In this project, the possible effects of ivermectin on liver stages of Plasmodium falciparum will be evaluated with the help of controlled human malaria infections.
- Conditions
- In spite of remarkable progress over the last 15 years, malaria continues to be a major public health problem in the developing world with an estimated 214 million cases and 438.000 deaths in 2014. The enormous economic and social consequences of malaria have been well documented. By far the major burden is in Africa and the enormous economic and social consequences of malaria have been well documented.Therapeutic area: Diseases [C] - Parasitic Diseases [C03]
- Registration Number
- EUCTR2017-002723-16-DE
- Lead Sponsor
- niversitaetsklinikum Tuebingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Healthy adults aged 18 to 45 years
Body mass index 18 - 35
Able and willing (in the Investigator’s opinion) to comply with all study requirements
Residence in Tuebingen or surroundings for the period of the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
History of P. falciparum malaria
Travel to malaria endemic region before the participation in the study with positive P. falciparum serology at screening.
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective: To assess whether ivermectin can inhibit the hepatic invasion and development of Plasmodium falciparum and provide partial malarial prophylaxis.<br>;Secondary Objective: Secondary Objectives: To assess a potential effect of ivermectin against Plasmodium blood stages<br>;Primary end point(s): Time to microscopically detectable parasitaemia ;Timepoint(s) of evaluation of this end point: day 6 to day 21 after challenge infection
- Secondary Outcome Measures
Name Time Method Secondary end point(s): a)Safety (and AE)<br>Assessment method: clinical examination and laboratory analysis (see section 6 assessment of safety” below)<br>b)Mean parasite density at day 12 <br>Assessment method: Quantitative PCR<br>c)Mean parasite density at treatment <br>Assessment method: Quantitative PCR<br>d)Proportion of infected individuals at days 12-20 (infectivity)<br>Assessment method: Thick smear<br>e)Parasite multiplication rate and kinetics<br>Assessment method: Quantitative PCR<br>f)Estimation of infected liver cells by CHMI<br>Assessment method: Quantitative PCR<br>;Timepoint(s) of evaluation of this end point: day 0 to day 90 after challenge infection