Emptying Malaria Reservoirs to Accelerate Malaria Elimination in High Transmission Settings

NCT05440773 | Unknown DMC

• 1 other identifier: xxxxx
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asymptomatic Malaria

Keywords

Artemisia infusions, Plasmodium reservoirs, malaria endemic areas

Outcome Measures

Primary Outcomes (1)

• Decrease in parasite load over time

  4 weeks

Secondary Outcomes (4)

• Decrease in gametocyte load in carriers with Artemisia afra tea by dose concentration, dose frequency, length of treatment, and formulation.

  4weeks

• Acceptability (adherence and completion) of Artemisia afra treatment by dose concentration, dose frequency, length of treatment, and formulation (flavor).

  4weeks

• Safety (ASEs) of Artemisia afra treatment in participants by dose concentration, dose frequency length of treatment, and treatment formulation.

  4weeks

• Likelihood and variability in the rate of reservoir elimination with treatment, compliance/ acceptability, and occurrence of side effects /adverse events in different treatment arms.

  4weeks

Study Arms (8)

Treatment group 1 (TG 1)

EXPERIMENTAL

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

Other: Artemisia afra tea infusions

Treatment group 2 (TG 2)

EXPERIMENTAL

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).

Other: Artemisia afra tea infusions

Treatment group 3 (TG 3)

EXPERIMENTAL

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).

Other: Artemisia afra tea infusions

Treatment group 4 (TG 4)

EXPERIMENTAL

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).

Other: Artemisia afra tea infusions

Treatment group 5 (TG 5)

EXPERIMENTAL

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).

Other: Artemisia afra tea infusions

Treatment group 6 (TG 6)

EXPERIMENTAL

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).

Other: Artemisia afra tea infusions

Treatment group 7

PLACEBO COMPARATOR

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)

Other: Flavored placebo infusions

Treatment group 8

PLACEBO COMPARATOR

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

Other: Regular tea placebo

Interventions

Artemisia afra tea infusions OTHER

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

Treatment group 1 (TG 1)

Flavored placebo infusions OTHER

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

Treatment group 7

Regular tea placebo OTHER

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

Treatment group 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Officials

• Suh Nchang Abenwie, MSc. MPH

  UCLouvain, Bruxells -Belgium

  PRINCIPAL INVESTIGATOR

• Robert Annie, Professor

  Université Catholique de Louvain

  STUDY DIRECTOR

• Souopgui Jacob, Professor

  Université Libre de Bruxelles

  STUDY CHAIR

• Ghogomu Stephen, Professor

  University of Buea, Cameroon

  STUDY CHAIR

• Frederick Michel, Professor

  Université de Liège

  STUDY CHAIR

Central Study Contacts

Suh Nchang Abenwie, MSc. MPH.

CONTACT

+237 676786985; abenwie.suhnchang@uclouvain.be

Robert Annie, Professor

CONTACT

+32.493.248.83; annie.robert@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 1, 2022
• Study Start: April 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: February 1, 2024
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share