To compare the response of children with sickle cell disease (SCD) and malaria to artemisinin combination therapy (ACT) antimalarials and the response of children without SCD treated with ACT for malaria
Completed
- Conditions
- Sickle cell disease/malariaInfections and InfestationsPlasmodium falciparum malaria
- Registration Number
- ISRCTN96891086
- Lead Sponsor
- Danida Fellowship Centre (Denmark)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. Children with SCD
2. Aged 6 months to 12 years
3. With acute P. falciparum malaria of parasite density < 200,000/µl
4. Consent obtained and willingness by parent or guardian to comply with the follow-up schedule
Exclusion Criteria
1. Symptoms or signs of severe malaria requiring parenteral treatment
2. Weight less than 5 kg
3. Presence of danger signs of malaria
4. Known intolerance or allergy to study medications
5. Reported treatment with any of the study drugs one month preceding enrolment
6. Blood transfusion preceding 3 months before enrolment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Parasite clearance rates in the initial 48 hours of treatment: survival analysis<br>2. Parasite reduction ratio on days 1, 2, and 3: the ratio of the parasite count before treatment to the parasite count on days 1, 2, and 3
- Secondary Outcome Measures
Name Time Method 1. Cure rates as determined by PCR-corrected adequate clinical and parasitological response (ACPR): the proportion of patients with ACPR on days 28 and 42<br>2. Parasitological response on days 28 and 42: any recurrence of parasitaemia after initial clearance till day 28 or 42<br>3. Changes in haematological profiles during the follow-up period: changes from baseline (day 0) in the following parameters: haemoglobin (Hb), total white blood cell count (WBC), absolute neutrophil count (ANC) and platelet counts (PLT) on days 3, 7, 28, and 42<br>4. Incidence of adverse events: incidence of new or treatment-emergent adverse events on days 3, 7, 28 and 42