Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali

Launched by LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE · Sep 21, 2022

Keywords

ClinConnect Summary

Full protocol available on request

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 10 years and ≤ 50 years
• • 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
• • Haemoglobin ≥ 10 g/dL
• • Individuals weighing \< = 80 kg
• • No evidence of acute severe or chronic disease
• • Written, informed consent
• Exclusion Criteria:
• • Women who are pregnant or lactating (tested at baseline). Urine and/or serum pregnancy testing (β-hCG) will be used.
• • Detection of a non-P. falciparum species by microscopy
• • Previous reaction to study drugs / known allergy to study drugs, such as sudden high fevers, shaking or severe sore throat or ulcers in the mouth during treatment with Amodiaquine
• • Current eye disease with retinal damage
• • Signs of severe malaria, including hyperparasitaemia (defined as asexual parasitaemia \> 100,000 parasites / µL)
• • Signs of acute or chronic illness, including hepatitis
• • The use of other medication (except for paracetamol and/or aspirin), including antacids, other medicines used to treat malaria, abnormal heart rhythm, depression or mental illness or HIV/AIDS, and medicines that have antibiotic/antifungal properties
• • 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 or HIV/AIDS, malignancy or conditions that may affect absorption of study medication e.g., severe diarrhoea 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 haematology values (laboratory guideline values for exclusion are haemoglobin \< 10 g/dL, platelets \< 50,000/μl, White Blood Cell count (WBC) \< 2000/μl, serum creatinine \>2.0mg/dL, or ALT more than 3 times the upper limit of normal for age.
• • Blood transfusion in the last 90 days.
• • Known Electrocardiogram (ECG) corrected QT interval of more than 450 ms
• • Documented or self-reported history of cardiac conduction problems
• • Documented or self-reported history of epileptic seizures