Intermittent Preventive Treatment of Malaria in School-age Children to Decrease Community Transmission (CRITICal)

May 5, 2026 updated by: University of California, San Francisco

Cluster Randomized Trial of Intermittent Preventive Treatment of Malaria in School-age Children to Improve the Health of Students and Decrease Community Transmission

The CRITICal study aims to estimate the effectiveness of intermittent preventive treatment in school children (IPTsc) with dihydroartemisinin-piperaquine (DP) for reducing community level malaria burden. Given that school-aged children are the primary drivers of transmission, the study hypothesis is that IPTsc will reduce this infectious reservoir and thus the burden of malaria in persons of all ages in surrounding communities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The CRITICal study is an open label, phase IV, cluster-randomized trial to evaluate the effectiveness of IPTsc with DP administered approximately every 2 months to children attending primary school. Clusters are geographically defined target areas surrounding government-run health facilities previously established and referred to as Malaria Reference Centers (MRCs). A total of 24 clusters (MRCs) will be included in the study. These clusters were selected based on participation in an on-going sentinel site malaria surveillance network in areas with moderate-high malaria transmission intensity. Clusters will be randomized in a 1:1 ratio such that all primary schools serving the populations of each target area will either receive IPTsc or not receive IPTsc. The intervention will be delivered for 2 years and evaluations will continue for 1 additional year after the intervention is stopped. The primary outcome of the study will be malaria incidence within the population of the target areas. Secondary outcomes will include the the prevalence of parasitemia and molecular markers of DP resistance at the community level; the prevalence of parasitemia, anemia, and school attendance among children attending primary school; and estimates of the cost-effectiveness of IPTsc.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Child currently attending the participating school.
  • Agreement of parent/guardian to provide informed consent.
  • Agreement of children aged 8-17 years to provide assent.

Exclusion Criteria:

  • Missing school on three consecutive days of the school survey.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IPTsc
DP will be administered approximately every 2 months for two years to all eligible children enrolled in primary schools serving the target areas from clusters randomized to the interventional arm.
Drug: dihydroartemisinin-piperaquine
D-Artepp, is manufactured by Guilin Pharmaceutical Co Ltd, and is prequalified by the WHO and approved for use in Uganda by the National Drug Authority. Standard treatment doses of DP (once a day x 3 days) will be administered using weight-based guidelines targeting a total dose of 6.4 mg/kg dihydroartemisinin and 51.2 mg/kg of piperaquine as per manufacturer's instructions.
Other Names:
  • D-Artepp
No Intervention: No IPTsc
No IPTsc (standard of care)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area during the period the intervention is implemented
Time Frame: 24 months after intervention implemented
malaria incidence: the number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area, per unit time, divided by the total population of the target area in patients of all ages over the 24-month intervention period
24 months after intervention implemented

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of cases of laboratory-confirmed malaria diagnosed among patients residing in the target area after the intervention is competed
Time Frame: 12 months after intervention is completed
malaria incidence: the number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area, per unit time, divided by the total population of the target area in patients of all ages 12 months after intervention is completed
12 months after intervention is completed
Parasite prevalence among community residents 12 months after the intervention is implemented
Time Frame: 12 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
12 months after the intervention is implemented
Parasite prevalence among community residents 24 months after the intervention is implemented
Time Frame: 24 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
24 months after the intervention is implemented
Parasite prevalence among community residents 12 months after the intervention is completed
Time Frame: 12 months after the intervention is completed
Proportion of blood smears positive for parasites by microscopy at the time of community cross-sectional surveys
12 months after the intervention is completed
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is implemented
Time Frame: 12 months after the intervention is implemented
Proportion of parasite positive samples with molecular markers of DP resistance detected
12 months after the intervention is implemented
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 24 months after the intervention is implemented
Time Frame: 24 months after the intervention is implemented
Proportion of parasite positive samples with molecular markers of DP resistance detected
24 months after the intervention is implemented
Prevalence of molecular markers of DP resistance from parasite positive samples from community surveys 12 months after the intervention is completed
Time Frame: 12 months after the intervention is completed
Proportion of parasite positive samples with molecular markers of DP resistance detected
12 months after the intervention is completed
Parasite prevalence among schoolchildren 12 months after the intervention is implemented
Time Frame: 12 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
12 months after the intervention is implemented
Parasite prevalence among schoolchildren 24 months after the intervention is implemented
Time Frame: 24 months after the intervention is implemented
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
24 months after the intervention is implemented
Parasite prevalence among schoolchildren 12 months after the intervention is completed
Time Frame: 12 months after the intervention is completed
Proportion of blood smears positive for parasites by microscopy at the time of school surveys
12 months after the intervention is completed
Anemia prevalence among schoolchildren 12 months after the intervention is implemented
Time Frame: 12 months after the intervention is implemented

Proportion of children with anemia at the time of school surveys

Anemia defined based on WHO criteria as:

  1. hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
  2. hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
  3. hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
12 months after the intervention is implemented
Anemia prevalence among schoolchildren 24 months after the intervention is implemented
Time Frame: 24 months after the intervention is implemented

Proportion of children with anemia at the time of school surveys

Anemia defined based on WHO criteria as:

  1. hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
  2. hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
  3. hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
24 months after the intervention is implemented
Anemia prevalence among schoolchildren 12 months after the intervention is completed
Time Frame: 12 months after the intervention is completed

Proportion of children with anemia at the time of school surveys

Anemia defined based on WHO criteria as:

  1. hemoglobin less than 11.5g/dl in children 5 - 11 years of age;
  2. hemoglobin less than 12.0g/dl in children 12 - 14 years of age and non-pregnant girls 15 years and above; and
  3. hemoglobin less than 13.0g/dl in boys 15 years and above) 12 and 24 months after the intervention is implemented and school attendance (defined as the number of days attending school / number of days school in session) over the 24-month intervention period
12 months after the intervention is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)
Ministry of Health, Uganda
Infectious Diseases Research Collaboration, Uganda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Grant Dorsey, MD, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRITICAL
  • U01AI186861 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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