An interventional study of Dihydroartemisinin-piperaquine and Primaquine in Malaria,Falciparum and Malaria, sponsored by University of California, San Francisco. Completed at 1 site in Senegal. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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)).
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:
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 10,715 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Additional exclusion criteria for DHA-PPQ:
Additional exclusion criteria for PQ:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dihydroartemisinin-piperaquine · Drug: Primaquine
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.
Drug pages: Artenimol · Piperaquine
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.
Also known as: Duo-Cotecxin
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.
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.
Time frame: one year post-MDA
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to endline; 1 year period
Population coverage of MDA
Coverage will be measured as the proportion of people who received MDA divided by the total number of persons in the population at each MDA round.
Time frame: Up to 18 weeks
Difference in the cost-effectiveness of MDA versus SMC
Costs of MDA and optimized control will be collected throughout the study period. The incremental cost-effectiveness ratio (ICER) will be used to compare MDA to SMC.
Time frame: Up to 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Dec 2022, 18 months.
Of 24 interventional studies with no phase under Malaria, Falciparum, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 18 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Artenimol · Piperaquine · Primaquine
University of California, San Francisco →