NCT05801198

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
8mo left

Started Mar 2024

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

March 1, 2023

Last Update Submit

October 14, 2023

Conditions

Malaria,Falciparum

Outcome Measures

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.

    14 days

Secondary Outcomes (3)

  • urea and creatinine

    14 days

  • Liver enzymes; ALT/ AST

    14 days

  • Urine dipstick

    14 days

Study Arms (3)

Artemisia Afra

EXPERIMENTAL

artemisia afra 10g/ day for 14 days

Dietary Supplement: Artemisia afra or Annua 10g oral infusion/tea per day for 14 days

Artemisia Annua

EXPERIMENTAL

artemisia annua 10g/ day for 14 days

Dietary Supplement: Artemisia afra or Annua 10g oral infusion/tea per day for 14 days

No treatment

NO INTERVENTION

Interventions

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

Artemisia AfraArtemisia Annua

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Children 5 years and above will be recruited as index cases for household cluster survey.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Central Study Contacts

Edgar Kalimba, MD

CONTACT

+250788531514Edgar.mk@kfhkigali.com

Jacob SOUOPGUI, PhD

CONTACT

+32486080102Jacob.souopgui@ulb.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

April 6, 2023

Study Start

March 1, 2024

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

By publication in relevant scientific journals

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
36 months
Access Criteria
Authorization will be provided by study sponsors