Intermittent Preventive Treatment for Malaria in Patient With Sickle Cell Disease
- Conditions
- MalariaSickle Cell Crisis
- Interventions
- Registration Number
- NCT01319448
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- Brief Summary
Malaria prophylaxis is recommended for sickle cell disease patients. In Nigeria, daily proguanil or weekly pyrimethamine are the most commonly prescribed regimens, but the current policy is not effective due to poor compliance and drug resistance. Intermittent treatment with a long acting drug regimen administered under supervision at clinic visits may be more effective. The aim of this trial is to compare the tolerability and acceptability of supervised bimonthly treatment with either sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) or mefloquine plus artesunate (MQ+AS), with the daily proguanil. Two hundred and seventy patients with sickle cell disease attending the paediatric sickle cell disease clinic in Ilorin hospital who meet the eligibility criteria and have parental consent, will be randomized to one of three prophylactic regimens: daily proguanil, bimonthly sulfadoxine-pyrimethamine plus amodiaquine, or bimonthly mefloquine plus artesunate. Patients will be asked to return to clinic every two months and whenever they are sick. At enrollment, the study paediatrician will conduct a physical examination of the child, and collect a venous blood sample for a complete blood cell count and biochemical screen, determination of G6PD genotype, preparation of blood smears for malaria microscopy and a blood spot for determination of molecular markers of resistance. Four days after each clinic visit, patients will be interviewed (by phone and, for a subset, at home or in the clinic) to ask about compliance and adverse events. Participants will be followed for one year. The parents or carer will be encouraged to bring their child to the Outpatient Department clinic if the child becomes unwell. The primary outcome of the trial is tolerability, secondary outcomes are adherence to the regimen, and incidence of malaria and the number of hospitalizations over 12 months. If the bimonthly regimens are well tolerated and the preliminary data from this study are promising, a larger multicentre trial will be required to determine efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- Age 6months or older and >=5kg
- Sickle cell clinic attendant
- Both males and females
- Agree to abide by the study protocol
- Give informed consent and assent
- Not acutely sick at the time of recruitment
- Not having additional chronic disease
- Hb genotype of SS and SC confirmed by electrophoresis
- known allergy to any of the antimalarial drugs use in the trial,
- severe illnesses requiring urgent admission,
- treatment with sulfadoxine-pyrimethamine or mefloquine in the previous 2wks
- patients on cotrimoxazole prophylaxis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daily proguanil Proguanil Standard policy of a supply of proguanil tablets to be taken daily IPT with MQ+AS bimonthly mefloquine plus artesunate Intermittent Preventive Treatment (IPT) consisting of a bimonthly course of treatment with mefloquine-artesunate (MQ+AS) IPT with SP+AQ bimonthly Sulfadoxine-pyrimethamine plus amodiaquine IPT with bimonthly course of treatment with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ)
- Primary Outcome Measures
Name Time Method Incidence of adverse events 12 months Adherence to the recommended regimen 12 months
- Secondary Outcome Measures
Name Time Method Efficacy against malaria 12 months
Trial Locations
- Locations (1)
Department of Paediatrics and Child Health, University of Ilorin Teaching Hospital
🇳🇬Ilorin, Kwara, Nigeria