Condition category
Haematological Disorders
Date applied
18/01/2008
Date assigned
12/09/2008
Last edited
12/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Archana Patel

ORCID ID

Contact details

Professor & Head
Department of Paediatrics
Indira Gandhi Government Medical College
Central Avenue Road
Nagpur
Maharashtra
440018
India
+91 (0)712 277 0509
ceuiggmc@yahoo.co.in

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5/20/12/05

Study information

Scientific title

Acronym

SCD

Study hypothesis

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

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).

Study design

Double blind randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Penicillin

Primary outcome measures

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 trial start date

01/12/2006

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

65

Participant 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

Recruitment start date

01/12/2006

Recruitment end date

31/10/2007

Locations

Countries of recruitment

India

Trial participating centre

Professor & Head
Maharashtra
440018
India

Sponsor information

Organisation

Indira Gandhi Government Medical College (India)

Sponsor details

Dean
Central Avenue Road
Nagpur
Maharashtra
440018
India

Sponsor type

University/education

Website

http://www.igmcshimla.org/

Funders

Funder type

University/education

Funder name

Indira Gandhi Government Medical College, Nagpur (India) - institutional funding (ref: 5/20/12/05)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes