Malaria,FalciparumPhase 4NCT06083688
Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi
A Phase 4 study testing Dihydroartemisinin-Piperaquine, Chloroquine and Sulfadoxine-pyrimethamine-amodiaquine in people with Malaria,Falciparum and Anemia in Children, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). 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, Anemia in Children
- What is being tested?
- Dihydroartemisinin-Piperaquine, Chloroquine and Sulfadoxine-pyrimethamine-amodiaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 788 participants
- Where
- 1 siteMalawi
- Study dates
- 14 Oct 2024to 14 Jan 2026
- Phase
- Phase 4
- 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
Student Inclusion Criteria:
- Currently enrolled in the study school
- Plan to attend the study school for the remainder of the school year
- Parent/guardian available to provide written informed consent
Student Exclusion Criteria:
- Current evidence of severe malaria or danger signs
- Known adverse reaction to the study drugs
- History of cardiac problems or fainting
- Taking medications known to prolong QT
- Family history of prolonged QT
- History of epilepsy or psoriasis
- Taking cotrimoxazole for long-term prophylaxis
Younger child Inclusion Criteria
- Slept in the household for most nights in the last month
- Age 6-59 months
- Parent/guardian available to provide written informed consent
Younger child Exclusion Criteria
- Current evidence of severe malaria or danger signs
Trial locations and contacts
1 site in 1 country.
About this study
This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.
Read the detailed description
Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.
- Conditions
- Malaria,Falciparum, Anemia in Children
- Being tested
- Dihydroartemisinin-Piperaquine, Chloroquine, Sulfadoxine-pyrimethamine-amodiaquine
- Keywords
- IPTsc, school, chemoprevention, intermittent preventive treatment, malaria transmission
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-PiperaquineDrug
Also called DP, D-Artepp, DuoCotecxin, Artekin
Treatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older).
ChloroquineDrug
Also called Aralen, Hydroxychloroquine, Lariago
Treatment will be with CQ alone if female and 13 years old or older in both intervention arms.
Sulfadoxine-pyrimethamine-amodiaquineDrug
Also called SPAQ, SPAQ-Co
Treatment in Arm 2 (females less than 13 years old and all males).
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP) | Experimental | All students are treated at each intervention. Treatment will be with DP (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Receives: Drug: Dihydroartemisinin-Piperaquine; Drug: Chloroquine |
| Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ) | Experimental | All students are treated at each intervention. Treatment will be with SP and AQ (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Receives: Drug: Chloroquine; Drug: Sulfadoxine-pyrimethamine-amodiaquine |
| Control | No intervention | Students will not receive preventive treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with P. falciparum infection
detected by polymerase chain reaction (PCR, binary)
Measured: 6-8 weeks after the last intervention
Number of participants with anemia
World Health Organization age-sex definitions (binary)
Measured: 6-8 weeks after the last intervention
Rate of clinical malaria
cumulative incidence
Measured: through study completion (approximately 6 months), and 6 months following the intervention
Secondary outcomes (6)
Mean hemoglobin concentration
g/dL (continuous)
Measured: 6-8 weeks after the last intervention
Literacy skills
Early grade reading assessment
Measured: 6-8 weeks after the last intervention
Math skills
Early grade math assessment
Measured: 6-8 weeks after the last intervention
Rate of school absenteeism among participants
Proportion of days absent among days where attendance is assessed
Measured: through study completion (approximately 6 months)
P. falciparum prevalence among children less than 5 years old living in households with study participants
detected by PCR
Measured: 6-8 weeks after the last intervention
Rate of clinical malaria among children less than 5 years old living in households with study participants
cumulative incidence
Measured: through study completion (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start14 Oct 2024
- Primary completion31 Jul 2025
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Students will be randomized to three arms Arm 1: intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTsc-DP); Arm 2: intermittent preventive treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPTsc-SPAQ); Arm 3 the control arm. Females 13 years and older (likely post-menarche) in Arms 1 and 2 will receive chloroquine alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083688
- Sponsor's protocol ID
- 23-048
- Status last verified
- Jul 2026
- First submitted
- 9 Oct 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi
- ClinicalTrials.gov ID
- NCT06083688
- Acronym / sponsor ID
- 23-048
- Conditions
- Malaria,Falciparum, Anemia in Children
- Keywords
- IPTsc, school, chemoprevention, intermittent preventive treatment, malaria transmission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 788 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 16 Oct 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.
This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.
Detailed description
Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Students will be randomized to three arms Arm 1: intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTsc-DP); Arm 2: intermittent preventive treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPTsc-SPAQ); Arm 3 the control arm. Females 13 years and older (likely post-menarche) in Arms 1 and 2 will receive chloroquine alone.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP) | Experimental | Drug: Dihydroartemisinin-Piperaquine, Drug: ChloroquineAll students are treated at each intervention. Treatment will be with DP (females less than 13 years old and all males) or chloroquine (females 13 years old or older). |
| Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ) | Experimental | Drug: Chloroquine, Drug: Sulfadoxine-pyrimethamine-amodiaquineAll students are treated at each intervention. Treatment will be with SP and AQ (females less than 13 years old and all males) or chloroquine (females 13 years old or older). |
| Control | No intervention | –Students will not receive preventive treatment. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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: DP, D-Artepp, DuoCotecxin, ArtekinTreatment will be with DP (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). | Drug | Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP) |
| ChloroquineAlso: Aralen, Hydroxychloroquine, LariagoTreatment will be with CQ alone if female and 13 years old or older in both intervention arms. | Drug | Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP), Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ) |
| Sulfadoxine-pyrimethamine-amodiaquineAlso: SPAQ, SPAQ-CoTreatment in Arm 2 (females less than 13 years old and all males). | Drug | Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ) |
Primary outcome
Number of participants with P. falciparum infection
Time frame: 6-8 weeks after the last intervention
detected by polymerase chain reaction (PCR, binary)
Number of participants with anemia
Time frame: 6-8 weeks after the last intervention
World Health Organization age-sex definitions (binary)
Rate of clinical malaria
Time frame: through study completion (approximately 6 months), and 6 months following the intervention
cumulative incidence
6 secondary outcomes
Mean hemoglobin concentration
Time frame: 6-8 weeks after the last intervention
Literacy skills
Time frame: 6-8 weeks after the last intervention
Math skills
Time frame: 6-8 weeks after the last intervention
Rate of school absenteeism among participants
Time frame: through study completion (approximately 6 months)
P. falciparum prevalence among children less than 5 years old living in households with study participants
Time frame: 6-8 weeks after the last intervention
Rate of clinical malaria among children less than 5 years old living in households with study participants
Time frame: through study completion (approximately 6 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 30 Jul 2026.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication
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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 Phase 4 study testing Dihydroartemisinin-Piperaquine, Chloroquine and Sulfadoxine-pyrimethamine-amodiaquine in people with Malaria,Falciparum and Anemia in Children, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Jul 2026. 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 Malawi. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants with P. falciparum infection (time frame: 6-8 weeks after the last intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.