School Based Malaria Control in Ugandan Schoolchildren

Malaria Clinical Trial

— SBMC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231880
• Other study ID #: MCDC-SBMC
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2010
• Last updated: May 22, 2013
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Uganda National Council of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Four monthly IPT with dihydroartemisinin Piperaquine (DP)
Given every 4 months (once a school term)
• Monthly IPT using DP
Given every month
• Placebo given every month
No active ingredient

Locations

Country	Name	City	State
Uganda	Mulanda Sub-district	Tororo

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of Clinical Malaria	Fever(temperature greater or equal to 37.5 degrees centigrade or history of fever in past 24 hours) in presence of parasitemia.	1 year	Yes
Primary	Cognitive function tests	Mean score in the cognitive function tests (Raven's Matrices test and Code transmission test)	1 year	No
Secondary	Risk of parasitemia	presence of asexual parasites on blood smear	1 year	Yes
Secondary	Risk of hospital admissions	Admission of any cause	1 year	Yes
Secondary	Risk of adverse events	Any untoward medical occurrence in a participant taking study medication	1 year	Yes
Secondary	School performance	Average position in class as reported in the end of the year school report	1 year	No
Secondary	Prevalence of anemia	Proportion of hemoglobin measurements < 10 g/dL.	1 year	Yes