During the multiple dose stage, participants received the standard dose of ivermectin 200 μg/kg once daily for one, two, or three days, respectively. In the randomized-controlled trial stage, participants received either ivermectin 300 μg/kg once daily for three days or placebo once daily for three days, based on dosage in a previous trial administering ivermectin to Plasmodium-infected participants.23 (link) The number of tablets for placebo-treated participants equalled the number of tablets for ivermectin-treated participants with identical body weight. Ivermectin and placebo were administered orally with water after intake of butter croissant. Tablets were concealed in neutral plastic bags so that participants were not able to distinguish ivermectin from placebo. Drug administration was done in a separate room by a pharmacy team member to maintain double blinding. The first dose was administered directly after successful eligibility assessment. Subsequent doses were given at the same time point ±30 min on the following two days, when applicable.
Placebo tablets were Winthrop's P-Tabletten Weiss 7 mm Lichtenstein, which do not contain any active ingredient. They were purchased at the University Pharmacy Tübingen, Germany. Ivermectin tablets were MSD's Stromectol 3 mg, purchased in Gabon. No quality analysis was performed on the drug batches used.
At enrolment, participants underwent physical examination with demographic data and medical history recorded. Blood samples were taken for haematology (red blood cell count, haemoglobin, haematocrit, leukocyte count with differential and platelet count), clinical chemistry (AST, ALT, urea, creatinine, CRP, and electrolytes), urinalysis, thick and thin blood smears, and for quantitative polymerase chain reaction (qPCR). Blood pregnancy tests were performed at baseline for female participants. Participants were hospitalized for 72 h. Following discharge from the research centre, participants returned for outpatient visits at days 4, 5, 6, and 7. Participants received rescue medication with artemether-lumefantrine (Novartis Coartem® 80/480) in case of fever (axillary temperature >38.5 °C) in conjunction with any Plasmodium parasitaemia or upon development of danger signs, or severe malaria, or parasitaemia ≥20,000 parasites/μl. All other participants were treated for malaria on day 7. Safety assessments were performed from first drug administration until end of study. These included daily physical examination, vital signs, and inquiry about adverse events (AEs), as well as clinical laboratory tests (haematology, clinical chemistry, urinalysis) upon screening and days 3, 5, and 7. AEs were followed up until resolution.
Placebo tablets were Winthrop's P-Tabletten Weiss 7 mm Lichtenstein, which do not contain any active ingredient. They were purchased at the University Pharmacy Tübingen, Germany. Ivermectin tablets were MSD's Stromectol 3 mg, purchased in Gabon. No quality analysis was performed on the drug batches used.
At enrolment, participants underwent physical examination with demographic data and medical history recorded. Blood samples were taken for haematology (red blood cell count, haemoglobin, haematocrit, leukocyte count with differential and platelet count), clinical chemistry (AST, ALT, urea, creatinine, CRP, and electrolytes), urinalysis, thick and thin blood smears, and for quantitative polymerase chain reaction (qPCR). Blood pregnancy tests were performed at baseline for female participants. Participants were hospitalized for 72 h. Following discharge from the research centre, participants returned for outpatient visits at days 4, 5, 6, and 7. Participants received rescue medication with artemether-lumefantrine (Novartis Coartem® 80/480) in case of fever (axillary temperature >38.5 °C) in conjunction with any Plasmodium parasitaemia or upon development of danger signs, or severe malaria, or parasitaemia ≥20,000 parasites/μl. All other participants were treated for malaria on day 7. Safety assessments were performed from first drug administration until end of study. These included daily physical examination, vital signs, and inquiry about adverse events (AEs), as well as clinical laboratory tests (haematology, clinical chemistry, urinalysis) upon screening and days 3, 5, and 7. AEs were followed up until resolution.
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