Malaria,FalciparumNCT04864444
Mass Drug Administration of Dihydroartemisinin-piperaquine + Single Low-dose Primaquine to Accelerate Toward Elimination Activities
A study testing Dihydroartemisinin-piperaquine and Primaquine in people with Malaria,Falciparum and Malaria, run by University of California, San Francisco at 1 site in Senegal.
Trial summary
This community-based cluster randomized controlled trial aims to evaluate the effectiveness of time-limited, community-wide mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHA-PPQ) and single low-dose primaquine (SLD-PQ) on Plasmodium falciparum transmission compared to standard-of-care seasonal… Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum, Malaria
- What is being tested?
- Dihydroartemisinin-piperaquine and Primaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,715 participants
- Where
- 1 siteSenegal
- Study dates
- 19 Jun 2021to 30 Jun 2023
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥3 months
- Willingness to comply with trial procedures and written informed consent to be obtained at the beginning of the study
Who cannot join
- Severe illness or self-reported chronic illness (e.g., HIV, tuberculosis, heart/liver/kidney disease, and severe malnutrition)
- Known hypersensitivity to study drug
- Additional exclusion criteria for DHA-PPQ:
- First trimester pregnancy assessed by history and/or urine pregnancy testing
- Concurrent artemisinin-based combination therapy (ACT) use
- Taking drugs that influence cardiac function or prolong QTc interval
Show all 9Show fewer
- Additional exclusion criteria for PQ:
- Pregnancy (any trimester) or currently breastfeeding an infant <6 months of age assessed by history and/or urine pregnancy testing
- <2 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mass Drug Administration With Dihydroartemisinin-piperaquine and Primaquine to Reduce Malaria in a Moderate-low Transmission Setting in Senegal: A Cluster Randomized Controlled Trial
This community-based cluster randomized controlled trial aims to evaluate the effectiveness of time-limited, community-wide mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHA-PPQ) and single low-dose primaquine (SLD-PQ) on Plasmodium falciparum transmission compared to standard-of-care seasonal malaria chemoprevention (SMC). The study will be conducted in a moderate-to-low malaria transmission setting of Senegal with optimized malaria control measures (e.g., proactive community case management and piperonyl butoxide pyrethroid long-lasting insecticidal nets (PBO LLINS)).
Read the detailed description
Over the past two decades in Senegal, the scale-up of malaria control measures [e.g., access to prompt testing and case management, LLINs, and SMC] has led to a 78% reduction in malaria incidence. However, gains have not been uniform, with lower transmission areas in the north implementing pre-elimination activities and higher transmission areas in the south implementing control interventions (including SMC). The purpose of this study is determine whether MDA will be able to rapidly reduce malaria incidence in areas of moderate-to-low malaria transmission of southern Senegal (where control activities are ongoing) so that the program can reorient their malaria strategy to implement elimination interventions in these settings.
The study aims to deliver three rounds of community-wide MDA with DHA-PPQ + SLD-PQ. MDA drugs will be administered over the course of three days. All three doses of DHA-PPQ will be given via supervised DOT (as per administration of SMC by national malaria guidelines) through a door-to-door approach.
The research objectives are:
- To evaluate the impact of three rounds of MDA with DHA-PPQ and SLD-PQ on village-level confirmed malaria case incidence, malaria prevalence, and on reaching a target malaria incidence of <5 cases per 1000 person-years compared to standard-of-care SMC when provided in the context of optimized control (proactive community case management + PBO LLINs).
- To determine the cost, coverage, operational feasibility, and acceptability of three rounds of MDA with DHA-PPQ and SLD-PQ compared to standard-of-care SMC.
- To determine the impact of three rounds of MDA with DHA-PPQ and SLD-PQ compared to standard-of-care SMC on parasite population dynamics and drug resistance.
- Conditions
- Malaria,Falciparum, Malaria
- Being tested
- Dihydroartemisinin-piperaquine, Primaquine
- Keywords
- Antimalarials, Mass drug administration, Dihydroartemsinin, Piperaquine, Primaquine, Parasitic Diseases
- Medical subject headings
- Malaria, Falciparum, Malaria, Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquineDrug
Also called Duo-Cotecxin
DHA-PPQ will be given over the course of three consecutive days using 160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets. DHA-PPQ will be administered via age-based dosing. All three doses will be directly observed and given orally with water and without food.
PrimaquineDrug
Primaquine will be given once with the first dose of DHA-PPQ. Primaquine will be administered in an aqueous solution according to age-based dosing guidelines.
| Study group | Role | What they receive |
|---|---|---|
| MDA with DHA-PPQ + SLD-PQ | Experimental | Participants in intervention villages will be given three rounds of MDA with DHA-PPQ and SLD-PQ. Prior to the intervention, participants will have received piperonyl butoxide (PBO) treated LLINs and proactive community case management. Unlike control villages, MDA-randomized villages will not receive SMC. Receives: Drug: Dihydroartemisinin-piperaquine; Drug: Primaquine |
| Standard malaria control interventions | No intervention | Participants in the control villages will receive standard malaria control interventions as implemented by the Senegal PNLP. This will include the distribution of PBO LLINs, proactive case management, and SMC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in village-level confirmed incidence of malaria
Village-level malaria incidence will be defined as the number of individuals diagnosed with malaria through proactive case detection and passive malaria surveillance at the health facility-level over the total village population measured during census.
Measured: one year post-MDA
Secondary outcomes (5)
Difference in parasite prevalence by microscopy during high malaria transmission season
Parasite prevalence will be assessed via microscopy from samples obtained during cross-sectional survey conducted at the end of the transmission season.
Measured: 3 months after last round of MDA
Difference in parasite prevalence by polymerase chain reaction (PCR) during high malaria transmission season
Parasite prevalence will be assessed via polymerase chain reaction from samples obtained during cross-sectional survey conducted at the end of the transmission season.
Measured: 3 months after last round of MDA
Difference in serological markers of recent infection
Difference in seroprevalence from samples obtained during cross-sectional survey conducted at the end of the transmission season.
Measured: 3 months after last round of MDA
Difference in the change in prevalence of drug resistance markers
Prevalence of drug resistance markers (K13 and plasmepsin copy number) will be assessed from samples taken during the baseline and endline cross-sectional surveys.
Measured: Change from baseline to endline; 1 year period
Difference in the change in prevalence of parasite population dynamics
Prevalence of parasite population dynamics (multiplicity of infection) will be assessed from samples taken during the baseline and endline cross-sectional surveys.
Measured: Change from baseline to endline; 1 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start19 Jun 2021
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
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.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm cluster randomized controlled trial. A total of 60 villages will be randomized to receive the intervention (three rounds of MDA with DHA-PPQ + SLD-PQ) or control (standard malaria control measures, including SMC) at a ratio of 1:1
- Masking
- None (open label)
- Enrolment
- 10,715 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- L'université de Thiès, Programme National de Lutte contre le Paludisme, Niger, Population Services International, Centers for Disease Control and Prevention, US President's Malaria Initiative
- Responsible party
- Sponsor
- Investigators
- Jean Louis Ndiaye, MD PhD, Principal investigator, Université de ThièsMichelle Hsiang, MD MSc, Principal investigator, University of California, San FranciscoDoudou Séne, MD, Principal investigator, Senegal Programme National de Lutte contre le Paludisme (PNLP)Katharine Sturm-Ramirez, PhD, Principal investigator, US President's Malaria Initiative/CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864444
- Sponsor's protocol ID
- 20-29886
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ba EKC, Roh ME, Diallo A, Gadiaga T, Seck A, Thiam S, Fogelson A, Gaye S, Diallo I, Lo AC, Diouf E, Ba OG, Gueye AB, Wu X, Milligan P, Kibuka T, Hama M, Eckert E, Thwing J, Bennett A, Gosling R, Hwang J, Sene D, Ba F, Cisse B, Sturm-Ramirez K, Hsiang MS, Ndiaye JL. Effect of mass drug administration on malaria incidence in southeast Senegal during 2020-22: a two-arm, open-label, cluster-randomised controlled trial. Lancet Infect Dis. 2025 Jun;25(6):656-667. doi: 10.1016/S1473-3099(24)00741-2. Epub 2025 Jan 9.
PubMed 39799956Ba Konko Cire EH, Roh ME, Diallo A, Gadiaga T, Seck A, Thiam S, Gaye S, Diallo I, Lo AC, Diouf E, Ba OG, Gueye AB, Fogelson A, Wu X, Milligan P, Kibuka T, Hama M, Eckert E, Thwing J, Bennett A, Gosling R, Hwang J, Sene D, Ba F, Cisse B, Sturm-Ramirez K, Hsiang MS, Ndiaye JL. Mass drug administration to reduce malaria incidence in a low-to-moderate endemic setting: short-term impact results from a cluster randomised controlled trial in Senegal. medRxiv [Preprint]. 2024 Jul 18:2024.07.17.24310593. doi: 10.1101/2024.07.17.24310593.
PubMed 39072042
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Drug Administration With Dihydroartemisinin-piperaquine and Primaquine to Reduce Malaria in a Moderate-low Transmission Setting in Senegal: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04864444
- Acronym / sponsor ID
- 20-29886
- Conditions
- Malaria,Falciparum, Malaria
- Keywords
- Antimalarials, Mass drug administration, Dihydroartemsinin, Piperaquine, Primaquine, Parasitic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,715 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- L'université de Thiès, Programme National de Lutte contre le Paludisme, Niger, Population Services International, Centers for Disease Control and Prevention, US President's Malaria Initiative
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 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 community-based cluster randomized controlled trial aims to evaluate the effectiveness of time-limited, community-wide mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHA-PPQ) and single low-dose primaquine (SLD-PQ) on Plasmodium falciparum transmission compared to standard-of-care seasonal malaria chemoprevention (SMC). The study will be conducted in a moderate-to-low malaria transmission setting of Senegal with optimized malaria control measures (e.g., proactive community case management and piperonyl butoxide pyrethroid long-lasting insecticidal nets (PBO LLINS)).
Detailed description
Over the past two decades in Senegal, the scale-up of malaria control measures [e.g., access to prompt testing and case management, LLINs, and SMC] has led to a 78% reduction in malaria incidence. However, gains have not been uniform, with lower transmission areas in the north implementing pre-elimination activities and higher transmission areas in the south implementing control interventions (including SMC). The purpose of this study is determine whether MDA will be able to rapidly reduce malaria incidence in areas of moderate-to-low malaria transmission of southern Senegal (where control activities are ongoing) so that the program can reorient their malaria strategy to implement elimination interventions in these settings.
The study aims to deliver three rounds of community-wide MDA with DHA-PPQ + SLD-PQ. MDA drugs will be administered over the course of three days. All three doses of DHA-PPQ will be given via supervised DOT (as per administration of SMC by national malaria guidelines) through a door-to-door approach.
The research objectives are:
- To evaluate the impact of three rounds of MDA with DHA-PPQ and SLD-PQ on village-level confirmed malaria case incidence, malaria prevalence, and on reaching a target malaria incidence of <5 cases per 1000 person-years compared to standard-of-care SMC when provided in the context of optimized control (proactive community case management + PBO LLINs).
- To determine the cost, coverage, operational feasibility, and acceptability of three rounds of MDA with DHA-PPQ and SLD-PQ compared to standard-of-care SMC.
- To determine the impact of three rounds of MDA with DHA-PPQ and SLD-PQ compared to standard-of-care SMC on parasite population dynamics and drug resistance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm cluster randomized controlled trial. A total of 60 villages will be randomized to receive the intervention (three rounds of MDA with DHA-PPQ + SLD-PQ) or control (standard malaria control measures, including SMC) at a ratio of 1:1
| Arm | Type | Receives |
|---|---|---|
| MDA with DHA-PPQ + SLD-PQ | Experimental | Drug: Dihydroartemisinin-piperaquine, Drug: PrimaquineParticipants in intervention villages will be given three rounds of MDA with DHA-PPQ and SLD-PQ. Prior to the intervention, participants will have received piperonyl butoxide (PBO) treated LLINs and proactive community case management. Unlike control villages, MDA-randomized villages will not receive SMC. |
| Standard malaria control interventions | No intervention | –Participants in the control villages will receive standard malaria control interventions as implemented by the Senegal PNLP. This will include the distribution of PBO LLINs, proactive case management, and SMC. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥3 months
- Willingness to comply with trial procedures and written informed consent to be obtained at the beginning of the study
Key exclusion criteria (9 listed)
- Severe illness or self-reported chronic illness (e.g., HIV, tuberculosis, heart/liver/kidney disease, and severe malnutrition)
- Known hypersensitivity to study drug
- First trimester pregnancy assessed by history and/or urine pregnancy testing
- Concurrent artemisinin-based combination therapy (ACT) use
- Taking drugs that influence cardiac function or prolong QTc interval
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 |
|---|---|---|
| Dihydroartemisinin-piperaquineAlso: Duo-CotecxinDHA-PPQ will be given over the course of three consecutive days using 160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets. DHA-PPQ will be administered via age-based dosing. All three doses will be directly observed and given orally with water and without food. | Drug | MDA with DHA-PPQ + SLD-PQ |
| PrimaquinePrimaquine will be given once with the first dose of DHA-PPQ. Primaquine will be administered in an aqueous solution according to age-based dosing guidelines. | Drug | MDA with DHA-PPQ + SLD-PQ |
Primary outcome
Difference in village-level confirmed incidence of malaria
Time frame: one year post-MDA
Village-level malaria incidence will be defined as the number of individuals diagnosed with malaria through proactive case detection and passive malaria surveillance at the health facility-level over the total village population measured during census.
5 secondary outcomes
Difference in parasite prevalence by microscopy during high malaria transmission season
Time frame: 3 months after last round of MDA
Difference in parasite prevalence by polymerase chain reaction (PCR) during high malaria transmission season
Time frame: 3 months after last round of MDA
Difference in serological markers of recent infection
Time frame: 3 months after last round of MDA
Difference in the change in prevalence of drug resistance markers
Time frame: Change from baseline to endline; 1 year period
Difference in the change in prevalence of parasite population dynamics
Time frame: Change from baseline to endline; 1 year period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Derived from this study: PubMed 39799956Ba EKC, Roh ME, Diallo A, Gadiaga T, Seck A, Thiam S, Fogelson A, Gaye S, Diallo I, Lo AC, Diouf E, Ba OG, Gueye AB, Wu X, Milligan P, Kibuka T, Hama M, Eckert E, Thwing J, Bennett A, Gosling R, Hwang J, Sene D, Ba F, Cisse B, Sturm-Ramirez K, Hsiang MS, Ndiaye JL. Effect of mass drug administration on malaria incidence in southeast Senegal during 2020-22: a two-arm, open-label, cluster-randomised controlled trial. Lancet Infect Dis. 2025 Jun;25(6):656-667. doi: 10.1016/S1473-3099(24)00741-2. Epub 2025 Jan 9.
- Derived from this study: PubMed 39072042Ba Konko Cire EH, Roh ME, Diallo A, Gadiaga T, Seck A, Thiam S, Gaye S, Diallo I, Lo AC, Diouf E, Ba OG, Gueye AB, Fogelson A, Wu X, Milligan P, Kibuka T, Hama M, Eckert E, Thwing J, Bennett A, Gosling R, Hwang J, Sene D, Ba F, Cisse B, Sturm-Ramirez K, Hsiang MS, Ndiaye JL. Mass drug administration to reduce malaria incidence in a low-to-moderate endemic setting: short-term impact results from a cluster randomised controlled trial in Senegal. medRxiv [Preprint]. 2024 Jul 18:2024.07.17.24310593. doi: 10.1101/2024.07.17.24310593.
- Individual participant dataSharing planned: No
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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.
Jean Louis Ndiaye, MD PhD principal investigator
Université de Thiès
Michelle Hsiang, MD MSc principal investigator
University of California, San Francisco
Doudou Séne, MD principal investigator
Senegal Programme National de Lutte contre le Paludisme (PNLP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dihydroartemisinin-piperaquine and Primaquine in people with Malaria,Falciparum and Malaria, run by University of California, San Francisco at 1 site in Senegal.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jun 2024. 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 Senegal. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in village-level confirmed incidence of malaria (time frame: one year post-MDA). 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 NCT04864444, 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 Jun 2024.