The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy: a Longitudinal Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and asymptomatically infected individuals. Participants are treated with conventional artemisinin-combination therapies (ACT) as part of standard clinical care. From this population, we will select P. falciparum gametocyte carriers. Before, during and after ACT treatment, the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy, molecular methods, parasite culture and mosquito feeding assays. Parasite clearance will be determined in the first days (d0-3) after treatment. The study population will consist of passively recruited patients with uncomplicated P. falciparum malaria and asymptomatically infected individuals who are microscopy positive for gametocytes. Participants will be treated with conventional therapies for uncomplicated malaria without randomization: artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA-PPQ). All doses are supervised. Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment. Gametocyte carriage and gametocyte commitment/production will be determined for resistant and wild type infections before, during and after treatment. In addition, venous blood will be collected at three timepoints to assess transmission to mosquitoes before (d0), during (d2) and after treatment (d7). The total duration of participation will be 7 days, the primary endpoint will be the reduction in mosquito infection rates at d2 (artemether-lumefantrine) or d7 (dihydroartemisinin-piperaquine) compared to pre-treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• age ≥2 years

• blood smear positive for P. falciparum gametocytes

• mono-infection with P. falciparum confirmed by positive blood smear;

• parasitaemia of \>100 P. falciparum asexual forms/µL;

• ability to swallow oral medication;

• ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;

• informed consent from parent or guardian;

• haemoglobin ≥ 7.0 g/dl for children below 10 years of age or ≥8.0g/dL for older individuals

Locations
Other Locations
Uganda
Dr. Ambrosoli Memorial Hospital
RECRUITING
Kalongo
Patongo Health Facility IV
RECRUITING
Patongo
Contact Information
Primary
Emmanuel Arinaitwe, PhD
earinaitwe@idrc-uganda.org
+256 752900078
Backup
Teun Bousema, PhD
teun.bousema@radboudumc.nl
+31612198451
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2026-04
Participants
Target number of participants: 120
Treatments
Active_comparator: artemether-lumefantrine
artemether-lumefantrine according to manufacturer instructions
Experimental: dihydroartemisinin-piperaquine
dihydroartemisinin-piperaquine according to manufacturer instructions
Related Therapeutic Areas
Sponsors
Collaborators: London School of Hygiene and Tropical Medicine, Radboud University Medical Center
Leads: Infectious Diseases Research Collaboration, Uganda

This content was sourced from clinicaltrials.gov

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