Clinical trial NCT05567016: CHILD (Child Health and Infection With Low Density) Malaria
Official title: Child Health and Infection With Low Density (CHILD) Malaria, a Randomized Controlled Trial to Assess the Long-term Health and Socioeconomic Impact of Interventions Targeting Low-density Malaria Infection (LMI) Among Children in Tanzania
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malaria,Falciparum
Malaria
Keywords: malaria
child health
chronic infection
subclinical infection
patent infection
subpatent infection
active case detection
passive case detection
fever case management
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Ifakara Health Institute
name: Swiss Tropical & Public Health Institute
name: Stanford University
name: Chan Zuckerberg Biohub
First posted: 2022-10-05
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual randomized controlled trial
Primary purpose: PREVENTION

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of all-cause sick visits
timeFrame: 24 months from enrollment
Secondary outcomes:
measure: Prevalence of anemia
timeFrame: 24 months from enrollment
measure: Prevalence of underweight status
timeFrame: 24 months from enrollment
measure: Prevalence of stunting
timeFrame: 24 months from enrollment
measure: Prevalence of wasting
timeFrame: 24 months from enrollment
measure: Prevalence of malnutrition
timeFrame: 24 months from enrollment
measure: Prevalence of vomiting following administration of study drugs
timeFrame: 24 months from enrollment
measure: All-cause fever episodes
timeFrame: 24 months from enrollment
measure: Incidence of clinical symptoms
timeFrame: 24 months from enrollment
measure: Incidence of clinical malaria
timeFrame: 24 months from enrollment
measure: Proportion of fever episodes with clinical failure
timeFrame: 24 months from enrollment
measure: Prevalence of parasitemia
timeFrame: 24 months from enrollment
measure: Incidence in antibiotics prescribed
timeFrame: 24 months from enrollment
measure: Cognitive ability among children 0-3.4 years of age on the Global Scales of Early Development (GSED)
timeFrame: 24 months from enrollment
measure: Cognitive ability among children 3.5-5 years of age on the International Development and Early Learning Assessment (IDELA)
timeFrame: 24 months from enrollment
measure: Cognitive ability among children 6-12 years of age on the East Africa Neurodevelopment Assessment Tool
timeFrame: 24 months from enrollment
measure: Sustained attention among children 5-8 years of age on the Pencil Tapping Test
timeFrame: 24 months from enrollment
measure: Sustained attention among children 9-12 years of age on the Code Transmission Test, a local adaptation of the Test of Everyday Attention for Children(TEA-Ch)
timeFrame: 24 months from enrollment
measure: Incidence of school absenteeism
timeFrame: 24 months from enrollment
measure: School performance
timeFrame: 24 months from enrollment
measure: Socioeconomic costs to participant
timeFrame: 24 months from enrollment
measure: Socioeconomic costs to family
timeFrame: 24 months from enrollment
measure: Socioeconomic costs to health system
timeFrame: 24 months from enrollment
measure: Cost effectiveness
timeFrame: 24 months from enrollment
measure: Prevalence of systemic inflammation
timeFrame: 24 months from enrollment
measure: Proportion with antimalarial antibodies against P.falciparum
timeFrame: 24 months from enrollment
measure: Proportion with biomarkers of inflammation
timeFrame: 24 months from enrollment
measure: Proportion with general antibody responses to vaccines
timeFrame: 24 months from enrollment
measure: Proportion with general antibody responses to common pathogens
timeFrame: 24 months from enrollment
measure: Incidence of adverse events (AEs)
timeFrame: 24 months from enrollment
measure: Incidence of wasting
timeFrame: 24 months from enrollment
measure: Incidence of stunting
timeFrame: 24 months from enrollment
Other outcomes:
Locations:
city: Bagamoyo
country: Tanzania
facility: Kiwangwa and Fukayosi clinics
Study officials:
affiliation: University of California, San Francisco
name: Michelle Hsiang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Institute
name: Ally Olotu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: