Efficacy and safety of the fixed dose combination of cefpirome and sulbactam
| ISRCTN | ISRCTN42833283 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42833283 |
| Protocol serial number | venus/cefpirome_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 cefpirome and sulbactam in bacteraemia/septicaemia and severe infections in intensive care patients |
| Study objectives | The objective of the trial was to study the efficacy of fixed dose combination of cefpirome and sulbactam injections in bacteraemia/septicaemia and severe infections in intensive care patients. |
| 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/04-2007/04/VENUS/CEFPIROME_SULBACTAM/082006A). |
| Health condition(s) or problem(s) studied | Bacteraemia/septicaemia and severe infections |
| Intervention | Fixed dose combination of cefpirome 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) | Cefpirome, sulbactam |
| Primary outcome measure(s) |
Improvement in clinical and laboratory parameters, measured at 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 at 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 | 103 |
| Key inclusion criteria | 1. Participants aged greater than 18 years (n = 103), either sex 2. Suffering from bacteraemia/septicaemia and severe infections |
| 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 |
