Artemisia Annua Infusion for the Treatment of Asymptomatic Plasmodium Falciparum Infection

Phase 1Not Yet RecruitingNCT07819825

Centre de Recherche Médicale de Lambaréné20 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asymptomatic P.Falciparum Malaria

Interventions

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

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

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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