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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42938377

Enrollment

Registered

2008-09-12

Start date

2006-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle cell anaemia Haematological Disorders Sickle-cell disorders

Interventions

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 c

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Severe infections.	—

Secondary

Measure	Time frame
1. Mortality 2. Sickle cell crisis 3. Blood transfusion 4. Number of hospitalisation 5. Unwell days 6. Other infections	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026