Clinical trial NCT05440773: Emptying Malaria Reservoirs to Accelerate Malaria Elimination in High Transmission Settings
Official title: A Phase 2 Randomized, Controlled Study to Evaluate the Activity Level, Optimal Dosage, Safety, and Accepted Formulation of Artemisia Afra Tea Infusions in Eliminating Plasmodium Reservoirs in Malaria Endemic Areas of Cameroon and Rwanda
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asymptomatic Malaria
Keywords: Artemisia infusions, Plasmodium reservoirs, malaria endemic areas
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a Phase 2 randomized controlled, partial-blind, parallel group study in plasmodium infected asymptomatic adults 18 years and older, with 8 study arms. It will use the adapted Zelen design, which has two steps in the consent process. In the first step, there is an informed consent from all participants for a cohort lifestyle study. According to this consent, participants are randomized without knowledge about the detailed protocol.

In the second step, only participants from the intervention group will receive the information about the intervention and the second consent will be obtained from them. The participants who will decline to participate to an intervention will continue in the cohort study, as the control group.

Detailed description: This study will use the adapted Zelen design which has two steps in the consent process. At step one, informed individuals (students and workers) will be invited to participate in a screening and cohort survey on asymptomatic malaria, aimed at understanding the comportment of plasmodium parasite in asymptomatic plasmodium carriers over time. After informed consent is obtained during the first encounter (day 0), baseline assessments will be done and sociodemographic variables, clinical/medical history, physical assessment, prior medications information and participants' contact details will be recorded. Blood samples will be collected from each participant and examined for the presence of parasites (Gametocytes) using malaria rapid diagnostic test kit (mRDT). RDT positive samples will be re-examined with qPCR (quantitative polymerase chain reaction) and direct microscopy for confirmation. The qCPR will be repeated for negative samples and participants excluded if still negative. All qPCR positive samples will be further analyzed with rt PCR (real time polymerase chain reaction), for parasite quantification and specific stage identification, targeting specific parts of the gametocyte genes. Participants who fulfil the inclusion criteria will be randomly allocated in the 8 study arms in a 2:2:2: 2:2:2:1:1 ratio for the 6 treatment and 2 control arms, respectively. In the second step, only participants from the intervention groups will receive the information about the intervention and a second consent will be obtained from them (TG1-TG7). Treatment administration will be based on the allocation arm. The treatments will consist of Artemisia afra tea infusions for the 6 trial arms versus flavored placebo infusions and desired regular tea for the 2 control arms. The participants who will decline to participate to an intervention will continue in the cohort study, as a control group on regular tea (TG 8).

During 4 consecutive weeks, all participants will be tested using rtPCR once a week on Day 7, 14, 28 and 35, in order to assess gametocyte elimination rate with teas. During the 4 weeks, participants will be monitored and encouraged to comply to the prescribed treatment, and also monitored/assessed for any clinical symptoms and treatment reactions (ASEs and AE).

Eligibility criteria: Inclusion Criteria:

* Be student or worker of a participating University.
* Be 18 years and above, and in good general health condition.
* Have a device (phone, tablet, etc) that will support remote visits.
* Sign written informed consent form.
* Screened positive for malaria (RDT + and qPCR +) but asymptomatic.

Exclusion Criteria:

* To have a known hypersensitivity to any ingredients of the tea.
* Currently taking a malaria drug for prevention or treatment.
* To have participated in another malaria drug trial or device in the last 14days.
* To have a history or presence of clinically significant medical, psychiatric, or emotional condition.
* Reported diabetic

Primary outcomes:
measure: Decrease in parasite load over time
timeFrame: 4 weeks
Secondary outcomes:
measure: Decrease in gametocyte load in carriers with Artemisia afra tea by dose concentration, dose frequency, length of treatment, and formulation.
timeFrame: 4weeks
measure: Acceptability (adherence and completion) of Artemisia afra treatment by dose concentration, dose frequency, length of treatment, and formulation (flavor).
timeFrame: 4weeks
measure: Safety (ASEs) of Artemisia afra treatment in participants by dose concentration, dose frequency length of treatment, and treatment formulation.
timeFrame: 4weeks
measure: Likelihood and variability in the rate of reservoir elimination with treatment, compliance/ acceptability, and occurrence of side effects /adverse events in different treatment arms.
timeFrame: 4weeks
Other outcomes:
Locations:
Study officials:
affiliation: UCLouvain, Bruxells -Belgium
name: Suh Nchang Abenwie, MSc. MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Catholique de Louvain
name: Robert Annie, Professor
role: STUDY_DIRECTOR
affiliation: Université Libre de Bruxelles
name: Souopgui Jacob, Professor
role: STUDY_CHAIR
affiliation: University of Buea, Cameroon
name: Ghogomu Stephen, Professor
role: STUDY_CHAIR
affiliation: Université de Liège
name: Frederick Michel, Professor
role: STUDY_CHAIR
References: