Clinical trial NCT03705624: P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1a)
Official title: P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1a)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: falciparum
gametocyte
elimination
anopheles
transmission
diagnostic
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Centre national de recherche et de formation sur le paludisme
name: Radboud University Medical Center
name: Institute for Disease Modeling, Bellevue, US
First posted: 2018-10-15
Enrollment: 907
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial
Primary purpose: DIAGNOSTIC

Brief summary: In the current randomized trial, the investigators will test the ability of two experimental approaches to malaria infection management to reduce malaria transmission potential. Compounds in Saponé, Burkina Faso, will be randomized to 1 of 3 study arms: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced community case management (CCM), comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus monthly screening and treatment (MSAT) using RDTs. The study will be conducted over approximately 18 months covering two high transmission seasons and the intervening dry season


Eligibility criteria: Inclusion Criteria:

1. Participants should be permanent residents of the compound
2. Participants should be willing to participate in repeated assessments of health and infection status and willing to donate a maximum of 37mL of blood (children \<10 years of age) or 52mL of blood (older individuals) during an 18-month period

Exclusion Criteria:

1. Any (chronic) illness that would affect with study participation
2. Pre-existing severe chronic health conditions
3. Current participation in malaria vaccine trials or participation in such trials in the last 2 years
4. History of intolerance to artemether-lumefantrine

Primary outcomes:
measure: Parasite prevalence and density by molecular detection at the end of study cross-sectional survey.
timeFrame: Month 18 (end of second transmission season; January-February 2020)
Secondary outcomes:
measure: Parasite prevalence and density by molecular detection at the end of year 1 cross-sectional survey.
timeFrame: Month 6 (end of first transmission season; January-February 2019)
measure: Parasite prevalence and density by molecular detection at the end of dry season cross-sectional survey.
timeFrame: Month 12 (prior to second transmission season; June 2019)
measure: Gametocyte prevalence and or density in P. falciparum infections at the end of study cross-sectional survey
timeFrame: Month 18 (end of second transmission season; January-February 2020)
measure: Gametocyte prevalence and or density in P. falciparum infections at the end of year 1 cross-sectional survey
timeFrame: Month 6 (end of first transmission season; January-February 2019)
measure: Gametocyte prevalence and or density in P. falciparum infections at the end of dry season cross-sectional survey
timeFrame: Month 12 (prior to second transmission season; June 2019)
measure: Gametocyte prevalence and or density in P. falciparum during all study visits
timeFrame: Throughout study, an average of 18 months
measure: The number of incident infections.
timeFrame: Throughout study, an average of 18 months
measure: Infectivity to mosquitoes of P. falciparum infections
timeFrame: Throughout study, an average of 18 months
Other outcomes:
measure: The detectability of infections by highly sensitive rapid diagnostic tests.
timeFrame: Throughout study, an average of 18 months
measure: The relationship between the proportion of infected mosquitoes and gametocyte density.
timeFrame: Throughout study, an average of 18 months.
measure: The impact of infection characteristics on the transmissibility of infections to mosquitoes
timeFrame: Throughout study, an average of 18 months.
measure: The impact of human host characteristics on the transmissibility of infections to mosquitoes
timeFrame: Throughout study, an average of 18 months
measure: Association between total parasite density and gametocyte density
timeFrame: Throughout study, an average of 18 months
measure: Malaria transmission potential based on measured gametocyte densities
timeFrame: Throughout study, an average of 18 months
measure: Number of acquired clones based on genotyping
timeFrame: Throughout study, an average of 18 months
measure: The duration of infections in the dry season
timeFrame: Month 6-12, between end of season survey January/February 2019 and end of dry season survey June 2019
measure: To quantify mosquito exposure in relation to incident infections
timeFrame: Throughout study, an average of 18 months
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Centre National de Recherche et de Formation sur le Paludisme
Study officials:
affiliation: London School of Hygiene and Tropical Medicine, Faculty of Infectious and Tropical Diseases, London, United Kingdom
name: Chris Drakeley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre national de recherche et de formation sur le paludisme
name: Alfred Tiono, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud university medical centre, Nijmegen, The Netherlands
name: Teun Bousema, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins KA, Ouedraogo A, Guelbeogo WM, Awandu SS, Stone W, Soulama I, Ouattara MS, Nombre A, Diarra A, Bradley J, Selvaraj P, Gerardin J, Drakeley C, Bousema T, Tiono A. Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial. BMJ Open. 2019 Sep 13;9(9):e030598. doi: 10.1136/bmjopen-2019-030598.