Role of oral penicillin prophylaxis in preventing serious infections in Sickle Cell Disease in children aged 3 months to 5 years: a randomised controlled trial
| ISRCTN | ISRCTN42938377 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42938377 |
| Secondary identifying numbers | 5/20/12/05 |
- Submission date
- 18/01/2008
- Registration date
- 12/09/2008
- Last edited
- 12/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
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 Archana Patel
Scientific
Scientific
Professor & Head
Department of Paediatrics
Indira Gandhi Government Medical College
Central Avenue Road
Nagpur
Maharashtra
440018
India
| Phone | +91 (0)712 277 0509 |
|---|---|
| ceuiggmc@yahoo.co.in |
Study information
| Study design | Double blind randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SCD |
| Study objectives | The null hypothesis is that in India, the rate of severe infection in children aged 3 months to 5 years of sickle cell anaemia receiving penicillin prophylaxis is not different from those who do not receive prophylaxis. |
| Ethics approval(s) | Ethics approval received from the Clinical Ethics Committee of Indira Gandhi Government Medical College, Nagpur on the 13th November 2006 (ref: I.G.G.M.C./Pharm/272/2006). |
| Health condition(s) or problem(s) studied | Sickle cell anaemia |
| Intervention | 1. Oral penicillin 125 mg twice a day for children below three years and 250 mg twice a day for older children up to 5 years 2. Placebo twice a day in the same doses as above as per age groups Most children above 2 years also received polyvalent pneumococcal vaccine. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Penicillin |
| Primary outcome measure | Severe infections. |
| Secondary outcome measures | 1. Mortality 2. Sickle cell crisis 3. Blood transfusion 4. Number of hospitalisation 5. Unwell days 6. Other infections |
| Overall study start date | 01/12/2006 |
| Completion date | 31/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 65 |
| Key inclusion criteria | 1. Age 3 months to 5 years, either sex 2. Homozygous sickle cell (HbSS) pattern of haemoglobin (Hb) on cellulose acetate electrophoresis 3. Subjects whose parents consent to participate |
| Key exclusion criteria | 1. Chronic illness other than sickle cell disease (SCD) 2. On long term medication other than vitamins and trace metals 3. Any known allergy to penicillin |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 31/10/2007 |
Locations
Countries of recruitment
- India
Study participating centre
Professor & Head
Maharashtra
440018
India
440018
India
Sponsor information
Indira Gandhi Government Medical College (India)
University/education
University/education
Dean
Central Avenue Road
Nagpur
Maharashtra
440018
India
| Website | http://www.igmcshimla.org/ |
|---|---|
"ROR" |
https://ror.org/011r34n61 |
Funders
Funder type
University/education
Indira Gandhi Government Medical College, Nagpur (India) - institutional funding (ref: 5/20/12/05)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
