Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorCentre de Recherche Médicale de Lambaréné

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Artemisia armExperimental treatment 1 intervention
Group B: Control armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants in whom the parasitaemia was cleared

No parasites detected in the thick blood smear (microscopic method)

Time frame
On day 7 from the first day of treatment

Secondary outcomes

1

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.

Time frame
From the last day of treatment (day 7) to the end of the follow-up period on day 28
2

Number of adverse events

Types, proportions, severity, and causality of adverse events will be recorded as measures of tolerability and safety

Time frame
From the first day of treatment (enrolment) to the end of the treatment period on day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre de Recherche Médicale de Lambaréné

Lead sponsor

Institute of Tropical Medicine, University of Tuebingen

Collaborator

This trial is not recruiting at the moment. You can still explore other options: