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Malaria,FalciparumPhase 4NCT05980156

Comparing Chemoprevention Drugs for School-based Malaria Control

A Phase 4 study testing Dihydroartemisinin-Piperaquine, Chloroquine and Sulfadoxine pyrimethamine in people with Malaria,Falciparum and Anemia in Children, run by University of Maryland, Baltimore at 1 site in Malawi.

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

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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
646 participants
Where
1 siteMalawi
Study dates
13 Feb 2023to 28 Jul 2023
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

Who may be able to join

  • Students (enrolled in the primary intervention)
  • Previously enrolled in NCT05244954
  • 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 Younger children in participant households (enrolled in the Household Prevalence survey)
  • Slept in the household for most nights in the last month
  • Age 6-59 months
  • Parent/guardian available to provide written informed consent

Who cannot join

  • Students (enrolled in the primary intervention)
  • 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
Show all 11Show fewer
  • Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole
  • Epilepsy
  • Psoriasis Household members (enrolled in the Household Prevalence survey)
  • Household with more than one school-age child enrolled in the study
  • Current evidence of severe malaria or danger signs

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • Kamuzu University of Health Sciences

    Blantyre

Other trials in Malawi

About this study

Official title: Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission: Phase 2 Comparing Drug Regimens

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 chloroquine (CQ) (IPT-SPCQ). 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 in young children sleeping student's households to assess the impact on transmission.

Read the detailed description

Students attending a single primary school in Machinga District, Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study. The intervention will be conducted every 6-weeks during the two 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 10 years old and all males) or chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Being tested
Dihydroartemisinin-Piperaquine, Chloroquine, Sulfadoxine pyrimethamine
Keywords
malaria, school, chemoprevention, preventive treatment, education, cognitive function, adolescent, hemoglobin
Medical subject headings
Malaria, Falciparum, Malaria

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 10 years old and all males) or chloroquine alone (females 10 years old or older).

  • ChloroquineDrug

    Also called Aralen, Hydroxychloroquine, Lariago

    Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.

  • Sulfadoxine pyrimethamineDrug

    Also called SP

    Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).

Study groups in NCT05980156
Study groupRoleWhat they receive
Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)ExperimentalAll students are treated at each intervention. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).
Receives: Drug: Dihydroartemisinin-Piperaquine; Drug: Chloroquine
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)ExperimentalAll students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).
Receives: Drug: Chloroquine; Drug: Sulfadoxine pyrimethamine
ControlNo interventionStudents will not receive preventive treatment.

What is being measured

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

  1. Number of participants with P. falciparum infection

    detected by polymerase chain reaction (PCR, binary)

    Measured: 6-8 weeks after the last intervention

Secondary outcomes (9)

  1. Number of participants with anemia

    World Health Organization age-sex definitions (binary)

    Measured: 6-8 weeks after the last intervention

  2. Mean hemoglobin concentration

    g/dL (continuous)

    Measured: 6-8 weeks after the last intervention

  3. Total parasite density

    log transformed (continuous)

    Measured: 6-8 weeks after the last intervention

  4. Rate of clinical malaria

    cumulative incidence

    Measured: through study completions, approximately 6 months

  5. 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

  6. sustained attention

    code transmission test score (continuous)

    Measured: 6-8 weeks after the last intervention

  7. selective attention

    selective attention test score (continuous)

    Measured: 6-8 weeks after the last intervention

  8. Literacy skills

    onetest reading test score (continuous)

    Measured: 6-8 weeks after the last intervention

  9. Math skills

    onetest math score (continuous)

    Measured: 6-8 weeks after the last intervention

Timeline

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

  1. First posted7 Aug 2023
  2. Study start13 Feb 2023
  3. Primary completion28 Jul 2023
  4. Study completion28 Jul 2023

Resources

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 were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
646 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05980156
Sponsor's protocol ID
HP-00098250v3
Status last verified
Aug 2023
First submitted
28 Jul 2023
Last updated
7 Aug 2023
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

Publications

  • Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.

    PubMed 33767384

  • Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22.

    PubMed 33222799

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dihydroartemisinin-Piperaquine, Chloroquine and Sulfadoxine pyrimethamine in people with Malaria,Falciparum and Anemia in Children, run by University of Maryland, Baltimore 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?

The sponsor lists 8 inclusion and 11 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 7 Aug 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 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). 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 NCT05980156, 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 7 Aug 2023.

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Clinical Trial NCT05980156 | AzTrials