Malaria Sickle cell anemia and febrile illnesses
Conditions
Interventions
Dihydroartemisinin piperaquine plus sulfadoxine pyrimethamine
Sponsors
Thrasher Research Fund
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Residence within Busia district or Tororo districts 2) Hemoglobin SS genotype by hemoglobin electrophoresis 3) Age between 2-10 years 4) Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol where possible 5) Provision of informed consent from parent/guardian and assent if children are =8 years of age
Exclusion criteria
Exclusion criteria: 1) HIV infected 2) Planning to leave the study area during the study period. 3) History of allergy or serious drug reaction to SP or DP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of all-cause febrile illnesses defined as an incident episode of subjective fever in the past 24 hours or axillary temperature >37.5°C.;Incidence of any grade 3-4 adverse events or serious adverse events ;Prevalence of resistance markers of high-grade antifolate resistance (Pfdhfr 164L and fdhps 581G). | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of documented fever, defined as all clinic visits during the follow-up period with an incident episode of axillary temperature >37.5°C.;Incidence of symptomatic malaria defined as a new episode of fever plus a positive blood smear not preceded by another episode in the last 14 days.;Incidence of pneumonia;Incidence of all-cause hospitalizations;Incidence of blood transfusions;Incidence of all-cause sick visits;Incidence of sickle cell crises;Incidence of all-cause deaths;Prevalence of malaria parasitemia;Prevalence of moderate-severe anemia defined as hemoglobin level less than 8g/dL;Incidence of individual grade 3-4 adverse events;Incidence of adverse events related to study drugs;Incidence of individual adverse events of any severity;Prevalence of observed or reported vomiting following administration of study drugs;Measures of non-adherence with study drugs defined as the proportion of study drug doses to be administered at home reported not taken.;Prevalence of DP resistance: PfK13 561H, 469Y, 675V and/or PfCRT 76T. | — |
Countries
Uganda
Contacts
Public ContactAmanda Atukunda
Communications coordinator
Outcome results
None listed