Malaria Infections and Infestations Malaria
Conditions
Interventions
This trial compares three therapies for uncomplicated malaria, conducted at three locations in the city of Bobo-Dioulasso, Burkina Faso. The design will closely follow two studies that we conducted in
Sponsors
Institut de Recherche en Science de la Sante (IRSS) (Burkina Faso)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 6 months and above 2. Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours 3. Absence of any history of serious side effects to study medications, including allergy to sulfa drugs 4. No evidence of a concomitant febrile illness in addition to malaria 5. Provision of informed consent and ability to participate in 42-day follow-up (patient has easy access to health unit) 6. No history of treatment with any antimalarial (other than chloroquine) in the past 2 weeks. 7. No danger signs or evidence of severe malaria defined as: 7.1 Unarousable coma (if after convulsion, > 30 min) 7.2 Repeated convulsions (> 2 within 24 h) 7.3 Recent convulsions (1-2 within 24 h) 7.4 Altered consciousness (confusion, delirium, psychosis, coma) 7.5 Lethargy 7.6 Unable to drink or breast feed 7.7 Vomiting everything 7.8 Unable to stand/sit due to weakness 7.9 Severe anemia (hemoglobin 2000/ul and 5.0 g/dL
Exclusion criteria
Exclusion criteria: 1. Signs of severe malaria/danger signs 2. Known Allergy to the study medications 3. Inability to participate in 42 days follow up 4. Concommittant febrile illness 5. Severe anemia < 5g/dL 6. Absence of provision of informed and signed consent 7. Previous antimalarial use (other than chloroquine [CQ]) in the previous 14 days 8. Mixed infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes will be based on the risk of clinical and parasitological treatment failure after 28 days of follow-up either adjusted or unadjusted | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Risk of clinical failure after 14 days of follow-up 2. Risk of rescue therapy after 42 days of follow-up 3. Risk of fever during the first 3 days of follow-up: presence or absence of objective fever (axillary temperature > 37.5°C) or patient report of fever on days 1, 2, 3 4. Risk of parasitemia on follow-up days 2 and 3: proportion of positive vs. negative thick blood smears on day 2 and day 3 5. Change in mean hemoglobin from day 0 to 42 or day of repeat therapy 6. Proportion gametocytemic: presence vs. absence of gametocytes on any follow-up thick blood smear; proportion gametocytemic on days 2, 3, 7, 14, 21, 28, 35 and 42 7. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 42-day follow-up period, excluding treatment failures 8. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures | — |
Countries
Burkina Faso
Outcome results
None listed