Malaria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients to be included in this study will comprise: Male and females between the ages of 18-65 years. Such patients should also have a fever, defined as >37.5ºC, during the current illness, or history (within the last 48 hours) of fever. They should also have been diagnosed with malaria defined as blood parasitemia = 200 parasites/µl. Participants should be able to communicate well with the investigator, comply with the requirements of the entire study, willing and/or able to return for a follow up and provide a written informed consent to participate as shown by a signature or thumbprint on the informed consent form.
Exclusion criteria
Exclusion criteria: Patients accessed by the clinician to be at risk of developing severe malaria or those with the signs and symptoms including but not limited to: impaired consciousness or unrousable coma, prostration, i.e. generalized weakness so that the patient is unable walk or sit up without assistance, failure to feed, multiple convulsions, deep breathing, respiratory distress (acidotic breathing), circulatory collapse or shock, systolic blood pressure < 70 mm Hg in adults and < 50 mm Hg in children and clinical jaundice plus evidence of other vital organ dysfunction will all be excluded from the study. Also, to be excluded are pregnant and lactating mothers, infants and newborns. Individuals with chronic diseases of the liver, renal system, as well as those who are on any antimalarials or have done so within the last 2 weeks will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary measure of efficacy of the treatments will be the total clearance of parasites by Day 5 after initiation of treatment. Participants who attain this outcome will be considered as having achieved a Complete cure. A definition of Partial efficacy will be applied when subjects are able to clear more than 75.0 % of initial parasite count by Day 5. Treatment failure will be said to have occurred when less than 75.0 % of the parasites have been cleared by Day 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other outcomes of interest will be the time taken for subject to attain the primary outcome (complete cure). Also, the response of fever to the treatments administered and the general improvement in related signs and symptoms will be measured. The absence of any untoward effects on the bodily organs as well as side effects (safety evaluation) will be considered as a secondary outcome. | — |
Countries
Ghana
Contacts
Dean School of pharmacy