MedTrace Logo

Experimental Falciparum Transmission to Anopheles

NCT02431637 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-05-26

Study results available
· View outcomes & findings →

Summary

This is a single-centre, open-label study using P. falciparum-induced blood stage malaria (IBSM) infection to assess the infectivity of sexual life cycle stages of the malaria parasite (gametocytes) to mosquito vectors. Previous clinical studies have shown that treatment of participants with the antimalarial drug piperaquine, in addition to effectively clearing asexual (pathogenic) stages of the malaria life cycle, induces the production of gametocytes in the blood. The propensity of piperaquine to induce gametocytemia will be employed in this study to assess gametocyte infectivity to Anopheles mosquitoes. For this purpose, experimental mosquito feeding directly on participants and artificial membrane mosquito feeding will be performed. The study will be conducted in 3 cohorts (n=2 per cohort). Subsequent cohorts will not commence until at least after day 28 of the previous cohort and review by Safety Review Team. This interval will also allow cohorting of experimental infection of mosquitoes to optimise logistics and enable iterative improvements in the system if applicable.

Conditions

Interventions

BIOLOGICAL

Administration of the malaria inoculum

Each participant in the cohort will be inoculated on Day 0 with \~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL.

DRUG

Piperaquine Phosphate 480 mg

When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate

Sponsors & Collaborators

  • Q-Pharm Pty Limited

    collaborator INDUSTRY

  • Clinical Network Services (CNS) Pty Ltd

    collaborator INDUSTRY

  • Sullivan Nicolaides Pathology

    collaborator INDUSTRY

  • QIMR Berghofer Medical Research Institute

    collaborator OTHER

  • Army Malaria Institute, Australia

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • James McCarthy, Prof · QIMR Berghofer Medical Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431637 on ClinicalTrials.gov