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NCT Number: NCT07819825

Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection

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

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Key information

Conditions

Asymptomatic P.Falciparum Malaria Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre de Recherches Médicales de Lambaréné

Lambaréné, Gabon, BP: 242

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemisia Annua Leaf

Drug

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 herba

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre de Recherche Médicale de Lambaréné

Other

Collaborators

  • Institute of Tropical Medicine, University of Tuebingen

Registry information

Official study 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

Acronym: ART-CT001

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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