MalariaSMC-DPNCT05874869
Dihydroartemisinin-piperaquine for Seasonal Malaria Chemoprophylaxis in Tanzania
A study testing Dihydroartemisinin-piperaquine in people with Malaria and Chemoprophylaxis, run by Richard Mwaiswelo at 1 site in Tanzania.
Trial summary
Background: Malaria prevalence has declined globally following the scale-up of the interventions, including insecticide-treated bed-net, indoor residual spraying, and prompt diagnosis and treatment with artemisinin-based combination therapy (ACT). Read more about this study
- Who is it for?
- Ages 3 to 59 months
- Conditions the study is for
- Malaria, Chemoprophylaxis, Underfive Children
- What is being tested?
- Dihydroartemisinin-piperaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,800 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Jul 2020to 30 Jun 2021
- 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 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being afebrile,
- willing to participate in the trial, and
- the ability to swallow oral medications.
Who cannot join
- a presence of an acute febrile illness or severe illness that impairs the ability to take oral medication
- HIV-positive child receiving cotrimoxazole prophylaxis,
- a child who has received a dose of antimalarial drug including dihydroartemisinin-piperaquine during the past month; and
- a history of allergy to DHA-PQ.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Ssciences
Dar es Salaam, 65001
About this study
Official title: Effectiveness of Dihydroartemisinin-piperaquine as Seasonal Malaria Chemoprophylaxis in Extended High Transmission Settings of Tanzania: an Open Cluster Randomized Clinical Trial.
Background: Malaria prevalence has declined globally following the scale-up of the interventions, including insecticide-treated bed-net, indoor residual spraying, and prompt diagnosis and treatment with artemisinin-based combination therapy (ACT). Despite the gained success in the control, malaria has remained a major public health problem, particularly affecting children aged < 5 years in sub-Saharan Africa. Most of the malaria transmissions occur during the rainy season, a relatively short period. Intervention using antimalarial chemotherapy in children during the transmission season has been shown to prevent malaria-related morbidity and mortality. The World Health Organization has recommended seasonal malaria chemoprevention (SMC) using Sulphadoxine-pyrimethamine (SP) plus amodiaquine (AQ) in children aged 3-59 months in areas with highly seasonal malaria transmission. However, SP-AQ resistance is widespread in Tanzania. Therefore, this study will assess the effectiveness of Dihydroartemisinin-piperaquine (DHA-PQ) as SMC for the control of malaria among children in Tanzania.
Methods: Afebrile children aged 3-59 months from Nanyumbu and Masasi districts in the Mtwara region will be enrolled in an open cluster randomized clinical trial, administered monthly with a full course of DHA-PQ for three or four consecutive months during the high malaria transmission season of the three consecutive years. Three approaches of DHA-PQ SMC administration will be tested; a door-to-door approach using community health workers (CHWs), outreach visits using local health facilities clinicians/nurses, and village health posts using selected CHWs. Study participants will then be followed-up to evaluate the impact of the intervention on all-course of malaria morbidity and mortality; adverse events associated with the intervention; acceptability, adherence, coverage, and cost-effectiveness of the intervention; treatment-seeking behavior; and the risk of rebound after the withdrawal of the intervention. The primary outcome will be a prevalence of clinical malaria defined as the presence of fever (axillary temperature of 37.5 degrees Celsius) or a history of fever in the past 24 hours and the presence of P. falciparum asexual parasitemia at any density.
Read more
Findings: The findings will be disseminated through community meetings, seminars, local and international conferences, and publication in international journals.
Impact: The findings from this study will provide information on the effectiveness of DHA-PQ for seasonal prevention of malaria morbidity and mortality in children aged < 5 years in Tanzania.
- Conditions
- Malaria, Chemoprophylaxis, Underfive Children
- Being tested
- Dihydroartemisinin-piperaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquineDrug
The drug will be administered once a day for three consecutive days for three months (March, April, and May)
| Study group | Role | What they receive |
|---|---|---|
| Dihydroartemisinin-piperaquine | Active comparator | Dihydroartemisinin-piperaquine will be administered to the intervention arm Receives: Drug: Dihydroartemisinin-piperaquine |
| Control | No intervention | Individuals that will get malaria infection and present at the health facility with clinical signs and symptoms will be treated according to the Tanzania National Malaria Treatment guidelines using artemether-lumefantrine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of clinical malaria
Defined as the presence of any malaria-related signs/symptoms plus P. falciparum asexual parasitemia at any density. For it to be considered a clinical malaria there must be any signs or symptoms related to malaria infection and the presence of asexual P. falciparum parasites confirmed by mRDT or microscopy.
Measured: 12 months
Secondary outcomes (7)
Incidence of severe malaria
Defined according to the WHO criteria
Measured: 12 months
Prevalence of malaria infection
Defined as the presence of asexual parasitemia. Individuals do not show any signs or symptoms related to malaria infection but they have asexual P. falciparum parasites confirmed by mRDT or microscopy.
Measured: 12 months
Prevalence of anaemia
Prevalence of mild, moderate, or severe anaemia defined as an hemoglobin concentration of 11 g/dL, 8 g/dL, or 5 g/dL, respectively.
Measured: 12 months
Prevalence of hospital admissions
Prevalence of individuals admitted to the health facility due to malaria infection during the SMC will be assessed. Hospital admission will be defined as a stay of at least 24 hours in hospital for treatment.
Measured: 12 months
Prevalence of participants with any anthropometric indices.
The prevalence of children with anthropometric indices including wasting, stunting, or underweight as defined by WHO will be assessed before and after the three rounds of SMC and then compared.
Measured: 12 months
Prevalence of household heads with positive health seeking behavior
Initiatives to seek treatment once feels sick. A questionnainne will be used to gather information from the household heads of the children involved in the study on what initiatives do they take when they or their children become sick.
Measured: 12 months
Prevalence of molecular markers
Molecular markers of artemisinin and partner drugs resistance.
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 posted25 May 2023
- Study start1 Jul 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- None (open label)
- Enrolment
- 13,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Mwaiswelo
- Sponsor type
- Other government
- Collaborators
- Muhimbili University of Health and Allied Sciences, National Institute for Medical Research, Tanzania, Hubert Kairuki Memorial University
- Responsible party
- Sponsor-investigator, Richard Mwaiswelo, Tropical Pesticides Research Institute, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874869
- Sponsor's protocol ID
- MUHAS-REC-10-2019-062
- Acronym
- SMC-DP
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with individuals locally and globally following guidelines stipulated in the Data and Material Transfer Agreement.
Publications
Mwaiswelo R, Ngasala B, Chaky F, Molteni F, Mohamed A, Lazaro S, Samwel B, Mmbando BP. Dihydroartemisinin-piperaquine effectiveness for seasonal malaria chemoprevention in settings with extended seasonal malaria transmission in Tanzania. Sci Rep. 2024 Jan 25;14(1):2143. doi: 10.1038/s41598-024-52706-z.
PubMed 38273019
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dihydroartemisinin-piperaquine as Seasonal Malaria Chemoprophylaxis in Extended High Transmission Settings of Tanzania: an Open Cluster Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05874869
- Acronym / sponsor ID
- SMC-DP / MUHAS-REC-10-2019-062
- Conditions
- Malaria, Chemoprophylaxis, Underfive Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,800 participants (actual)
- Lead sponsor
- Richard MwaisweloOther government
- Collaborators
- Muhimbili University of Health and Allied Sciences, National Institute for Medical Research, Tanzania, Hubert Kairuki Memorial University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 May 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.
Background: Malaria prevalence has declined globally following the scale-up of the interventions, including insecticide-treated bed-net, indoor residual spraying, and prompt diagnosis and treatment with artemisinin-based combination therapy (ACT). Despite the gained success in the control, malaria has remained a major public health problem, particularly affecting children aged < 5 years in sub-Saharan Africa. Most of the malaria transmissions occur during the rainy season, a relatively short period. Intervention using antimalarial chemotherapy in children during the transmission season has been shown to prevent malaria-related morbidity and mortality. The World Health Organization has recommended seasonal malaria chemoprevention (SMC) using Sulphadoxine-pyrimethamine (SP) plus amodiaquine (AQ) in children aged 3-59 months in areas with highly seasonal malaria transmission. However, SP-AQ resistance is widespread in Tanzania. Therefore, this study will assess the effectiveness of Dihydroartemisinin-piperaquine (DHA-PQ) as SMC for the control of malaria among children in Tanzania.
Methods: Afebrile children aged 3-59 months from Nanyumbu and Masasi districts in the Mtwara region will be enrolled in an open cluster randomized clinical trial, administered monthly with a full course of DHA-PQ for three or four consecutive months during the high malaria transmission season of the three consecutive years. Three approaches of DHA-PQ SMC administration will be tested; a door-to-door approach using community health workers (CHWs), outreach visits using local health facilities clinicians/nurses, and village health posts using selected CHWs. Study participants will then be followed-up to evaluate the impact of the intervention on all-course of malaria morbidity and mortality; adverse events associated with the intervention; acceptability, adherence, coverage, and cost-effectiveness of the intervention; treatment-seeking behavior; and the risk of rebound after the withdrawal of the intervention. The primary outcome will be a prevalence of clinical malaria defined as the presence of fever (axillary temperature of 37.5 degrees Celsius) or a history of fever in the past 24 hours and the presence of P. falciparum asexual parasitemia at any density.
Findings: The findings will be disseminated through community meetings, seminars, local and international conferences, and publication in international journals.
Impact: The findings from this study will provide information on the effectiveness of DHA-PQ for seasonal prevention of malaria morbidity and mortality in children aged < 5 years in Tanzania.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dihydroartemisinin-piperaquine | Active comparator | Drug: Dihydroartemisinin-piperaquineDihydroartemisinin-piperaquine will be administered to the intervention arm |
| Control | No intervention | –Individuals that will get malaria infection and present at the health facility with clinical signs and symptoms will be treated according to the Tanzania National Malaria Treatment guidelines using artemether-lumefantrine. |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being afebrile,
- willing to participate in the trial, and
- the ability to swallow oral medications.
Key exclusion criteria (4 listed)
- a presence of an acute febrile illness or severe illness that impairs the ability to take oral medication
- HIV-positive child receiving cotrimoxazole prophylaxis,
- a child who has received a dose of antimalarial drug including dihydroartemisinin-piperaquine during the past month; and
- a history of allergy to DHA-PQ.
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-piperaquineThe drug will be administered once a day for three consecutive days for three months (March, April, and May) | Drug | Dihydroartemisinin-piperaquine |
Primary outcome
Prevalence of clinical malaria
Time frame: 12 months
Defined as the presence of any malaria-related signs/symptoms plus P. falciparum asexual parasitemia at any density. For it to be considered a clinical malaria there must be any signs or symptoms related to malaria infection and the presence of asexual P. falciparum parasites confirmed by mRDT or microscopy.
7 secondary outcomes
Incidence of severe malaria
Time frame: 12 months
Prevalence of malaria infection
Time frame: 12 months
Prevalence of anaemia
Time frame: 12 months
Prevalence of hospital admissions
Time frame: 12 months
Prevalence of participants with any anthropometric indices.
Time frame: 12 months
Prevalence of household heads with positive health seeking behavior
Time frame: 12 months
Prevalence of molecular markers
Time frame: 12 months
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 25 May 2023.
- Derived from this study: PubMed 38273019Mwaiswelo R, Ngasala B, Chaky F, Molteni F, Mohamed A, Lazaro S, Samwel B, Mmbando BP. Dihydroartemisinin-piperaquine effectiveness for seasonal malaria chemoprevention in settings with extended seasonal malaria transmission in Tanzania. Sci Rep. 2024 Jan 25;14(1):2143. doi: 10.1038/s41598-024-52706-z.
- Individual participant dataSharing planned: Yes. Data will be shared with individuals locally and globally following guidelines stipulated in the Data and Material Transfer Agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Malaria and Chemoprophylaxis, run by Richard Mwaiswelo at 1 site in Tanzania.
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 3 inclusion and 4 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 25 May 2023. 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 Tanzania. 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?
Prevalence of clinical malaria (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 NCT05874869, which also lists 1 linked publication.
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 25 May 2023.