Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02511353
• Date of registration: 15/07/2015
• Prospective Registration: No
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study IVERMAL
• Scientific title: Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study (IVERMAL)
• Date of first enrolment: July 2015
• Target sample size: 141
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02511353
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Kenya

Contacts

• Name: Feiko ter Kuile, Prof.
• Affiliation: Liverpool School of Tropical Medicine

• Name: Menno R. Smit, MD, MPH
• Affiliation: Liverpool School of Tropical Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Symptomatic, uncomplicated Plasmodium falciparum infection

- Positive malaria microscopy or malaria RDT (pLDH)

- Age: 18-50 years

- Provide written informed consent

- Agree to be able to travel to clinic on days: 1, 2, 7, 10, 14, 21, and 28

Exclusion Criteria:

- Signs or symptoms of severe malaria

- Unable to provide written informed consent

- For women: pregnancy or lactation

- Hypersensitivity to ivermectin or DP

- QTc >460 ms on ECG

- Body Mass Index (BMI) below 16 or above 32 kg/m2

- Haemoglobin concentration below 9 g/dL

- Taken ivermectin in the last month

- Taken dihydroartemisinin-piperaquine in the last 12 weeks

- Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African
Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan

- History and/or symptoms indicating chronic illness

- Current use of tuberculosis or anti-retroviral medication

- Previously enrolled in the same study



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: placebo

Drug: dihydroartemisinin-piperaquine

Drug: ivermectin

Primary Outcome(s)

Mosquito survival [Time Frame: Survival of mosquitoes at 14 days after feeding on blood taking from study participants who started the 3-day ivermectin and DP regimen 7 days earlier.]

Secondary Outcome(s)

Mosquito survival [Time Frame: Survival of mosquitoes at each day up to day 21 or 28 after each feeding experiments performed at 0, 2 day+4h, 10, 14, 21, 28 days after start of treatment.]

Number of patients with malaria clinical and parasitological treatment response [Time Frame: Up to day 28.]

Peak plasma Concentration (Cmax) of ivermectin [Time Frame: Up to day 28.]

Area under the plasma concentration versus time curve (AUC) of piperaquine [Time Frame: Up to day 28.]

Tolerability as assessed by adverse events reported in a general toxicity questionnaire [Time Frame: Up to day 28.]

Peak plasma Concentration (Cmax) of piperaquine [Time Frame: Up to day 28.]

Mydriasis quantitated by pupillometry [Time Frame: Up to day 28.]

QTc interval [Time Frame: At 52 hours.]

Area under the plasma concentration versus time curve (AUC) of ivermectin [Time Frame: Up to day 28.]

CNS adverse events [Time Frame: Up to day 28.]

Serious adverse events [Time Frame: Up to day 28.]

Haemoglobin concentrations [Time Frame: Up to day 28.]

Secondary ID(s)

2775

14.002

6720

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kenya Medical Research Institute

Centers for Disease Control and Prevention