Intermittent Preventive Treatment for Malaria in Patient With Sickle Cell Disease
Condition: Malaria; Sickle Cell Crisis
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): Proguanil; mefloquine plus artesunate; Sulfadoxine-pyrimethamine plus amodiaquine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Proguanil tablets, 1.5mg/kg/day; This treatment is given once a day for 3 days. Patients weighing 5-8 kg receive one paediatric tablet per day, those weighing 9-17 kg two paediatric tablets, those weighing 18-29 kg one adult tablet and those weighing 30 kg and two adult tablets.; amodiaquine plus sulfadoxine-pyrimethamine supervised at each bimonthly clinic visit (amodiaquine 10mg/kg per day for three days and sulfadoxine-pyrimethamine (25/1.25 mg/kg) on the first day).
Intervention MeSH terms: Artesunate; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine; Mefloquine; Proguanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sickle cell disease; Malaria; Intermittent Preventive Treatment (IPT); prophylaxis