Malaria
Conditions
Interventions
Sponsors
Centre de Recherches Medicales de Lambarene
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, aged = 18 years and body weight = 45 kg - P. falciparum parasitaemia of 200 to 5000 parasites/µL - Asymptomatic malaria defined as: presence of P. falciparum mono-infection with absence of fever (axillary temperature <38.5 °C and absence of history of fever in the recent 24 hours and the week before inclusion) and other symptoms re-lated to malaria - Willingness to take part in the study and to sign the informed consent form
Exclusion criteria
Exclusion criteria: - Active tuberculosis, or history of taking anti-tuberculosis medications within 12 months prior to screening - any Loa loa microfilaria infection detected by microscopy - AST/ALT > 2x the upper limit of normal range (ULN) - Taking an experimental drug in the last 4 weeks - Antimalarial treatment in the last 4 weeks - Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin) - Use of ivermectin within 30 days of study enrolment - Participants taking herbal medication within one week of screening - Known or suspected electrolyte imbalance, e.g. hypokalae-mia, hypocalcaemia or hypomagnesemia with clinical signif-icance - Moderate to severe anaemia (Haemoglobin level <8 g/dL) - Any known or suspected immunosuppressive or immunode-ficient condition, including human immunodeficiency virus (HIV) infection - Severe malnutrition (Body Mass Index (BMI) < 16.0) - Pregnant or nursing (lactating) women - Known chronic underlying disease such as sickle cell disease or severe cardiac impairment - Participants with serum creatinine = 2 X ULN in the absence of dehydration. In case of dehydration, Participants with se-rum creatinine = 2 X ULN after oral or parenteral rehydration - Participants with any psychiatric or neurological condition including substance abuse - Allergy to ivermectin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to 90% parasite reduction for at least 8 hours assessed by microscopy Number and occurrence of related SAE and Grade 3 AE from time of first administration of ivermectin until the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to 90% parasite reduction assessed by qPCR Difference in AUC of parasitaemia until D7 Parasite clearance time, defined as time to parasitaemia <100 parasites/mL Number and occurrence of any AE from time of first admin-istration of ivermectin until the end of the study | — |
Countries
Gabon
Contacts
Public ContactMichael Ramharter
Bernhard Nocht Institute for Tropical Medicine
Outcome results
None listed