Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection
ART-CT001
Clinical Assessment of the Safety and Efficacy of Artemisia Annua Infusion Preparation for the Treatment of Asymptomatic Plasmodium Falciparum Infection in Semi-immune Adults in Gabon
1 other identifier
interventional
20
1 country
1
Brief Summary
The goal of this clinical trial is to determine whether Artemisia annua dried leaves, used as an infusion, can treat individuals with malaria parasites but no symptoms. The main question it aims to answer is: Can Artemisia annua infusion be used to treat malaria? Researchers will compare those receiving Artemisia annua infusion with those receiving an infusion of Centaurii herba (which has no effect on malaria parasites) to see whether all individuals treated with Artemisia annua infusion are cured, which should not be the case for those receiving Centaurii herba infusion. Participants will
- drink Artemisia annua infusion over seven days (three days at our research centre and four days at their home
- visit the research centre once a week for three weeks after treatment for one month for safety reasons
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2026
CompletedFirst Submitted
Initial submission to the registry
September 9, 2026
CompletedFirst Posted
Study publicly available on registry
September 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
September 15, 2026
August 1, 2026
8 months
September 9, 2026
September 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants in whom the parasitaemia was cleared
No parasites detected in the thick blood smear (microscopic method)
On day 7 from the first day of treatment
Secondary Outcomes (2)
Number of participants cured
From the last day of treatment (day 7) to the end of the follow-up period on day 28
Number of adverse events
From the first day of treatment (enrolment) to the end of the treatment period on day 7
Study Arms (2)
Artemisia arm
EXPERIMENTALControl arm
PLACEBO COMPARATORInterventions
Dried Artemisia annua leaves will be used to prepare an infusion by adding 5 mg of dried leaves to 1 litre of boiled water. The mixture will be left to stand for 15 minutes, then stirred and strained before being administered to the participant. Participants will receive 1 litre of this infusion (prepared each morning) per day for seven consecutive days. The research team will administer the daily dose in three splits at 8-hour intervals.
The research team will prepare one litre of 'Herba Centaurii' infusion every morning, which will be given to the participants in three splits every 8 hours, under the supervision of the research team for seven consecutive days.
Eligibility Criteria
You may qualify if:
- Age: 18 to 45 years
- Absence of fever (body temperature \<37.5ºC axillary or \<38.0°C oral, rectal or tympanic temperature)
- Asymptomatic P. falciparum infection with parasitemia between 500 and 2,000 asexual P. falciparum parasites per μl of blood
- Have been living in an endemic area for at least 5 years.
- Written informed consent from the participant
- Residence in the vicinity of the study centre
- Willingness to comply with the follow-up schedule
You may not qualify if:
- History of fever over the last 72 hours
- Non-Plasmodium falciparum infection
- Intake of any antimalarial drug or antibiotic with antimalarial activity within the previous 28 days and/or after half-life time
- Presence of signs and symptoms related by the medical doctor to malaria
- Known history or evidence of clinically significant medical disorders
- Severe malnutrition
- Haemoglobin concentration \<7 g/dL
- Known hypersensitivity and contraindications to any study medication
- Pregnancy or lactation
- Participation in other interventional studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Recherches Médicales de Lambaréné
Lambaréné, Gabon, BP: 242, Gabon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steffen Borrmann, Prof.
Institut für Tropenmedizin, Universitätsklinikum Tübingen, Wilhelmstraße 27, 72074 Tübingen, Germany
- STUDY CHAIR
Ayôla Akim Adegnika, Prof.
Centre de Recherches Médicales de Lambaréné
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2026
First Posted
September 15, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
September 15, 2026
Record last verified: 2026-08