venus Remedies Limited (India) |
- Submission date
- 04/03/2008
- Registration date
- 15/05/2008
- Last edited
- 15/05/2008
- 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 Nitin Rathod
Scientific
Scientific
Dr R N Cooper Municipal General Hospital
Ville Parle
Mumbai
400056
India
| drnmrathod@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open labelled, non-randomised, multicentric clinical trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | Multicentric, open labelled, non-randomised, clinical trial to assess efficacy and safety of the fixed dose combination of cefepime and sulbactam in complicated upper and lower tract infections |
| Study objectives | The objectives were: 1. To study the efficacy of fixed dose combination of cefepime and sulbactam injections in in complicated upper and lower tract infections 2. To assess comaprative safety of study drug |
| Ethics approval(s) | Ethics approval received from the National Ethic Committee, Ahembdabad on the 28th April 2007 (date of issue of letter: 2nd May 2007) (ref: NEC/04-2007/02/VENUS/CEFEPIME_SULBACTAM/082006A). |
| Health condition(s) or problem(s) studied | Complicated upper and lower tract infections |
| Intervention | Fixed dose combination of cefepime and sulbactam (1.5 g to 3 g, intravenous [i.v.] twice daily). Duration of treatment 7 to 10 days, followed for 7 days after the treatment. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cefepime, sulbactam |
| Primary outcome measure(s) |
Improvement in clinical and laboratory parameters, measured on day 0, day 3 and day 7 (completion of treatment). |
| Key secondary outcome measure(s) |
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0, day 3 and day 7 (completion of treatment). |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 102 |
| Key inclusion criteria | 1. Participants aged greater than 18 years (n = 102), either sex 2. Suffering from lower respiratory tract infections caused by gram negative organisms including pseudomonas aeruginosa |
| Key exclusion criteria | 1. History of hypersensitivity reaction or any specific contraindication to beta lactams 2. Presence of hepatic or renal disorders 3. Pregnancy or lactation 4. History of hearing loss 5. Alcoholics 6. Previous history seizure |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- India
Study participating centre
Dr R N Cooper Municipal General Hospital
Mumbai
400056
India
400056
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 |
