Malaria,FalciparumPhase 3MATAMALNCT04844905
Adjunctive Ivermectin Mass Drug Administration for Malaria Control
A Phase 3 study testing Ivermectin and Dihydroartemisinin-piperaquine in people with Malaria,Falciparum and Neglected Tropical Diseases, run by London School of Hygiene and Tropical Medicine at 1 site in Guinea-Bissau.
Trial summary
This is a cluster-randomized placebo-controlled clinical trial to evaluate the additive benefit of Ivermectin (IVM) (or Placebo) mass drug administration (MDA) to dihydroartemisinin-piperaquine (DP) MDA for malaria control in a moderate to low malaria-endemic setting as an adjunctive strategy to existing programmatic… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum, Neglected Tropical Diseases, Strongyloidiasis
- What is being tested?
- Ivermectin and Dihydroartemisinin-piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24,000 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 3 May 2021to Aug 2023
- Phase
- Phase 3
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age over six months to receive dihydroartemisinin-piperaquine
- Height over 90cm or weight over 15kg to receive ivermectin or placebo
- Willingness to adhere to trial procedures
- Individual written, informed consent from the participant or parent/guardian in the case of participants below the age of 18 years (and assent in young people between the ages of 12 and 17 years of age)
Who cannot join
- Known severe chronic illness (AIDS, Tuberculosis, chronic malnutrition)
- Known hypersensitivity to either dihydroartemisinin-piperaquine or ivermectin
- Pregnancy (any trimester) and breastfeeding (for ivermectin (or placebo)) and pregnancy (first trimester only) (for dihydroartemisinin-piperaquine)
- Travel to a Loa loa endemic country (eg Central African Republic) (for ivermectin (or placebo))
- Concomitant drugs that influence cardiac function or affect the corrected QT interval (for dihydroartemisinin-piperaquine)
Trial locations and contacts
1 site in 1 country.
David CW Mabey contact
Guinea-Bissau1 site, 1 recruiting
- Recruiting
Bijagos Archipelago (islands)
Bissau
Amabelia Rodrigues, PhD, a.rodrigues@bandim.org
Harry Hutchins, MBChB, harry.hutchins@lshtm.ac.uk
About this study
Official title: Adjunctive Ivermectin Mass Drug Administration for Malaria Control on the Bijagos Archipelago of Guinea Bissau: A Cluster-randomized Placebo-controlled Trial
This is a cluster-randomized placebo-controlled clinical trial to evaluate the additive benefit of Ivermectin (IVM) (or Placebo) mass drug administration (MDA) to dihydroartemisinin-piperaquine (DP) MDA for malaria control in a moderate to low malaria-endemic setting as an adjunctive strategy to existing programmatic malaria control measures. The regime of DP and IVM will target both human reservoirs of Plasmodium falciparum and the Anopheles gambiae vector respectively, with the aim of interrupting transmission. The trial will be conducted on the Bijagos Archipelago, where islands (clusters) will be randomised to receive seasonal DP and IVM or DP and Placebo MDA. The primary outcome will be the prevalence of infection with Plasmodium falciparum in all age groups detected by nucleic acid amplification testing during the peak malaria transmission season after two years of intervention.
Read the detailed description
The objectives of this trial are
- To evaluate the impact of adjunctive IVM to DP MDA on malaria transmission in communities with high ITN coverage.
- To evaluate the impact of IVM MDA on An. gambiae population density and age-structure.
- To evaluate the impact of IVM MDA on the prevalence of co-endemic IVM-susceptible Neglected Tropical Diseases (lymphatic filariasis, soil transmitted helminths and scabies)
- To evaluate acceptability, feasibility and access to MDA as a strategy for malaria control and to identify the most acceptable way of achieving and sustaining high coverage MDA with IVM and DP.
This cluster-randomized placebo-controlled trial has two arms. A total of 24 clusters will be randomly assigned to receive DP + IVM MDA or DP+ Placebo MDA using computer-generated random numbers. To mitigate against contamination effects, the majority of clusters will be separate islands and will be separated by distances greater than 2km. On the two islands that are divided (each into two clusters), a buffer zone of 2km between each cluster will be ensured. The total population of the archipelago is 24,000. The investigators will ensure balance between trial arms with respect to population size, baseline Plasmodium falciparum prevalence and access to health care. All clusters will receive the standard programmatic malaria control interventions implemented by the National Malaria Control Programme which includes insecticide-treated nets (ITN), intermittent preventative treatment in pregnancy (IPTp), seasonal malarial chemoprophylaxis (SMC) for children aged 3-59 months and case diagnosis and treatment (CDT) with Artemether-lumefantrine.
- Conditions
- Malaria,Falciparum, Neglected Tropical Diseases, Strongyloidiasis, Lymphatic Filariasis, Scabies, Hook Worm
- Being tested
- Ivermectin, Placebo, Dihydroartemisinin-piperaquine
- Keywords
- Vector Control, Mass Drug Administration, Integrated Disease Control, Malaria, Guinea Bissau, West Africa, Antimalarials, Ivermectin, Dihydroartemisinin, Piperaquine
- Medical subject headings
- Malaria, Falciparum, Neglected Diseases, Strongyloidiasis, Elephantiasis, Filarial, Scabies, Ancylostomiasis, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Ivermectin will be given as tablets of 3 or 6mg. It will be given at 300-400μg/kg/day for 3 days (to the nearest whole tablet) each month for 3 months. It will be taken on an empty stomach with water.
PlaceboDrug
Placebo will be given as tablets of 3 or 6mg (identical to Ivermectin in colour, size, shape and packaging). It will be given at 300-400μg/kg/day for 3 days (to the nearest whole tablet) each month for 3 months. It will be taken by mouth with water and without food.
Dihydroartemisinin-piperaquineDrug
Also called Eurartesim
Dihydroartemisinin-piperaquine will be given as tablets of 320/40mg (adult) and 160/20mg (child) piperaquine/dihydroartemisinin per tablet. Administration of a full course of dihydroartemisinin-piperaquine will be given in accordance with the manufacturer's guidelines once daily for 3 days each month for 3 months according to body weight. Dihydroartemisinin-piperaquine will be taken by mouth with water and without food.
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin Mass Drug Administration | Experimental | Ivermectin and Dihydroartemisinin-piperaquine MDA will be given to all eligible participants in each cluster (island) in addition to the standard national malaria control programme interventions. Receives: Drug: Ivermectin; Drug: Dihydroartemisinin-piperaquine |
| Placebo Mass Drug Administration | Placebo comparator | Placebo and Dihydroartemisinin-piperaquine MDA will be given to all eligible participants in each cluster (island) in addition to the standard national malaria control programme interventions. Receives: Drug: Placebo; Drug: Dihydroartemisinin-piperaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of infection with Plasmodium falciparum
Prevalence of infection with Plasmodium falciparum in all age groups estimated using a cross-sectional survey sample conducted during peak transmission season after 2 years of intervention
Measured: 2 years
Secondary outcomes (12)
Vector parous rate
Vector parous rate will be determined by assessment of mosquitoes trapped 7-14 days following MDA. Vector parity will be used to determine Anopheles gambiae age structure to estimate vector survival between arms.
Measured: 7-14 days post-MDA
Prevalence of infection with Plasmodium falciparum
Prevalence of infection with Plasmodium falciparum in all age groups estimated using a cross-sectional survey sample conducted after the first year of intervention
Measured: 1 year
Incidence of clinical malaria (Passive Case Detection)
Incidence of clinical malaria diagnosed at health facilities confirmed by malaria Rapid Diagnostic Test
Measured: For six months during the malaria transmission season
Incidence of clinical malaria (Active Case Detection)
Incidence of clinical malaria confirmed by malaria Rapid Diagnostic Test in a cohort of 50 children per cluster aged 5-14 years
Measured: For six months during the malaria transmission season
Age-adjusted prevalence of recent exposure to Plasmodium falciparum
Mean Median Fluorescence Intensity of serological markers associated with recent exposure to Plasmodium falciparum in all age groups estimated using a cross-sectional survey sample during peak transmission season after each year of intervention
Measured: Peak transmission season at 1 year and 2 years
Vector density
Total number of trapped mosquitoes per cluster
Measured: For six months during the malaria transmission season
Vector species composition
Species characterisation using nucleic acid amplification tests as a proportion of total mosquitoes caught in traps
Measured: For six months during the malaria transmission season
Prevalence of exposure to Anopheles exposure
Mean Median Fluorescence Intensity of serological markers associated with exposure to Anopheles salivary antigen in all age groups estimated using a cross-sectional survey sample
Measured: Peak transmission season at 1 year and 2 years
Vector sporozoite rates
Proportion of Plasmodium falciparum circumsporozoite antibody (CSP) positive mosquitoes caught in traps
Measured: For six months during the malaria transmission season
Prevalence of Ivermectin-susceptible Neglected Tropical Diseases (NTDs)
Prevalence of IVM-susceptible NTDs (scabies, strongyloides, other soil-transmitted helminths and lymphatic filariasis) and head lice using clinical and serological parameters estimated using a cross-sectional survey sample during the dry season after two years of intervention.
Measured: 2 years
MDA coverage estimates
Cluster level coverage estimates calculated from MDA distribution and denominator census
Measured: During MDA in year 1 and year 2
Prevalence of resistance to artemisinin and partner drugs in humans
Prevalence of resistance to artemisinin and partner drugs in humans using molecular markers of resistance in all age groups estimated using a cross-sectional survey sample
Measured: Peak transmission season at 1 year and at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start3 May 2021
- Primary completionMar 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms with clusters randomized to DP+IVM or DP+Placebo with a 1:1 ratio
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, Ministerio de Saude Publica, Guinee-Bissau, Bandim Health Project, Instituto Nacional de Estudos e Pesquisas, Guinee-Bissau
- Responsible party
- Sponsor
- Investigators
- Anna R Last, MBChB PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844905
- Sponsor's protocol ID
- 19156
- Acronym
- MATAMAL
- Status last verified
- Feb 2022
- First submitted
- 17 Mar 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a manuscript in preparation detailing the study protocol and statistical analysis plan. The participant information and and informed consent form may be requested from the trial research team. Results and a clinical study report will be made available within six months of completion of the trial. Analytic code will be made available under a Creative Commons license. Publication of results will be open-access and available in pre-print on MedRxiv (The Preprint Server for Health Sciences).
Publications
Hutchins H, Pretorius E, Bradley J, Teixeira da Silva E, Vasileva H, Ndiath MO, Jones RT, Soumare HDM, Nyang H, Prom A, Sambou S, Ceesay F, Ceesay S, Moss S, Mabey D, Djata P, Nante JE, Martins C, Logan JG, Slater H, Tetteh K, Drakeley C, D'Alessandro U, Rodrigues A, Last A. Adjunctive ivermectin mass drug administration for malaria control on the Bijagos Archipelago of Guinea-Bissau (MATAMAL): a quadruple-blinded, cluster-randomised, placebo-controlled trial. Lancet Infect Dis. 2025 Apr;25(4):424-434. doi: 10.1016/S1473-3099(24)00580-2. Epub 2024 Nov 14.
PubMed 39551062Hutchins H, Bradley J, Pretorius E, Teixeira da Silva E, Vasileva H, Jones RT, Ndiath MO, Dit Massire Soumare H, Mabey D, Nante EJ, Martins C, Logan JG, Slater H, Drakeley C, D'Alessandro U, Rodrigues A, Last AR. Protocol for a cluster randomised placebo-controlled trial of adjunctive ivermectin mass drug administration for malaria control on the Bijagos Archipelago of Guinea-Bissau: the MATAMAL trial. BMJ Open. 2023 Jul 7;13(7):e072347. doi: 10.1136/bmjopen-2023-072347.
PubMed 37419638
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Ivermectin Mass Drug Administration for Malaria Control on the Bijagos Archipelago of Guinea Bissau: A Cluster-randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04844905
- Acronym / sponsor ID
- MATAMAL / 19156
- Conditions
- Malaria,Falciparum, Neglected Tropical Diseases, Strongyloidiasis, Lymphatic Filariasis, Scabies, Hook Worm
- Keywords
- Vector Control, Mass Drug Administration, Integrated Disease Control, Malaria, Guinea Bissau, West Africa, Antimalarials, Ivermectin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, Ministerio de Saude Publica, Guinee-Bissau, Bandim Health Project, Instituto Nacional de Estudos e Pesquisas, Guinee-Bissau
- Study start
- 3 May 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 14 Apr 2021 (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.
This is a cluster-randomized placebo-controlled clinical trial to evaluate the additive benefit of Ivermectin (IVM) (or Placebo) mass drug administration (MDA) to dihydroartemisinin-piperaquine (DP) MDA for malaria control in a moderate to low malaria-endemic setting as an adjunctive strategy to existing programmatic malaria control measures. The regime of DP and IVM will target both human reservoirs of Plasmodium falciparum and the Anopheles gambiae vector respectively, with the aim of interrupting transmission. The trial will be conducted on the Bijagos Archipelago, where islands (clusters) will be randomised to receive seasonal DP and IVM or DP and Placebo MDA. The primary outcome will be the prevalence of infection with Plasmodium falciparum in all age groups detected by nucleic acid amplification testing during the peak malaria transmission season after two years of intervention.
Detailed description
The objectives of this trial are
- To evaluate the impact of adjunctive IVM to DP MDA on malaria transmission in communities with high ITN coverage.
- To evaluate the impact of IVM MDA on An. gambiae population density and age-structure.
- To evaluate the impact of IVM MDA on the prevalence of co-endemic IVM-susceptible Neglected Tropical Diseases (lymphatic filariasis, soil transmitted helminths and scabies)
- To evaluate acceptability, feasibility and access to MDA as a strategy for malaria control and to identify the most acceptable way of achieving and sustaining high coverage MDA with IVM and DP.
This cluster-randomized placebo-controlled trial has two arms. A total of 24 clusters will be randomly assigned to receive DP + IVM MDA or DP+ Placebo MDA using computer-generated random numbers. To mitigate against contamination effects, the majority of clusters will be separate islands and will be separated by distances greater than 2km. On the two islands that are divided (each into two clusters), a buffer zone of 2km between each cluster will be ensured. The total population of the archipelago is 24,000. The investigators will ensure balance between trial arms with respect to population size, baseline Plasmodium falciparum prevalence and access to health care. All clusters will receive the standard programmatic malaria control interventions implemented by the National Malaria Control Programme which includes insecticide-treated nets (ITN), intermittent preventative treatment in pregnancy (IPTp), seasonal malarial chemoprophylaxis (SMC) for children aged 3-59 months and case diagnosis and treatment (CDT) with Artemether-lumefantrine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms with clusters randomized to DP+IVM or DP+Placebo with a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Ivermectin Mass Drug Administration | Experimental | Drug: Ivermectin, Drug: Dihydroartemisinin-piperaquineIvermectin and Dihydroartemisinin-piperaquine MDA will be given to all eligible participants in each cluster (island) in addition to the standard national malaria control programme interventions. |
| Placebo Mass Drug Administration | Placebo comparator | Drug: Placebo, Drug: Dihydroartemisinin-piperaquinePlacebo and Dihydroartemisinin-piperaquine MDA will be given to all eligible participants in each cluster (island) in addition to the standard national malaria control programme interventions. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age over six months to receive dihydroartemisinin-piperaquine
- Height over 90cm or weight over 15kg to receive ivermectin or placebo
- Willingness to adhere to trial procedures
- Individual written, informed consent from the participant or parent/guardian in the case of participants below the age of 18 years (and assent in young people between the ages of 12 and 17 years of age)
Key exclusion criteria (5 listed)
- Known severe chronic illness (AIDS, Tuberculosis, chronic malnutrition)
- Known hypersensitivity to either dihydroartemisinin-piperaquine or ivermectin
- Pregnancy (any trimester) and breastfeeding (for ivermectin (or placebo)) and pregnancy (first trimester only) (for dihydroartemisinin-piperaquine)
- Travel to a Loa loa endemic country (eg Central African Republic) (for ivermectin (or placebo))
- Concomitant drugs that influence cardiac function or affect the corrected QT interval (for dihydroartemisinin-piperaquine)
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 |
|---|---|---|
| IvermectinIvermectin will be given as tablets of 3 or 6mg. It will be given at 300-400μg/kg/day for 3 days (to the nearest whole tablet) each month for 3 months. It will be taken on an empty stomach with water. | Drug | Ivermectin Mass Drug Administration |
| PlaceboPlacebo will be given as tablets of 3 or 6mg (identical to Ivermectin in colour, size, shape and packaging). It will be given at 300-400μg/kg/day for 3 days (to the nearest whole tablet) each month for 3 months. It will be taken by mouth with water and without food. | Drug | Placebo Mass Drug Administration |
| Dihydroartemisinin-piperaquineAlso: EurartesimDihydroartemisinin-piperaquine will be given as tablets of 320/40mg (adult) and 160/20mg (child) piperaquine/dihydroartemisinin per tablet. Administration of a full course of dihydroartemisinin-piperaquine will be given in accordance with the manufacturer's guidelines once daily for 3 days each month for 3 months according to body weight. Dihydroartemisinin-piperaquine will be taken by mouth with water and without food. | Drug | Ivermectin Mass Drug Administration, Placebo Mass Drug Administration |
Primary outcome
Prevalence of infection with Plasmodium falciparum
Time frame: 2 years
Prevalence of infection with Plasmodium falciparum in all age groups estimated using a cross-sectional survey sample conducted during peak transmission season after 2 years of intervention
12 secondary outcomes
Vector parous rate
Time frame: 7-14 days post-MDA
Prevalence of infection with Plasmodium falciparum
Time frame: 1 year
Incidence of clinical malaria (Passive Case Detection)
Time frame: For six months during the malaria transmission season
Incidence of clinical malaria (Active Case Detection)
Time frame: For six months during the malaria transmission season
Age-adjusted prevalence of recent exposure to Plasmodium falciparum
Time frame: Peak transmission season at 1 year and 2 years
Vector density
Time frame: For six months during the malaria transmission season
Vector species composition
Time frame: For six months during the malaria transmission season
Prevalence of exposure to Anopheles exposure
Time frame: Peak transmission season at 1 year and 2 years
Vector sporozoite rates
Time frame: For six months during the malaria transmission season
Prevalence of Ivermectin-susceptible Neglected Tropical Diseases (NTDs)
Time frame: 2 years
MDA coverage estimates
Time frame: During MDA in year 1 and year 2
Prevalence of resistance to artemisinin and partner drugs in humans
Time frame: Peak transmission season at 1 year and at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 39551062Hutchins H, Pretorius E, Bradley J, Teixeira da Silva E, Vasileva H, Ndiath MO, Jones RT, Soumare HDM, Nyang H, Prom A, Sambou S, Ceesay F, Ceesay S, Moss S, Mabey D, Djata P, Nante JE, Martins C, Logan JG, Slater H, Tetteh K, Drakeley C, D'Alessandro U, Rodrigues A, Last A. Adjunctive ivermectin mass drug administration for malaria control on the Bijagos Archipelago of Guinea-Bissau (MATAMAL): a quadruple-blinded, cluster-randomised, placebo-controlled trial. Lancet Infect Dis. 2025 Apr;25(4):424-434. doi: 10.1016/S1473-3099(24)00580-2. Epub 2024 Nov 14.
- Derived from this study: PubMed 37419638Hutchins H, Bradley J, Pretorius E, Teixeira da Silva E, Vasileva H, Jones RT, Ndiath MO, Dit Massire Soumare H, Mabey D, Nante EJ, Martins C, Logan JG, Slater H, Drakeley C, D'Alessandro U, Rodrigues A, Last AR. Protocol for a cluster randomised placebo-controlled trial of adjunctive ivermectin mass drug administration for malaria control on the Bijagos Archipelago of Guinea-Bissau: the MATAMAL trial. BMJ Open. 2023 Jul 7;13(7):e072347. doi: 10.1136/bmjopen-2023-072347.
- Individual participant dataSharing planned: Yes. There is a manuscript in preparation detailing the study protocol and statistical analysis plan. The participant information and and informed consent form may be requested from the trial research team. Results and a clinical study report will be made available within six months of completion of the trial. Analytic code will be made available under a Creative Commons license. Publication of results will be open-access and available in pre-print on MedRxiv (The Preprint Server for Health Sciences).
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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.
David CW Mabey contact
Anna R Last, MBChB PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin and Dihydroartemisinin-piperaquine in people with Malaria,Falciparum and Neglected Tropical Diseases, run by London School of Hygiene and Tropical Medicine at 1 site in Guinea-Bissau.
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 4 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 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anna R Last, MBChB PhD (0044(0)2072770 ext. 2770, anna.last@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of infection with Plasmodium falciparum (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04844905, which also lists 2 linked publications.
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 24 Feb 2022.