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OpenTrials
Completed

NCT Number: NCT01231880

School Based Malaria Control in Ugandan Schoolchildren

The investigators hypothesize that schoolchildren treated with IPT using DP over one year of follow-up will have a different risk of clinical malaria compared to those treated with placebo.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mulanda Sub-district

Tororo, Uganda, 256

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 6 - 14 years
  • Pupils enrolled at participating school
  • Willingness of the parent/guardian to provide consent
  • Provision of assent by pupil (those above 8 years)

Exclusion criteria

  • Known allergy or history of adverse reaction to study medications
  • Intention of changing of schools during the follow-up period
  • History (obtained from the parent/guardian) of any known serious chronic disease requiring frequent medical care

Treatment and study plan

Four monthly IPT with dihydroartemisinin Piperaquine (DP)

Drug

Given every 4 months (once a school term)

Other names: Duocortexin

Monthly IPT using DP

Drug

Given every month

Other names: Duocortexin

Placebo given every month

Drug

No active ingredient

Other names: Placebo

Primary outcomes

  1. Risk of Clinical Malaria

    Time frame: 1 year

    Fever(temperature greater or equal to 37.5 degrees centigrade or history of fever in past 24 hours) in presence of parasitemia.

  2. Cognitive function tests

    Time frame: 1 year

    Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)

Secondary outcomes

  1. Risk of parasitemia

    Time frame: 1 year

    presence of asexual parasites on blood smear

  2. Risk of hospital admissions

    Time frame: 1 year

    Admission of any cause

  3. Risk of adverse events

    Time frame: 1 year

    Any untoward medical occurrence in a participant taking study medication

  4. School performance

    Time frame: 1 year

    Average position in class as reported in the end of the year school report

  5. Prevalence of anemia

    Time frame: 1 year

    Proportion of hemoglobin measurements < 10 g/dL.

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study title

School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children

Acronym: SBMC

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2010
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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