MalariaAEGIS UgandaNCT06122142
Spatial Repellents for Malaria Control
A study testing Transfluthrin - delivery by paid study personnel, Transfluthrin - delivery by voucher system and Transfluthrin - delivery by village health teams in people with Malaria, run by University of Notre Dame at 2 sites in Uganda.
Trial summary
The primary objective of the study is to demonstrate and quantify the effectiveness of a spatial repellent (SR) product, in reducing malaria infection in humans under operational program conditions in a humanitarian assistance context. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Transfluthrin - delivery by paid study personnel, Transfluthrin - delivery by voucher system and Transfluthrin - delivery by village health teams
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUganda
- Study dates
- May 2024to May 2025
- 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 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ≥ 6 months to ≤ 59 months
- Children ≥ 6 months to ≤ 59 months with Hb > 7g/dL and no other serious illness
- Sleeps in cluster (i.e. study area) ≥ 90% of nights during any given month
- Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the Trial
- Provision of informed consent form (ICF) signed by the parent(s) or guardian
Who cannot join
- Children < 6 months and > 59 months
- Children ≥ 6 months to ≤ 59 months with Hb ≤ 7g/dL with signs of other serious illness or Hb ≤ 7 g/dL with signs of clinical decompensation
- Sleeps in cluster (i.e. study area) < 90% of nights during any given month
- Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- No provision of ICF signed by the parent(s) or guardian
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Catholic Relief Services
Kampala
Infectious Disease Research Collaboration
Kampala
About this study
Official title: Advancing Spatial Repellents for Malaria Control: Effectiveness and Cost-Effectiveness of a Spatial Repellent Under Operational Use in Northern Uganda
The primary objective of the study is to demonstrate and quantify the effectiveness of a spatial repellent (SR) product, in reducing malaria infection in humans under operational program conditions in a humanitarian assistance context. The design will be a cluster Randomized Control Trial (cRCT) representing an operational research study.
Read the detailed description
Spatial repellents (SRs) have been widely used for the prevention of mosquito bites, and preliminary findings suggest efficacy against both malaria and Aedes-borne viruses but their effectiveness in reducing mosquito borne diseases under operational use has never been evaluated. SRs have the potential of being critical tools in the prevention of mosquito borne diseases in contexts where typical vectors control strategies, such as Insecticide-Treated Nets (ITNs) and indoor residual spray (IRS), are inaccessible or underutilized such as among displaced peoples or in emergency relief settings. To address this knowledge gap, the Bidibidi refugee settlement in the Yumbe District of North West Uganda was selected as the study site to estimate the impact of the SR on malaria related outcomes under operational use conditions given ongoing humanitarian relief efforts. Children will be enrolled in 3 separate cohorts to establish effectiveness of SRs in reducing malaria infection in distribution channels. One cohort will estimate the direct effect of the SR distributed through a reference channel (study personnel distribution). The two remaining cohorts will estimate the protection of the SR distributed through a voucher channel and village health team (VHT) channel. Cohorts will be followed twice a month (approximately every 15 days) during the first scheduled household visit in the month, a blood sample will be taken for malaria rapid diagnostic test (RDT) (Monthly Visit #1); and, during the second scheduled household visit, a blood sample will only be taken if the participant has a recent history of fever (Monthly Visit #2). The incidence of malaria in each cohort will be estimated and compared to the reference cohort to determine the benefit of using an SR in an area with high, year-round transmission of malaria.
- Conditions
- Malaria
- Being tested
- Transfluthrin - delivery by paid study personnel, Transfluthrin - delivery by voucher system, Transfluthrin - delivery by village health teams
- Keywords
- Malaria, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence
- Medical subject headings
- Malaria, Vector Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfluthrin - delivery by paid study personnelDevice
Passive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel
Transfluthrin - delivery by voucher systemDevice
Passive emanator with formulated transfluthrin, voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.
Transfluthrin - delivery by village health teamsDevice
Passive emanator with formulated transfluthrin, village health teams will distribute SR products.
| Study group | Role | What they receive |
|---|---|---|
| Study personnel distribution channel | Active comparator | SR product will be delivered by paid study personnel. Receives: Device: Transfluthrin - delivery by paid study personnel |
| Voucher distribution channel | Experimental | Voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household. Receives: Device: Transfluthrin - delivery by voucher system |
| Village health team distribution channel | Experimental | Village health teams will distribute SR products. Receives: Device: Transfluthrin - delivery by village health teams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of SR against malaria infection (both first-time and recurrent).
Measured by rapid diagnostic tests in children aged between 6 months to 59 months.
Measured: 12 months
Secondary outcomes (2)
Cost-effectiveness of SR distribution.
Measure cost of SR implementation in relation to manufacturing, efficacy, and coverage to model projections of cost-effectiveness.
Measured: 12 months
Adverse Events and Serious Adverse Events.
Measured by solicited and unsolicited reports during the intervention period. Mean, minimum and maximum frequency and percentage of Adverse Events and Serious Adverse Eventss across clusters among enrolled subjects will be summarized by distribution channel arm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Why it stopped: Funder stop request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design will be a prospective cluster Randomized Control Trial (cRCT)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- S.C. Johnson & Son, Inc., Catholic Relief Services, Infectious Diseases Research Collaboration, Uganda
- Responsible party
- Sponsor
- Investigators
- John P Grieco, Ph.D., Study director, University of Notre DameSuzanne Van Hulle, M.H.S., Principal investigator, Catholic Relief Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122142
- Sponsor's protocol ID
- 23-05-7909
- Acronym
- AEGIS Uganda
- Status last verified
- Mar 2025
- First submitted
- 27 Oct 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytical data will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.
Publications
Achee NL, Bangs MJ, Farlow R, Killeen GF, Lindsay S, Logan JG, Moore SJ, Rowland M, Sweeney K, Torr SJ, Zwiebel LJ, Grieco JP. Spatial repellents: from discovery and development to evidence-based validation. Malar J. 2012 May 14;11:164. doi: 10.1186/1475-2875-11-164.
PubMed 22583679The Republic of Uganda Ministry of Health. Annual Health Sector Performance Report Financial Year 2021/22. Ministry of Health, Uganda.
Uganda National Malaria Control Division (NMCD), Uganda Bureau of Statistics (UBOS), and ICF. 2019. 2018-19 Uganda Malaria Indicator Survey Atlas of Key Indicators. Kampala, Uganda, and Rockville, Maryland, USA: NMCD, UBOS, and ICF.
World Health Organization. Twelfth meeting of the WHO Vector Control Advisory Group. Geneva: World Health Organization; 2020.
Hamel MJ, Otieno P, Bayoh N, Kariuki S, Were V, Marwanga D, Laserson KF, Williamson J, Slutsker L, Gimnig J. The combination of indoor residual spraying and insecticide-treated nets provides added protection against malaria compared with insecticide-treated nets alone. Am J Trop Med Hyg. 2011 Dec;85(6):1080-6. doi: 10.4269/ajtmh.2011.10-0684.
PubMed 22144448Hill N, Zhou HN, Wang P, Guo X, Carneiro I, Moore SJ. A household randomized, controlled trial of the efficacy of 0.03% transfluthrin coils alone and in combination with long-lasting insecticidal nets on the incidence of Plasmodium falciparum and Plasmodium vivax malaria in Western Yunnan Province, China. Malar J. 2014 May 31;13:208. doi: 10.1186/1475-2875-13-208.
PubMed 24885993Kawada H, Temu EA, Minjas JN, Matsumoto O, Iwasaki T, Takagi M. Field evaluation of spatial repellency of metofluthrin-impregnated plastic strips against Anopheles gambiae complex in Bagamoyo, coastal Tanzania. J Am Mosq Control Assoc. 2008 Sep;24(3):404-9. doi: 10.2987/5743.1.
PubMed 18939693Lucas JR, Shono Y, Iwasaki T, Ishiwatari T, Spero N, Benzon G. U.S. laboratory and field trials of metofluthrin (SumiOne) emanators for reducing mosquito biting outdoors. J Am Mosq Control Assoc. 2007 Mar;23(1):47-54. doi: 10.2987/8756-971X(2007)23[47:ULAFTO]2.0.CO;2.
PubMed 17536367Morrison AC, Reiner RC Jr, Elson WH, Astete H, Guevara C, Del Aguila C, Bazan I, Siles C, Barrera P, Kawiecki AB, Barker CM, Vasquez GM, Escobedo-Vargas K, Flores-Mendoza C, Huaman AA, Leguia M, Silva ME, Jenkins SA, Campbell WR, Abente EJ, Hontz RD, Paz-Soldan VA, Grieco JP, Lobo NF, Scott TW, Achee NL. Efficacy of a spatial repellent for control of Aedes-borne virus transmission: A cluster-randomized trial in Iquitos, Peru. Proc Natl Acad Sci U S A. 2022 Jun 28;119(26):e2118283119. doi: 10.1073/pnas.2118283119. Epub 2022 Jun 23.
PubMed 35737833Ogoma SB, Moore SJ, Maia MF. A systematic review of mosquito coils and passive emanators: defining recommendations for spatial repellency testing methodologies. Parasit Vectors. 2012 Dec 7;5:287. doi: 10.1186/1756-3305-5-287.
PubMed 23216844Syafruddin D, Asih PBS, Rozi IE, Permana DH, Nur Hidayati AP, Syahrani L, Zubaidah S, Sidik D, Bangs MJ, Bogh C, Liu F, Eugenio EC, Hendrickson J, Burton T, Baird JK, Collins F, Grieco JP, Lobo NF, Achee NL. Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2020 Jul;103(1):344-358. doi: 10.4269/ajtmh.19-0554. Epub 2020 May 14.
PubMed 32431275Nakyaze E, Van Hulle S, Hembling J, Arinaitwe E, Mbodji M, Alwano MG, Lamwaka FC, Tukwasibwe S, Gonahasa S, Liu F, Grieco JP, Achee NL. Advancing spatial repellents for malaria control: effectiveness and cost-effectiveness of a spatial repellent under operational use in Northern Uganda-study protocol for a cluster randomized controlled trial. Trials. 2024 Aug 22;25(1):555. doi: 10.1186/s13063-024-08378-1.
PubMed 39175062
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Spatial Repellents for Malaria Control: Effectiveness and Cost-Effectiveness of a Spatial Repellent Under Operational Use in Northern Uganda
- ClinicalTrials.gov ID
- NCT06122142
- Acronym / sponsor ID
- AEGIS Uganda / 23-05-7909
- Conditions
- Malaria
- Keywords
- Malaria, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors, Incidence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funder stop request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- S.C. Johnson & Son, Inc., Catholic Relief Services, Infectious Diseases Research Collaboration, Uganda
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 8 Nov 2023 (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 primary objective of the study is to demonstrate and quantify the effectiveness of a spatial repellent (SR) product, in reducing malaria infection in humans under operational program conditions in a humanitarian assistance context. The design will be a cluster Randomized Control Trial (cRCT) representing an operational research study.
Detailed description
Spatial repellents (SRs) have been widely used for the prevention of mosquito bites, and preliminary findings suggest efficacy against both malaria and Aedes-borne viruses but their effectiveness in reducing mosquito borne diseases under operational use has never been evaluated. SRs have the potential of being critical tools in the prevention of mosquito borne diseases in contexts where typical vectors control strategies, such as Insecticide-Treated Nets (ITNs) and indoor residual spray (IRS), are inaccessible or underutilized such as among displaced peoples or in emergency relief settings. To address this knowledge gap, the Bidibidi refugee settlement in the Yumbe District of North West Uganda was selected as the study site to estimate the impact of the SR on malaria related outcomes under operational use conditions given ongoing humanitarian relief efforts. Children will be enrolled in 3 separate cohorts to establish effectiveness of SRs in reducing malaria infection in distribution channels. One cohort will estimate the direct effect of the SR distributed through a reference channel (study personnel distribution). The two remaining cohorts will estimate the protection of the SR distributed through a voucher channel and village health team (VHT) channel. Cohorts will be followed twice a month (approximately every 15 days) during the first scheduled household visit in the month, a blood sample will be taken for malaria rapid diagnostic test (RDT) (Monthly Visit #1); and, during the second scheduled household visit, a blood sample will only be taken if the participant has a recent history of fever (Monthly Visit #2). The incidence of malaria in each cohort will be estimated and compared to the reference cohort to determine the benefit of using an SR in an area with high, year-round transmission of malaria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study design will be a prospective cluster Randomized Control Trial (cRCT)
| Arm | Type | Receives |
|---|---|---|
| Study personnel distribution channel | Active comparator | Device: Transfluthrin - delivery by paid study personnelSR product will be delivered by paid study personnel. |
| Voucher distribution channel | Experimental | Device: Transfluthrin - delivery by voucher systemVoucher which will be used to redeem for SR product(s) on a monthly basis for each head of household. |
| Village health team distribution channel | Experimental | Device: Transfluthrin - delivery by village health teamsVillage health teams will distribute SR products. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children ≥ 6 months to ≤ 59 months
- Children ≥ 6 months to ≤ 59 months with Hb > 7g/dL and no other serious illness
- Sleeps in cluster (i.e. study area) ≥ 90% of nights during any given month
- Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the Trial
- Provision of informed consent form (ICF) signed by the parent(s) or guardian
Key exclusion criteria (5 listed)
- Children < 6 months and > 59 months
- Children ≥ 6 months to ≤ 59 months with Hb ≤ 7g/dL with signs of other serious illness or Hb ≤ 7 g/dL with signs of clinical decompensation
- Sleeps in cluster (i.e. study area) < 90% of nights during any given month
- Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- No provision of ICF signed by the parent(s) or guardian
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 |
|---|---|---|
| Transfluthrin - delivery by paid study personnelPassive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel | Device | Study personnel distribution channel |
| Transfluthrin - delivery by voucher systemPassive emanator with formulated transfluthrin, voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household. | Device | Voucher distribution channel |
| Transfluthrin - delivery by village health teamsPassive emanator with formulated transfluthrin, village health teams will distribute SR products. | Device | Village health team distribution channel |
Primary outcome
Effectiveness of SR against malaria infection (both first-time and recurrent).
Time frame: 12 months
Measured by rapid diagnostic tests in children aged between 6 months to 59 months.
2 secondary outcomes
Cost-effectiveness of SR distribution.
Time frame: 12 months
Adverse Events and Serious Adverse Events.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Background: PubMed 22583679Achee NL, Bangs MJ, Farlow R, Killeen GF, Lindsay S, Logan JG, Moore SJ, Rowland M, Sweeney K, Torr SJ, Zwiebel LJ, Grieco JP. Spatial repellents: from discovery and development to evidence-based validation. Malar J. 2012 May 14;11:164. doi: 10.1186/1475-2875-11-164.
- BackgroundThe Republic of Uganda Ministry of Health. Annual Health Sector Performance Report Financial Year 2021/22. Ministry of Health, Uganda.
- BackgroundUganda National Malaria Control Division (NMCD), Uganda Bureau of Statistics (UBOS), and ICF. 2019. 2018-19 Uganda Malaria Indicator Survey Atlas of Key Indicators. Kampala, Uganda, and Rockville, Maryland, USA: NMCD, UBOS, and ICF.
- BackgroundWorld Health Organization. Twelfth meeting of the WHO Vector Control Advisory Group. Geneva: World Health Organization; 2020.
- Results publication: PubMed 22144448Hamel MJ, Otieno P, Bayoh N, Kariuki S, Were V, Marwanga D, Laserson KF, Williamson J, Slutsker L, Gimnig J. The combination of indoor residual spraying and insecticide-treated nets provides added protection against malaria compared with insecticide-treated nets alone. Am J Trop Med Hyg. 2011 Dec;85(6):1080-6. doi: 10.4269/ajtmh.2011.10-0684.
- Results publication: PubMed 24885993Hill N, Zhou HN, Wang P, Guo X, Carneiro I, Moore SJ. A household randomized, controlled trial of the efficacy of 0.03% transfluthrin coils alone and in combination with long-lasting insecticidal nets on the incidence of Plasmodium falciparum and Plasmodium vivax malaria in Western Yunnan Province, China. Malar J. 2014 May 31;13:208. doi: 10.1186/1475-2875-13-208.
- Results publication: PubMed 18939693Kawada H, Temu EA, Minjas JN, Matsumoto O, Iwasaki T, Takagi M. Field evaluation of spatial repellency of metofluthrin-impregnated plastic strips against Anopheles gambiae complex in Bagamoyo, coastal Tanzania. J Am Mosq Control Assoc. 2008 Sep;24(3):404-9. doi: 10.2987/5743.1.
- Results publication: PubMed 17536367Lucas JR, Shono Y, Iwasaki T, Ishiwatari T, Spero N, Benzon G. U.S. laboratory and field trials of metofluthrin (SumiOne) emanators for reducing mosquito biting outdoors. J Am Mosq Control Assoc. 2007 Mar;23(1):47-54. doi: 10.2987/8756-971X(2007)23[47:ULAFTO]2.0.CO;2.
- Results publication: PubMed 35737833Morrison AC, Reiner RC Jr, Elson WH, Astete H, Guevara C, Del Aguila C, Bazan I, Siles C, Barrera P, Kawiecki AB, Barker CM, Vasquez GM, Escobedo-Vargas K, Flores-Mendoza C, Huaman AA, Leguia M, Silva ME, Jenkins SA, Campbell WR, Abente EJ, Hontz RD, Paz-Soldan VA, Grieco JP, Lobo NF, Scott TW, Achee NL. Efficacy of a spatial repellent for control of Aedes-borne virus transmission: A cluster-randomized trial in Iquitos, Peru. Proc Natl Acad Sci U S A. 2022 Jun 28;119(26):e2118283119. doi: 10.1073/pnas.2118283119. Epub 2022 Jun 23.
- Results publication: PubMed 23216844Ogoma SB, Moore SJ, Maia MF. A systematic review of mosquito coils and passive emanators: defining recommendations for spatial repellency testing methodologies. Parasit Vectors. 2012 Dec 7;5:287. doi: 10.1186/1756-3305-5-287.
- Results publication: PubMed 32431275Syafruddin D, Asih PBS, Rozi IE, Permana DH, Nur Hidayati AP, Syahrani L, Zubaidah S, Sidik D, Bangs MJ, Bogh C, Liu F, Eugenio EC, Hendrickson J, Burton T, Baird JK, Collins F, Grieco JP, Lobo NF, Achee NL. Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2020 Jul;103(1):344-358. doi: 10.4269/ajtmh.19-0554. Epub 2020 May 14.
- Derived from this study: PubMed 39175062Nakyaze E, Van Hulle S, Hembling J, Arinaitwe E, Mbodji M, Alwano MG, Lamwaka FC, Tukwasibwe S, Gonahasa S, Liu F, Grieco JP, Achee NL. Advancing spatial repellents for malaria control: effectiveness and cost-effectiveness of a spatial repellent under operational use in Northern Uganda-study protocol for a cluster randomized controlled trial. Trials. 2024 Aug 22;25(1):555. doi: 10.1186/s13063-024-08378-1.
- Individual participant dataSharing planned: Yes. Analytical data will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.
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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.
John P Grieco, Ph.D. study director
University of Notre Dame
Suzanne Van Hulle, M.H.S. principal investigator
Catholic Relief Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfluthrin - delivery by paid study personnel, Transfluthrin - delivery by voucher system and Transfluthrin - delivery by village health teams in people with Malaria, run by University of Notre Dame at 2 sites in Uganda.
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: withdrawn, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of SR against malaria infection (both first-time and recurrent). (time frame: 12 months). 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 NCT06122142, which also lists 12 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 7 Mar 2025.