Malaria Clinical Trial
Official title:
Attractive Targeted Sugar Bait Phase III Trial in Zambia
Verified date | November 2023 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The trial will evaluate the efficacy of ATSB deployment plus universal coverage of a WHO core vector control (VC) interventions over two transmission seasons on a minimum 30% reduction in cohort clinical disease incidence, confirmed case incidence, and parasite prevalence, as compared with VC alone. Measurement of entomological outcomes, assessment of acceptability and barriers to uptake and consistent use of ATSB, safety and adverse event monitoring and estimation of the cost and cost-effectiveness of ATSB will also occur.
Status | Active, not recruiting |
Enrollment | 3480 |
Est. completion date | December 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 15 Years |
Eligibility | Inclusion Criteria: - Household resident - =12 months and <15 years of age at the time of enrollment - If age 12 months - 6 years of age, parent or guardian provides consent for child's participant - If age 7-14 years, parent or guardian provides consent for child's participant and child provides assent for participation Exclusion Criteria: - Residence within the buffer zone - Age <12 months or =15 years of age at the time of cohort enrollment - Household contained a participant in the first cohort (for participation in the second cohort) - Pregnant at the time of cohort enrollment. Pregnant adolescents are excluded because they are eligible for protection from infection through pregnancy standard of care - intermittent preventative therapy during pregnancy (IPTp), and to avoid undue discomfort with repeated blood sampling. - Pregnancy at any time during the cohort study. Pregnancy will be identified in adolescents at enrollment and follow-up visits through a single question regarding pregnancy status during each cohort visit. When an adolescent indicates that she is pregnant or is unsure of her pregnancy status, she will no longer be followed for ongoing blood testing for the reasons noted above and will be censored in the analysis. - Does not provide consent/assent required according to age to participate in the study |
Country | Name | City | State |
---|---|---|---|
Zambia | Kaoma District | Kaoma | Western Province |
Lead Sponsor | Collaborator |
---|---|
PATH | Macha Research Trust, Zambia, Ministry of Health, Zambia, Tulane University |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical malaria case incidence | Clinical malaria case incidence measured by cohort and defined as fever (history of fever in the past 48 hours or an axillary temperature =37.5o C. at follow-up visit) plus a positive RDT in children =12 months and <15 years in age. | Seasonal (6 months) | |
Secondary | Time to first infection | Time to first infection measured among the cohort and defined as the time to first PCR infection among participants aged =12 months and <15 years of age. | Seasonal (6 months) | |
Secondary | Prevalence, detected by PCR | Prevalence of malaria infection measured by the cross-sectional household survey among participants aged =6 and older, detected by PCR. | 6 weeks | |
Secondary | Prevalence, detected by RDT | Prevalence of malaria infection measured by the cross-sectional household survey among participants aged =6 and older, detected by RDT (patent infection). | 6 weeks | |
Secondary | Incidence rate of passively reported clinical malaria | Incidence rate of clinical malaria among participants of all ages, defined as the number of malaria confirmed cases (by RDT or microscopy) per 1,000 population per year, using routine data from health facilities linked to study clusters (i.e. by name of village of residence) and cluster population sizes for the denominator. | Seasonal (6 months) |
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