A Phase 1/2 interventional study of Proguanil and mefloquine plus artesunate in Malaria and Sickle Cell Crisis, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Nigeria. Open to participants aged 6 Months to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-21.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 1/2, Interventional, and Prevention
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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 270 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
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Exclusion Criteria:
Standard policy of a supply of proguanil tablets to be taken daily
Drug: Proguanil
Intermittent Preventive Treatment (IPT) consisting of a bimonthly course of treatment with mefloquine-artesunate (MQ+AS)
Drug: mefloquine plus artesunate
IPT with bimonthly course of treatment with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ)
Drug: Sulfadoxine-pyrimethamine plus amodiaquine
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).
Incidence of adverse events
Time frame: 12 months
Adherence to the recommended regimen
Time frame: 12 months
Efficacy against malaria
Time frame: 12 months
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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London School of Hygiene and Tropical Medicine