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.
Conditions
Interventions
Product Name: Ivermectin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: PfSPZ
Pharmaceutical Form:
Concentratio
Sponsors
Universitaetsklinikum Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To assess whether ivermectin can inhibit the hepatic invasion and development of Plasmodium falciparum and provide partial malarial prophylaxis. ;Secondary Objective: Secondary Objectives: To assess a potential effect of ivermectin against Plasmodium blood stages ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Safety (and AE) Assessment method: clinical examination and laboratory analysis (see section 6 “assessment of safety” below) b) Mean parasite density at day 12 Assessment method: Quantitative PCR c) Mean parasite density at treatment Assessment method: Quantitative PCR d) Proportion of infected individuals at days 12-20 (infectivity) Assessment method: Thick smear e) Parasite multiplication rate and kinetics Assessment method: Quantitative PCR f) Estimation of infected liver cells by CHMI Assessment method: Quantitative PCR ;Timepoint(s) of evaluation of this end point: day 0 to day 90 after challenge infection | — |
Countries
Germany
Contacts
Public ContactInstitut fuer Tropenmedizin
Universitaetsklinikum Tuebingen
Outcome results
None listed