Addressing Asymptomatic Plasmodium Reservoirs to Accelerate Malaria Elimination and Eradication in Rwanda.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKing Faisal Hospital Rwanda

About this trial

The investigators believe that to effectively achieve malaria elimination in Rwanda, it is critical to target the human reservoirs of Plasmodium falciparum using local and readily available Artemisia tea. Asymptomatic infections detectable by PCR are important reservoirs because they often persist for months and harbor gametocytes, the parasite stage infectious to mosquitoes. Lessons learnt from this study will be of critical importance for health decision makers with regard to potential malaria control. MSc and PhD students will be trained and the impact of this research project will be enormous on the socioeconomic transformation of Rwanda.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Confirmed as asymptomatic reservoir of Plasmodium in the community or after completing standard malaria treatment.

Leave for at least one month in Rwanda for non-national

Be between 18 and 65 years of age, and in good general health.

Not taking any other malaria drug for prevention or treatment.

Disqualifiers

Have known hypersensitivity to any ingredients of the test treatment.

Have participated in any other malaria drug trial or device less than 14 days before.

History or presence of clinically significant medical, psychiatric, or emotional condition that would compromise the safety of the subject or adherence to the interventional requirements.

Be pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artemisia afra or Annua 10g oral infusion/tea per day for 14 days

    Dietary supplement

    Participants will be recruited after completing standard malaria treatment, and those who have a positive qRT-PCR for plasmodium gametocyte reservoirs will be randomly assigned to either artemisia afra tea, or artemisia annua tea or into the control group with no intervention

Treatment groups

125 Participants
are divided into 3 treatment groups
Group A: Artemisia AfraExperimental treatment 1 intervention
Group B: Artemisia AnnuaExperimental treatment 1 intervention
Group C: No treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Negative RT-PCR for plasmodium reservoirs

The primary outcome will be negative P. falciparum blood stage infection as detected by RT-qPCR (CT ≥ 40) after 14 days of Artemisia infusion treatment.

Time frame
14 days

Secondary outcomes

1

urea and creatinine

Kidney function test will be done on serum, to establish a baseline, and repeated at day 14 following completion of the treatment

Time frame
14 days
2

Liver enzymes; ALT/ AST

Baseline test of the liver transaminases will be done on serum, and repeated at day 14

Time frame
14 days
3

Urine dipstick

a urine dipstick will be done; PH, leucocytes, blood, nitrites, specific gravity, ketones, glucose, urobilinogen.

Time frame
14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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