Ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory tract infections
| ISRCTN | ISRCTN69844323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69844323 |
| Protocol serial number | venus/ceftazidime_tobramycin/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, comparative, randomised, multicentric clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Comparative efficacy and synergy establishment of ceftazidime tobramycin fixed drug combination (FDC) versus ceftazidime in lower respiratory tract infections |
| Study objectives | 1. To assess efficacy of ceftazidime tobramycin fixed drug combination (FDC) in comparison with ceftazidime monotherapy in lower respiratory tract infections 2. To assess comparative safety of study drugs |
| Ethics approval(s) | Ethics approval received from the National Ethic Committee, Ahemdabad on the 28th April 2007 (date of issue of letter: 2nd May 2007) (ref: NEC/04-2007/01/VENUS/TOBCEF/082006A). |
| Health condition(s) or problem(s) studied | Lower respiratory tract infections |
| Intervention | 1. Ceftazidime (1 g) and tobramycin (120 mg) fixed drug combination (FDC), eight-hourly, intravenous (i.v.) for seven days 2. Ceftazidime (1 g), eight-hourly, i.v. for seven days |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ceftazidime tobramycin fixed drug combination (FDC), ceftazidime alone |
| Primary outcome measure(s) |
Improvement in clinical and laboratory parameters, measured on day 0 and day 7, followed up to 10 days after the treatment. |
| Key secondary outcome measure(s) |
To observe incidence of adverse events as assessed by clinical evaluation and laboratory parameters, measured on day 0 and day 7, followed up to 10 days after the 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 | 240 |
| Key inclusion criteria | 1. Participants aged greater than 18 years (n = 240), either sex 2. Hopsitalised patients suffering from lower respiratory tract infections |
| Key exclusion criteria | 1. Patients having received antibiotic treatment within two weeks of therapy 2. History of hypersensitivity reaction or any specific contraindication to beta lactams 3. Presence of hepatic or renal disorders 4. Pregnancy or lactation 5. History of hearing loss 6. Alcoholics 7. 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 |
