CHILD (Child Health and Infection With Low Density) Malaria

University of California San Francisco (UCSF)

Status: Completed

Conditions: Malaria,Falciparum; Malaria

Treatments: Other: Active case detection using molecular testing (ACDm); Other: Passive case detection using molecular testing (PCDm); Other: Control (standard of care)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05567016

U01AI155315 (U.S. NIH Grant/Contract)

DMID protocol 21-0046

Details and patient eligibility

About

This trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (LMI) among children in Tanzania

Full description

This is a 3-arm open-label randomized control trial of 600 children aged 6 months to 10 years in Tanzania, where transmission is low and a high proportion of infections are low-density. Standard of care based on passive case detection (PCD) using rapid diagnostic test (control arm) will be compared to two different approaches to detect and treat P. falciparum LMI: active case detection using molecular testing (ACDm) and PCD using molecular testing (PCDm). Aims are:

1. To assess the impact of standard PCD plus ACDm vs standard PCD on long-term child health
2. To assess the impact of PCDm vs standard PCD on long-term child health
3. To evaluate the cost-effectiveness of ACDm and PCDm

Enrollment: 600 patients

Sex: All

Ages: 6 months to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 6 months to 10 years of age of age at enrollment
2. Primary residence in the study area during the study period
3. Agree to come to study clinic for any illness
4. Agree to avoid medications outside the study, even herbal medication

Exclusion criteria

1. Another child from household already randomly selected for recruitment
2. Not able or does not provide informed consent
3. Need for emergency intervention
4. Known history of chronic illness requiring regular specialty care including diabetes mellitus, cancer, or Stage 3 or 4 HIV/AIDS
5. Contraindications to artemether-lumefantrine (AL) including history of allergic reaction, weight under 5 kg
6. Participation in another active/ongoing intervention trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Active Case Detection using molecular testing (ACDm)

Experimental group

Description:

Per standard of care, children will receive passive case detection (PCD) using rapid diagnostic test (RDT) if they present with fever. Children will receive malaria active case detection (ACD) using RDT and qPCR (quantitative polymerase chain reaction) three times yearly with treatment using artemether-lumefantrine (AL) if RDT or qPCR positive.

Treatment:

Other: Active case detection using molecular testing (ACDm)

Passive Case Detection using molecular testing (PCDm)

Experimental group

Description:

Children who present with fever will receive PCD using RDT and qPCR with treatment using AL if RDT or qPCR positive. Per standard of care, children will not receive malaria ACD.

Treatment:

Other: Passive case detection using molecular testing (PCDm)

Standard passive case detection (PCD)

Active Comparator group

Description:

Per standard of care, children will receive PCD using RDT. Per standard of care, children will not receive malaria ACD.

Treatment:

Other: Control (standard of care)