Safety and efficacy of a fixed dose combination of cefepime and amikacin
| ISRCTN | ISRCTN61799591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61799591 |
| Protocol serial number | Nex/VR/CT_PMS_089/01_2007 |
| 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 Tanuraj Sirohi
Scientific
Scientific
Subharti Medical College
Merrut, UP
250002
India
| tsirohi@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open labelled, randomised, multicentric clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | An open labelled post marketing surveillance study to evaluate safety and efficacy of a fixed dose combination of cefepime and amikacin in subjects with mild to severe infections |
| Study objectives | To evaluate efficacy of fixed dose combination of cefepime-amikacin in various infections. |
| Ethics approval(s) | Ethics approval received from: 1. Independent Ethic Committee for Clinical Research, New Delhi on the 11th April 2007 (ref: IEC/Nex/VR//CT-PMS/08901-2007) 2. Ethic Committee, SP Medical College and Associated Hospitals, Bikaner on the 16th July 2008 (ref: SP-EC//Nex/VR//CT-PMS/08901-2007) |
| Health condition(s) or problem(s) studied | Nosocomial pneumonia, febrile neutropenia, other bacterial infections |
| Intervention | The subjects were divided in three groups as per the severity of the infection: 1. Group A (severely infected) were given 2.5 g twice daily (BD) of cefepime-amikacin fixed dose combination (FDC) 2. Group B (moderately infected) were given 1.25 g BD of cefepime-amikacin FDC 3. Group C (mildly infected) were given 0.625 g BD of cefepime-amikacin FDC Total duration of therapy 3 - 10 days, followed up for 7 days after the treatment. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cefepime-amikacin |
| Primary outcome measure(s) |
Improvement in clinical and laboratory parameters, measured on day 0 and completion of treatment (COT) (i.e. day 5 - 7 or COT). |
| Key secondary outcome measure(s) |
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0 and completion of treatment (COT) (i.e. day 5 - 7 or COT). |
| Completion date | 14/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 315 |
| Key inclusion criteria | 1. Hospitalised patients of either sex 2. Above 18 years of age 3. Clinically diagnosed subjects with moderate to severe infections of: 3.1. Febrile neutropenia (n = 110) 3.2. Nosocomial pneumonia (n = 110) 3.3. Other bacterial infection (n = 91) |
| Key exclusion criteria | 1. History of hypersensitivity reaction or any specific contraindication to penicillin group of drugs 2. Hepatic or renal disorder or any heart disorder 3. Pregnancy and/or lactation 4. History of hearing loss 5. Alcoholics |
| Date of first enrolment | 28/04/2007 |
| Date of final enrolment | 14/09/2007 |
Locations
Countries of recruitment
- India
Study participating centre
Subharti Medical College
Merrut, UP
250002
India
250002
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 |
