Emptying Malaria Reservoirs to Accelerate Malaria Elimination in High Transmission Settings

NCT ID: NCT05440773

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2024-02-29

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).

Conditions

Asymptomatic Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group 1 (TG 1)

Group of 8 persons receiving A. afra infusions of 5g/1liter of water, 3drinks a day, daily for 1week (7 days) (current recommendation)

Group Type: EXPERIMENTAL

Artemisia afra tea infusions

Intervention Type: OTHER

A. afra infusions of 5g/1litter of water, 3drinks a day, daily for 1week (7 days) (current recommendation).

Treatment group 2 (TG 2)

Group of 8 persons receiving A. afra infusions of 5g/500ml of water, 2drinks a day, daily for 1week (7 days) (increase concentration and decrease dose frequency).

Group Type: EXPERIMENTAL

Artemisia afra tea infusions

Intervention Type: OTHER

A. afra infusions of 5g/500ml of water, 2drinks a day, daily for 1week (7 days) (increase concentration and decrease dose frequency).

Treatment group 3 (TG 3)

Group of 8 persons receiving A. afra infusions,5g/1liter of water, 3drinkss a day, weekly for 4weeks (decrease dose frequency and increase length of treatment).

Group Type: EXPERIMENTAL

Artemisia afra tea infusions

Intervention Type: OTHER

A. afra infusions,5g/1liter of water, 3drinkss a day, weekly for 4weeks (decrease dose frequency and increase length of treatment).

Treatment group 4 (TG 4)

Group of 8 persons receiving flavored A. afra infusions, 5g/1liter of water, 3drinks a day, daily for1week (7 days) (current treatment with improved taste).

Group Type: EXPERIMENTAL

Artemisia afra tea infusions

Intervention Type: OTHER

A. afra infusions, 5g/1liter of water, 3drinks a day, daily for1week (7 days) (current treatment with improved taste).

Treatment group 5 (TG 5)

Group of 8 persons flavored A. afra infusions, 5g/500ml of water, 2drinks a day, daily for 1 week (7 days) (improved taste, increase concentration and decrease dose frequency).

Group Type: EXPERIMENTAL

Artemisia afra tea infusions

Intervention Type: OTHER

A. afra infusions, 5g/500ml of water, 2drinks a day, daily for 1 week (7 days) (improved taste, increase concentration and decrease dose frequency).

Treatment group 6 (TG 6)

Group of 8 persons receiving flavored A. afra infusions, 5g/1liter of water, 3drinks a day, weekly for 4weeks (improved taste, decrease dose frequency and increase length of treatment).

Group Type: EXPERIMENTAL

Artemisia afra tea infusions

Intervention Type: OTHER

Group of 8 persons receiving flavored A. afra infusions, 5g/1liter of water, 3drinks a day, weekly for 4weeks (improved taste, decrease dose frequency and increase length of treatment).

Treatment group 7

Group of 4 persons receiving flavored placebo infusions, 5g/liter of water, 3drinks a day, daily for 1week (7 days) (improved taste with no active molecule)

Group Type: PLACEBO_COMPARATOR

Flavored placebo infusions

Intervention Type: OTHER

Flavored placebo infusions, 5g/liter of water, 3drinks a day, daily for 1week (7 days) (improved taste with no active molecule)

Treatment group 8

Group of 4 participants receiving regular tea placebo taken as desired, daily for 1 week (7 days) (Regular tea with no active molecule).

Group Type: PLACEBO_COMPARATOR

Regular tea placebo

Intervention Type: OTHER

Regular tea placebo taken as desired, daily for 1 week (7 days) (Regular tea with no active molecule).

Interventions

Artemisia afra tea infusions

A. afra infusions of 5g/1litter of water, 3drinks a day, daily for 1week (7 days) (current recommendation).

Intervention Type: OTHER

Artemisia afra tea infusions

A. afra infusions of 5g/500ml of water, 2drinks a day, daily for 1week (7 days) (increase concentration and decrease dose frequency).

Intervention Type: OTHER

Artemisia afra tea infusions

A. afra infusions,5g/1liter of water, 3drinkss a day, weekly for 4weeks (decrease dose frequency and increase length of treatment).

Intervention Type: OTHER

Artemisia afra tea infusions

A. afra infusions, 5g/1liter of water, 3drinks a day, daily for1week (7 days) (current treatment with improved taste).

Intervention Type: OTHER

Artemisia afra tea infusions

A. afra infusions, 5g/500ml of water, 2drinks a day, daily for 1 week (7 days) (improved taste, increase concentration and decrease dose frequency).

Intervention Type: OTHER

Artemisia afra tea infusions

Group of 8 persons receiving flavored A. afra infusions, 5g/1liter of water, 3drinks a day, weekly for 4weeks (improved taste, decrease dose frequency and increase length of treatment).

Intervention Type: OTHER

Flavored placebo infusions

Flavored placebo infusions, 5g/liter of water, 3drinks a day, daily for 1week (7 days) (improved taste with no active molecule)

Intervention Type: OTHER

Regular tea placebo

Regular tea placebo taken as desired, daily for 1 week (7 days) (Regular tea with no active molecule).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suh Nchang Abenwie, MSc. MPH

Role: PRINCIPAL_INVESTIGATOR

UCLouvain, Bruxells -Belgium

Robert Annie, Professor

Role: STUDY_DIRECTOR

Université Catholique de Louvain

Souopgui Jacob, Professor

Role: STUDY_CHAIR

Université Libre de Bruxelles

Ghogomu Stephen, Professor

Role: STUDY_CHAIR

University of Buea, Cameroon

Frederick Michel, Professor

Role: STUDY_CHAIR

Université de Liège

Central Contacts

Suh Nchang Abenwie, MSc. MPH.

Role: CONTACT

abenwie.suhnchang@uclouvain.be

+237 676786985

Robert Annie, Professor

Role: CONTACT

annie.robert@uclouvain.be

+32.493.248.83

Other Identifiers

xxxxx

Identifier Type: -

Identifier Source: org_study_id