Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection (ART-CT001)

September 9, 2026 updated by: Centre de Recherche Médicale de Lambaréné

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?

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jean Claude Dejon Agobé, MD
  • Phone Number: 0024177989191
  • Email: jcagobe@cermel.org

Study Locations

  • Gabon
    • Gabon
      • Lambaréné, Gabon, Gabon, BP: 242
        • Centre de Recherches Médicales de Lambaréné
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean Claude Dejon Agobé, MD, PhD
        • Sub-Investigator:
          • Christian Chassem Lapue, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control arm
Drug: Centaurii herba
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.
Other Names:
  • Centaurium erythrea
Experimental: Artemisia arm
Drug: Artemisia Annua Leaf
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in whom the parasitaemia was cleared
Time Frame: On day 7 from the first day of treatment
No parasites detected in the thick blood smear (microscopic method)
On day 7 from the first day of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants cured
Time Frame: From the last day of treatment (day 7) to the end of the follow-up period on day 28
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.
From the last day of treatment (day 7) to the end of the follow-up period on day 28
Number of adverse events
Time Frame: From the first day of treatment (enrolment) to the end of the treatment period on day 7
Types, proportions, severity, and causality of adverse events will be recorded as measures of tolerability and safety
From the first day of treatment (enrolment) to the end of the treatment period on day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche Médicale de Lambaréné

Collaborators

Institute of Tropical Medicine, University of Tuebingen

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRC-2024-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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