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AzTrials

MalariaPhase 3NCT00852371

Intermittent Preventive Treatment of Malaria in Schoolchildren

A Phase 3 study testing sulfadoxine-pyrimethamine, amodiaquine + sulfadoxine-pyrimethamine and dihydroartemisinin-piperaquine in people with Malaria and Intermittent Preventive Treatment, run by London School of Hygiene and Tropical Medicine.

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 will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine +… Read more about this study

Who is it for?
Ages 8 to 13 years
Conditions the study is for
Malaria, Intermittent Preventive Treatment
What is being tested?
sulfadoxine-pyrimethamine, amodiaquine + sulfadoxine-pyrimethamine and dihydroartemisinin-piperaquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
780 participants
Where
No sites listed yet
Study dates
Feb 2008to Jun 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 8 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age ≥ 8 to < 14 years (boys), ≥ 8 to < 12 years (girls)
  • Student enrolled at participating school in classes 3-7
  • Provision of informed consent from parent or guardian
  • Provision of assent by student

Who cannot join

  • Known allergy or history of adverse reaction to study medications
  • Onset of menstruation (girls)
  • Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours
  • Evidence of severe malaria or danger signs
  • Haemoglobin < 7.0 gm/dL
  • Parasite density > 10,000/ul

About this study

Official title: IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda

This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.

Read the detailed description

The study will be carried out among children aged ≥ 8 to < 14 years (boys) and ≥ 8 to < 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending primary schools in Uganda. The accessible population includes the children attending the participating primary schools in classes 3-7 in Tororo district. Children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. Treatment efficacy outcomes will be assessed using revised WHO outcome classification criteria. Acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. The primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.

Being tested
sulfadoxine-pyrimethamine, amodiaquine + sulfadoxine-pyrimethamine, dihydroartemisinin-piperaquine, Placebo
Keywords
Malaria, Intermittent preventive treatment, Efficacy, Safety, Tolerability, Schoolchildren, Uganda
Medical subject headings
Malaria

What participants receive

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

  • sulfadoxine-pyrimethamineDrug

    Also called Fansidar, Roche

    25 mg/kg po once on day 0

  • amodiaquine + sulfadoxine-pyrimethamineDrug

    Also called Camoquin, Pfizer, Fansidar, Roche

    Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0

  • dihydroartemisinin-piperaquineDrug

    Also called Duocotexcin, Holley Cotec Pharmaceuticals

    2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)

  • PlaceboOther

    Also called No active ingredient

    dosed as for amodiaquine (10mg/kg po daily on days 1, 2)

Study groups in NCT00852371
Study groupRoleWhat they receive
Combination of Amodiaquine +sulfadoxine-pyrimethamineActive comparatorCombination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
Receives: Drug: amodiaquine + sulfadoxine-pyrimethamine
Dihydroartemisinin-piperaquineActive comparatorDihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
Receives: Drug: dihydroartemisinin-piperaquine
PlaceboPlacebo comparatorPlacebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
Receives: Other: Placebo
Sulfadoxine-pyrimethamine aloneActive comparatorsulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
Receives: Drug: sulfadoxine-pyrimethamine

What is being measured

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

  1. Risk of Parasitaemia (Unadjusted by Genotyping)

    Proportion of participants whose thick blood smears that are positive for asexual parasites

    Measured: after 42 days of follow-up

Secondary outcomes (7)

  1. Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment

    Proportion of participants whose thick blood smears that are positive with the same asexual parasites at baseline and on the day of failure at genotyping

    Measured: after 42 days of follow-up

  2. Risk of New Infection (Adjusted by Genotyping) in All Participants

    Proportion of participants whose thick blood smears that are positive for new asexual parasites on day of failure at genotyping

    Measured: after 42 days of follow-up

  3. Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment

    Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up

    Measured: Over 42 days of follow-up

  4. Mean Change in Haemoglobin

    Haemoglobin measured in g/dL; Mean change in haemoglobin calculated as the difference in mean haemoglobin (g/dL) on Day 42 - Day 0, in children treated with the different antimalarial regimens

    Measured: Between day 0 to day 42

  5. Risk of Serious Adverse Events

    Any untoward medical occurrence in a participant taking study medication after 14 and 42 days of follow up leading to death, disability, hospitalization or extended hospitalization

    Measured: over 42 days of follow-up

  6. Acceptability of IPT Regimens

    Perceived willingness to take study medication as routine preventive treatment

    Measured: on day 7

  7. Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment

    Proportion of children who were parasitaemia at enrollment, with subsequent fever and a positive thick blood smear for asexual parasites on the day of failure during follow-up

    Measured: after 42 days of follow-up

Timeline

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

  1. First posted27 Feb 2009 (estimated)
  2. Study startFeb 2008
  3. Primary completionJun 2008
  4. Study completionJun 2008

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
780 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00852371
Sponsor's protocol ID
ITCRVG49
Other IDs
LSHTM Ethics 5197
Status last verified
Mar 2024
First submitted
7 Feb 2008
Last updated
21 Mar 2024
Data monitoring committee
Yes

Publications

  • Nankabirwa J, Cundill B, Clarke S, Kabatereine N, Rosenthal PJ, Dorsey G, Brooker S, Staedke SG. Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren. PLoS One. 2010 Oct 19;5(10):e13438. doi: 10.1371/journal.pone.0013438.

    PubMed 20976051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sulfadoxine-pyrimethamine, amodiaquine + sulfadoxine-pyrimethamine and dihydroartemisinin-piperaquine in people with Malaria and Intermittent Preventive Treatment, run by London School of Hygiene and Tropical Medicine.

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 4 inclusion and 6 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Risk of Parasitaemia (Unadjusted by Genotyping) (time frame: after 42 days of follow-up). 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 NCT00852371, 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 21 Mar 2024.

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