Asymptomatic MalariaNCT05440773
Emptying Malaria Reservoirs to Accelerate Malaria Elimination in High Transmission Settings
A study testing Artemisia afra tea infusions in people with Asymptomatic Malaria, run by Université Catholique de Louvain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Malaria
- What is being tested?
- Artemisia afra tea infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Artemisia afra tea infusions, Flavored placebo infusions, Regular tea placebo
- Keywords
- Artemisia infusions, Plasmodium reservoirs, malaria endemic areas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemisia afra tea infusionsOther
- afra infusions of 5g/1litter of water, 3drinks a day, daily for 1week (7 days) (current recommendation).
Artemisia afra tea infusionsOther
- afra infusions of 5g/500ml of water, 2drinks a day, daily for 1week (7 days) (increase concentration and decrease dose frequency).
Artemisia afra tea infusionsOther
- afra infusions,5g/1liter of water, 3drinkss a day, weekly for 4weeks (decrease dose frequency and increase length of treatment).
Artemisia afra tea infusionsOther
- afra infusions, 5g/1liter of water, 3drinks a day, daily for1week (7 days) (current treatment with improved taste).
Artemisia afra tea infusionsOther
- afra infusions, 5g/500ml of water, 2drinks a day, daily for 1 week (7 days) (improved taste, increase concentration and decrease dose frequency).
Artemisia afra tea infusionsOther
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).
Flavored placebo infusionsOther
Flavored placebo infusions, 5g/liter of water, 3drinks a day, daily for 1week (7 days) (improved taste with no active molecule)
Regular tea placeboOther
Regular tea placebo taken as desired, daily for 1 week (7 days) (Regular tea with no active molecule).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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) Receives: 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). Receives: Other: Regular tea placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in parasite load over time
Measured: 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.
Measured: 4weeks
Acceptability (adherence and completion) of Artemisia afra treatment by dose concentration, dose frequency, length of treatment, and formulation (flavor).
Measured: 4weeks
Safety (ASEs) of Artemisia afra treatment in participants by dose concentration, dose frequency length of treatment, and treatment formulation.
Measured: 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.
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study startApr 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic MalariaStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suh Nchang Abenwie, MSc. MPH, Principal investigator, UCLouvain, Bruxells -BelgiumRobert Annie, Professor, Study director, Université Catholique de LouvainSouopgui Jacob, Professor, Study chair, Université Libre de BruxellesGhogomu Stephen, Professor, Study chair, University of Buea, CameroonFrederick Michel, Professor, Study chair, Université de Liège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440773
- Sponsor's protocol ID
- xxxxx
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05440773
- Acronym / sponsor ID
- xxxxx
- Conditions
- Asymptomatic Malaria
- Keywords
- Artemisia infusions, Plasmodium reservoirs, malaria endemic areas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 (TG 1) | Experimental | Other: Artemisia afra tea infusionsGroup of 8 persons receiving A. afra infusions of 5g/1liter of water, 3drinks a day, daily for 1week (7 days) (current recommendation) |
| Treatment group 2 (TG 2) | Experimental | Other: Artemisia afra tea infusionsGroup 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). |
| Treatment group 3 (TG 3) | Experimental | Other: Artemisia afra tea infusionsGroup 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). |
| Treatment group 4 (TG 4) | Experimental | Other: Artemisia afra tea infusionsGroup of 8 persons receiving flavored A. afra infusions, 5g/1liter of water, 3drinks a day, daily for1week (7 days) (current treatment with improved taste). |
| Treatment group 5 (TG 5) | Experimental | Other: Artemisia afra tea infusionsGroup 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). |
| Treatment group 6 (TG 6) | Experimental | Other: Artemisia afra tea infusionsGroup 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 | Placebo comparator | Other: Flavored placebo infusionsGroup 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) |
| Treatment group 8 | Placebo comparator | Other: Regular tea placeboGroup of 4 participants receiving regular tea placebo taken as desired, daily for 1 week (7 days) (Regular tea with no active molecule). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemisia afra tea infusionsA. afra infusions of 5g/1litter of water, 3drinks a day, daily for 1week (7 days) (current recommendation). | Other | Treatment group 1 (TG 1) |
| Artemisia afra tea infusionsA. afra infusions of 5g/500ml of water, 2drinks a day, daily for 1week (7 days) (increase concentration and decrease dose frequency). | Other | Treatment group 2 (TG 2) |
| Artemisia afra tea infusionsA. afra infusions,5g/1liter of water, 3drinkss a day, weekly for 4weeks (decrease dose frequency and increase length of treatment). | Other | Treatment group 3 (TG 3) |
| Artemisia afra tea infusionsA. afra infusions, 5g/1liter of water, 3drinks a day, daily for1week (7 days) (current treatment with improved taste). | Other | Treatment group 4 (TG 4) |
| Artemisia afra tea infusionsA. afra infusions, 5g/500ml of water, 2drinks a day, daily for 1 week (7 days) (improved taste, increase concentration and decrease dose frequency). | Other | Treatment group 5 (TG 5) |
| Artemisia afra tea infusionsGroup 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 | Treatment group 6 (TG 6) |
| Flavored placebo infusionsFlavored placebo infusions, 5g/liter of water, 3drinks a day, daily for 1week (7 days) (improved taste with no active molecule) | Other | Treatment group 7 |
| Regular tea placeboRegular tea placebo taken as desired, daily for 1 week (7 days) (Regular tea with no active molecule). | Other | Treatment group 8 |
Primary outcome
Decrease in parasite load over time
Time frame: 4 weeks
4 secondary outcomes
Decrease in gametocyte load in carriers with Artemisia afra tea by dose concentration, dose frequency, length of treatment, and formulation.
Time frame: 4weeks
Acceptability (adherence and completion) of Artemisia afra treatment by dose concentration, dose frequency, length of treatment, and formulation (flavor).
Time frame: 4weeks
Safety (ASEs) of Artemisia afra treatment in participants by dose concentration, dose frequency length of treatment, and treatment formulation.
Time frame: 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.
Time frame: 4weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: No. No plan available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suh Nchang Abenwie, MSc. MPH principal investigator
UCLouvain, Bruxells -Belgium
Robert Annie, Professor study director
Université Catholique de Louvain
Souopgui Jacob, Professor study chair
Université Libre de Bruxelles
Questions about this trial
What is this clinical trial studying?
A study testing Artemisia afra tea infusions in people with Asymptomatic Malaria, run by Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suh Nchang Abenwie, MSc. MPH. (+237 676786985, abenwie.suhnchang@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in parasite load over time (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.