Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali
- Conditions
- Malaria
- Registration Number
- NL-OMON23822
- Lead Sponsor
- ondon School of Hygiene and Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Age = 10 years and = 50 years
- G6PD-normal defined by Carestart rapid diagnostic test or the OSMMR2000 G6PD qualitative test
- Absence of symptomatic falciparum malaria, defined by fever on enrolment
- Presence of P. falciparum gametocytes on thick blood film at a density >16 gametocytes/µL (i.e. = gametocytes recorded in the thick film against 500 white blood cells)
- Absence of other non-P. falciparum species on blood film
- Hemoglobin = 10 g/dL
- Individuals weighing < = 80 kg
- No evidence of acute severe or chronic disease
- Written, informed consent
- Women who are pregnant or lactating (tested at baseline). Urine and/or serum pregnancy testing (ß-hCG) will be used.
- Detection of a non-P. falciparum species by microscopy
- Previous reaction to study drugs / known allergy to study drugs
- Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia > 100,000 parasites / µL)
- Signs of acute or chronic illness, including hepatitis
- The use of other medication (except for paracetamol and/or aspirin)
- Use of antimalarial drugs over the past 7 days (as reported by the participant)
- Clinically significant illness (intercurrent illness e.g., pneumonia, pre-existing condition e.g., renal disease, malignancy or conditions that may affect absorption of study medication e.g., severe diarrhea or any signs of malnutrition as defined clinically)
- Signs of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e., decompensated cirrhosis, Child Pugh stage B or C)
- Signs, symptoms or known renal impairment
- Clinically significant abnormal laboratory values as determined by history, physical examination or routine blood chemistries and hematology values (laboratory guideline values for exclusion are hemoglobin < 10 g/dL, platelets < 50,000/µl, White Blood - Cell count (WBC) < 2000/µl, serum creatinine >2.0mg/dL, or ALT or AST more than 3 times the upper limit of normal for age.
- Blood transfusion in the last 90 days.
- Consistent with the long half-life of tafenoquine, effective contraception should be continued for 5 half-lives (3 months) after the end of treatment.
- History of psychiatric disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in mosquito infection rate assessed through membrane feeding assays (day 2 and day 7)<br>Within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline (day 0, pre-treatment) to day 2 post treatment in the AL and AL-PQ arms, and day 7 post-treatment in the SPAQ and SPAQ-TQ.<br><br>[Time Frame: 3 days (days 0, 2 and 7): 7 day span]
- Secondary Outcome Measures
Name Time Method