Efficacy and safety of the fixed dose combination of cefpirome and sulbactam
ISRCTN | ISRCTN42833283 |
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DOI | https://doi.org/10.1186/ISRCTN42833283 |
Secondary identifying numbers | venus/cefpirome_sulbactam/082006A |
- 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
Study design | Open labelled, non randomised, multicentric clinical trial |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Cefpirome, sulbactam |
Primary outcome measure | Improvement in clinical and laboratory parameters, measured at day 0, day 3 and day 7 (completion of treatment). |
Secondary outcome measures | 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). |
Overall study start date | 01/05/2007 |
Completion date | 31/07/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
Sponsor information
Venus Remedies Limited (India)
Industry
Industry
51 - 52 Industrial Area
Phase - I
Panchkula, Haryana
134113
India
research@venusremedies.com | |
Website | http://www.venusremedies.com |
https://ror.org/0169rv113 |
Funders
Funder type
Industry
Venus Remedies Limited (India)
No information available
Results and Publications
Intention to publish date | |
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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 |