Intermittent Preventive Treatment for Malaria in Patient With Sickle Cell Disease
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
Medical Research Council Unit, The Gambia University of Ilorin Teaching Hospital Wellcome Trust
Treatments:
Amodiaquine Artesunate Fanasil, pyrimethamine drug combination Mefloquine Proguanil Pyrimethamine Sulfadoxine