Asymptomatic P.Falciparum MalariaPhase 1ART-CT001NCT07819825
Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection
A Phase 1 study testing Artemisia Annua Leaf and Centaurii herba in people with Asymptomatic P.Falciparum Malaria, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asymptomatic P.Falciparum Malaria
- What is being tested?
- Artemisia Annua Leaf and Centaurii herba
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGabon
- Study dates
- 1 Sep 2026to Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Haemoglobin concentration <7 g/dL
- Known hypersensitivity and contraindications to any study medication
- Pregnancy or lactation
- Participation in other interventional studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gabon1 site
Centre de Recherches Médicales de Lambaréné
Lambaréné, Gabon, BP: 242
Jean Claude Dejon Agobé, MD, PhD, 0024177989191, jcagobe@cermel.org
Christian Chassem Lapue, MD, 0024177989191, christian.chassem@cermel.org
About this study
Official title: 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
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?
Read more
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
Read the detailed description
For safety reasons, participants will be followed up daily for malaria-like symptoms and parasite counts until the end of treatment. Indeed, if they are not free of parasites after seven days of treatment, they will receive rescue treatment, which is the WHO-recommended malaria treatment.
Similarly, if the number of parasites in their blood increases or they develop malaria-like symptoms during treatment, they will receive rescue treatment.
- Conditions
- Asymptomatic P.Falciparum Malaria
- Being tested
- Artemisia Annua Leaf, Centaurii herba
- Keywords
- Plasmodium falciparum, Artemisia annua, infusion
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemisia Annua LeafDrug
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.
Centaurii herbaDrug
Also called Centaurium erythrea
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.
| Study group | Role | What they receive |
|---|---|---|
| Artemisia arm | Experimental | Not described Receives: Drug: Artemisia Annua Leaf |
| Control arm | Placebo comparator | Not described Receives: Drug: Centaurii herba |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in whom the parasitaemia was cleared
No parasites detected in the thick blood smear (microscopic method)
Measured: On day 7 from the first day of treatment
Secondary outcomes (2)
Number of participants cured
Defined as the absence of Plasmodium infection (including reinfections) following treatment, as determined by microscopy and adjusted by PCR, in the per-protocol and intention-to-treat populations.
Measured: From the last day of treatment (day 7) to the end of the follow-up period on day 28
Number of adverse events
Types, proportions, severity, and causality of adverse events will be recorded as measures of tolerability and safety
Measured: From the first day of treatment (enrolment) to the end of the treatment period on day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic P.Falciparum MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, University of Tuebingen
- Responsible party
- Sponsor
- Investigators
- Steffen Borrmann, Prof., Study chair, Institut für Tropenmedizin, Universitätsklinikum Tübingen, Wilhelmstraße 27, 72074 Tübingen, GermanyAyôla Akim Adegnika, Prof., Study chair, Centre de Recherches Médicales de Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819825
- Sponsor's protocol ID
- SRC-2024-04
- Acronym
- ART-CT001
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided