Falciparum; MalariaPhase 4SPARTANNCT06347471

The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy

A Phase 4 study testing Artemether-lumefantrine and Dihydroartemisinin-Piperaquine in people with Falciparum; Malaria, run by Infectious Diseases Research Collaboration, Uganda at 2 sites in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 years and older
Conditions the study is for: Falciparum; Malaria
What is being tested?: Artemether-lumefantrine and Dihydroartemisinin-Piperaquine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 2 sitesUganda
Study dates: 28 May 2024to 22 Nov 2025
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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

age ≥2 years
blood smear positive for P. falciparum gametocytes
mono-infection with P. falciparum confirmed by positive blood smear;
parasitaemia of >100 P. falciparum asexual forms/µL;
ability to swallow oral medication;
ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
informed consent from parent or guardian;
haemoglobin ≥ 7.0 g/dl for children below 10 years of age or ≥8.0g/dL for older individuals

Who cannot join

presence of general danger signs;
mixed or mono-infection with another Plasmodium species detected by microscopy;
presence of severe malnutrition defined as a very low weight for height (below -3z scores of the median WHO growth standards), by visible severe wasting, or by the presence of nutritional oedema.
presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested

Trial locations and contacts

2 sites in 1 country.

Uganda2 sites

Dr. Ambrosoli Memorial Hospital
Kalongo, Agago District
Patongo Health Facility IV
Patongo, Agago District

Other trials in Uganda

About this study

Official title: The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy: a Longitudinal Study

A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and asymptomatically infected individuals. Participants are treated with conventional artemisinin-combination therapies (ACT) as part of standard clinical care. From this population, we will select P. falciparum gametocyte carriers.

Before, during and after ACT treatment, the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy, molecular methods, parasite culture and mosquito feeding assays. Parasite clearance will be determined in the first days (d0-3) after treatment.

The study population will consist of passively recruited patients with uncomplicated P. falciparum malaria and asymptomatically infected individuals who are microscopy positive for gametocytes. Participants will be treated with conventional therapies for uncomplicated malaria without randomization: artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA-PPQ). All doses are supervised. Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment.

Gametocyte carriage and gametocyte commitment/production will be determined for resistant and wild type infections before, during and after treatment. In addition, venous blood will be collected at three timepoints to assess transmission to mosquitoes before (d0), during (d2) and after treatment (d7). The total duration of participation will be 7 days, the primary endpoint will be the reduction in mosquito infection rates at d2 (artemether-lumefantrine) or d7 (dihydroartemisinin-piperaquine) compared to pre-treatment.

Conditions: Falciparum; Malaria
Being tested: Artemether-lumefantrine, Dihydroartemisinin-Piperaquine
Keywords: Malaria Transmission, Artemisinin resistance, Gametocytes, Spread of resistance
Medical subject headings: Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Artemether-lumefantrineDrug
Also called Coartem
Participants in the Artemether-Lumefantrine arm will be treated with standard doses of AL (Coartem, Novartis). Tablets containing 20/80 mg artemether and 120/480 mg lumefantrine will be administered per manufacturer guidelines. All doses will be given under direct supervision with fatty food.
Dihydroartemisinin-PiperaquineDrug
Also called Eurartesim, Duocotecxin
Participants in the DHA-PPQ arm will be treated with standard doses of DHA-PPQ. Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine tablets (Eurartesim, Sigma Tau or Duocotecxin, Beijing Holley-Cotect Pharmaceutical Co) will be administered per manufacturer guidelines. All doses will be given under direct supervision on an empty stomach, as per manufacturer instructions.

Study groups in NCT06347471
Study group	Role	What they receive
artemether-lumefantrine	Active comparator	artemether-lumefantrine according to manufacturer instructions Receives: Drug: Artemether-lumefantrine
dihydroartemisinin-piperaquine	Experimental	dihydroartemisinin-piperaquine according to manufacturer instructions Receives: Drug: Dihydroartemisinin-Piperaquine

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline.
Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline (day 0, pre-treatment) to day 2 post treatment in the AL and day 7 post-treatment in the DHA-PPQ arm. Infectivity is assessed by mosquito membrane feeding assays; percent reduction is calculated separately for ΔPfK13 vs wild type infections.
Measured: day 2 vs day 0 (AL arm) and day 7 vs day 0 (DP arm)

Secondary outcomes (12)

Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline
Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline to all feeding time-points. Infectivity is assessed by mosquito membrane feeding assays; comparisons are performed within treatment arms for ΔPfK13 vs wild type infections.
Measured: days 0, 2, 7
Mean oocyst intensity (in all/all infected mosquitoes)
Mean oocyst intensity (in all/all infected mosquitoes) will be assessed at all feeding time-points; comparisons are performed within treatment arms for ΔPfK13 vs wild type infections
Measured: days 0, 2, 7
Male and female gametocyte sex ratio (proportion male)
Male and female gametocyte sex ratio (proportion male) at all time-points, determined by molecular assays; comparisons are performed within treatment arms for ΔPfK13 vs wild type infections.
Measured: days 0, 1, 2, 3, 7, 14
Gametocyte circulation time
Gametocyte circulation time (cumulative), determined by microscopy or molecular assays, compared between treatment arms and between ΔPfK13 vs wild type infections
Measured: days 0, 1, 2, 3, 7, 14
Gametocyte area under the curve
Gametocyte area under the curve (cumulative), determined by microscopy or molecular assays, compared between treatment arms, and between ΔPfK13 vs wild type infections
Measured: days 0, 1, 2, 3, 7, 14
Asexual parasite prevalence
Asexual parasite prevalence at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms, between arms, and between ΔPfK13 vs wild type infections
Measured: Hours 0, 8, 16, Days 1, 2, 3, 7, 14
Asexual parasite density
Asexual parasite density at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms, between arms, and between ΔPfK13 vs wild type infections
Measured: Hours 0, 8, 16, Days 1, 2, 3, 7, 14
Total parasite prevalence
Total parasite prevalence at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms, between arms, and between ΔPfK13 vs wild type infections
Measured: Hours 0, 8, 16, Days 1, 2, 3, 7, 14
Total parasite density
Total parasite density at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms, between arms, and between ΔPfK13 vs wild type infections
Measured: Hours 0, 8, 16, Days 1, 2, 3, 7, 14
The density of ΔPfK13 vs wild type genotypes
The density of ΔPfK13 vs wild type genotypes in peripheral blood, the asexual parasite fraction and gametocyte fraction before and after initiation of treatment. The relative abundance of ΔPfK13 genotypes will be compared between pre- and post-treatment timepoints
Measured: days 0, 1, 2, 3, 7, 14
The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment
The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment. The relative abundance of ΔPfK13 genotypes will be compared between pre- and post-treatment timepoints
Measured: days 0, 2, 7
Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline after gametocyte enrichment
Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline to all feeding time-points. Infectivity is assessed by mosquito membrane feeding assays after gametocyte enrichment; comparisons are performed within treatment arms for ΔPfK13 vs wild type infections.
Measured: days 0, 2, 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 202422 Nov 2025

First posted4 Apr 2024
Study start28 May 2024
Primary completion22 Nov 2025
Study completion22 Nov 2025

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 Falciparum; 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06347471
Sponsor's protocol ID: SBS-2023-477
Acronym: SPARTAN
Status last verified: Jul 2026
First submitted: 29 Mar 2024
Last updated: 6 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized data will be shared through an online repository

Publications

Conrad MD, Asua V, Garg S, Giesbrecht D, Niare K, Smith S, Namuganga JF, Katairo T, Legac J, Crudale RM, Tumwebaze PK, Nsobya SL, Cooper RA, Kamya MR, Dorsey G, Bailey JA, Rosenthal PJ. Evolution of Partial Resistance to Artemisinins in Malaria Parasites in Uganda. N Engl J Med. 2023 Aug 24;389(8):722-732. doi: 10.1056/NEJMoa2211803.
PubMed 37611122
Tumwebaze PK, Conrad MD, Okitwi M, Orena S, Byaruhanga O, Katairo T, Legac J, Garg S, Giesbrecht D, Smith SR, Ceja FG, Nsobya SL, Bailey JA, Cooper RA, Rosenthal PJ. Decreased susceptibility of Plasmodium falciparum to both dihydroartemisinin and lumefantrine in northern Uganda. Nat Commun. 2022 Oct 26;13(1):6353. doi: 10.1038/s41467-022-33873-x.
PubMed 36289202

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy: a Longitudinal Study
ClinicalTrials.gov ID: NCT06347471
Acronym / sponsor ID: SPARTAN / SBS-2023-477
Conditions: Falciparum; Malaria
Keywords: Malaria Transmission, Artemisinin resistance, Gametocytes, Spread of resistance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Infectious Diseases Research Collaboration, UgandaUniversity, hospital or other
Collaborators: London School of Hygiene and Tropical Medicine, Radboud University Medical Center
Study start: 28 May 2024 (actual)
Primary completion: 22 Nov 2025 (actual)
Study completion: 22 Nov 2025 (actual)
First posted: 4 Apr 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
artemether-lumefantrine	Active comparator	Drug: Artemether-lumefantrineartemether-lumefantrine according to manufacturer instructions
dihydroartemisinin-piperaquine	Experimental	Drug: Dihydroartemisinin-Piperaquinedihydroartemisinin-piperaquine according to manufacturer instructions

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

age ≥2 years
blood smear positive for P. falciparum gametocytes
mono-infection with P. falciparum confirmed by positive blood smear;
parasitaemia of >100 P. falciparum asexual forms/µL;
ability to swallow oral medication;

Key exclusion criteria (5 listed)

presence of general danger signs;
mixed or mono-infection with another Plasmodium species detected by microscopy;
presence of severe malnutrition defined as a very low weight for height (below -3z scores of the median WHO growth standards), by visible severe wasting, or by the presence of nutritional oedema.
presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested

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
Artemether-lumefantrineAlso: CoartemParticipants in the Artemether-Lumefantrine arm will be treated with standard doses of AL (Coartem, Novartis). Tablets containing 20/80 mg artemether and 120/480 mg lumefantrine will be administered per manufacturer guidelines. All doses will be given under direct supervision with fatty food.	Drug	artemether-lumefantrine
Dihydroartemisinin-PiperaquineAlso: Eurartesim, DuocotecxinParticipants in the DHA-PPQ arm will be treated with standard doses of DHA-PPQ. Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine tablets (Eurartesim, Sigma Tau or Duocotecxin, Beijing Holley-Cotect Pharmaceutical Co) will be administered per manufacturer guidelines. All doses will be given under direct supervision on an empty stomach, as per manufacturer instructions.	Drug	dihydroartemisinin-piperaquine

Primary outcome

Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline.
Time frame: day 2 vs day 0 (AL arm) and day 7 vs day 0 (DP arm)
Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline (day 0, pre-treatment) to day 2 post treatment in the AL and day 7 post-treatment in the DHA-PPQ arm. Infectivity is assessed by mosquito membrane feeding assays; percent reduction is calculated separately for ΔPfK13 vs wild type infections.

12 secondary outcomes

Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline
Time frame: days 0, 2, 7
Mean oocyst intensity (in all/all infected mosquitoes)
Time frame: days 0, 2, 7
Male and female gametocyte sex ratio (proportion male)
Time frame: days 0, 1, 2, 3, 7, 14
Gametocyte circulation time
Time frame: days 0, 1, 2, 3, 7, 14
Gametocyte area under the curve
Time frame: days 0, 1, 2, 3, 7, 14
Asexual parasite prevalence
Time frame: Hours 0, 8, 16, Days 1, 2, 3, 7, 14
Asexual parasite density
Time frame: Hours 0, 8, 16, Days 1, 2, 3, 7, 14
Total parasite prevalence
Time frame: Hours 0, 8, 16, Days 1, 2, 3, 7, 14
Total parasite density
Time frame: Hours 0, 8, 16, Days 1, 2, 3, 7, 14
The density of ΔPfK13 vs wild type genotypes
Time frame: days 0, 1, 2, 3, 7, 14
The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment
Time frame: days 0, 2, 7
Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline after gametocyte enrichment
Time frame: days 0, 2, 7

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 6 Jul 2026.
Results publication: PubMed 37611122Conrad MD, Asua V, Garg S, Giesbrecht D, Niare K, Smith S, Namuganga JF, Katairo T, Legac J, Crudale RM, Tumwebaze PK, Nsobya SL, Cooper RA, Kamya MR, Dorsey G, Bailey JA, Rosenthal PJ. Evolution of Partial Resistance to Artemisinins in Malaria Parasites in Uganda. N Engl J Med. 2023 Aug 24;389(8):722-732. doi: 10.1056/NEJMoa2211803.
Results publication: PubMed 36289202Tumwebaze PK, Conrad MD, Okitwi M, Orena S, Byaruhanga O, Katairo T, Legac J, Garg S, Giesbrecht D, Smith SR, Ceja FG, Nsobya SL, Bailey JA, Cooper RA, Rosenthal PJ. Decreased susceptibility of Plasmodium falciparum to both dihydroartemisinin and lumefantrine in northern Uganda. Nat Commun. 2022 Oct 26;13(1):6353. doi: 10.1038/s41467-022-33873-x.
Individual participant dataSharing planned: Yes. Anonymized data will be shared through an online repository

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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.

Teun Bousema, PhD principal investigator

London School of Hygiene and Tropical Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Artemether-lumefantrine and Dihydroartemisinin-Piperaquine in people with Falciparum; Malaria, run by Infectious Diseases Research Collaboration, Uganda 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 8 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: finished, as of the sponsor's last update on 6 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 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.

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?

Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline. (time frame: day 2 vs day 0 (AL arm) and day 7 vs day 0 (DP arm)). 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 NCT06347471, 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 6 Jul 2026.