Efficacy and safety of Ivermectin for the treatment of Plasmodium falciparum infections in asymptomatic Gabonese adults

Phase 1

• Conditions: Malaria

• Registration Number: PACTR201908520097051
• Lead Sponsor: Centre de Recherches Medicales de Lambarene

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 49

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

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified