P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1a)

NCT03705624 | Completed

• 1 other identifier: INDIE-1a
• Study Type: interventional
• Target: 907
• Locations: 1 country
• Sites: 1

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

Conditions

Malaria

Keywords

falciparum; gametocyte; elimination; anopheles; transmission; diagnostic

Outcome Measures

Primary Outcomes (1)

• Parasite prevalence and density by molecular detection at the end of study cross-sectional survey.

  The primary outcome measure is parasite prevalence in the cross-sectional survey conducted at the end of the transmission season of year 2. If CCM and MSAT result in the early detection of infections, parasite prevalence at the end of the study will be lower in these arms compared to the control arm.

  Month 18 (end of second transmission season; January-February 2020)

Secondary Outcomes (8)

• Parasite prevalence and density by molecular detection at the end of year 1 cross-sectional survey.

  Month 6 (end of first transmission season; January-February 2019)

• Parasite prevalence and density by molecular detection at the end of dry season cross-sectional survey.

  Month 12 (prior to second transmission season; June 2019)

• Gametocyte prevalence and or density in P. falciparum infections at the end of study cross-sectional survey

  Month 18 (end of second transmission season; January-February 2020)

• Gametocyte prevalence and or density in P. falciparum infections at the end of year 1 cross-sectional survey

  Month 6 (end of first transmission season; January-February 2019)

• Gametocyte prevalence and or density in P. falciparum infections at the end of dry season cross-sectional survey

  Month 12 (prior to second transmission season; June 2019)

Other Outcomes (9)

• The detectability of infections by highly sensitive rapid diagnostic tests.

  Throughout study, an average of 18 months

• The relationship between the proportion of infected mosquitoes and gametocyte density.

  Throughout study, an average of 18 months.

• The impact of infection characteristics on the transmissibility of infections to mosquitoes

  Throughout study, an average of 18 months.

Study Arms (3)

Standard of Care

NO INTERVENTION

Standard of care with passively monitored malaria incidence at health centers that receive appropriate diagnostic and clinical supplies and Seasonal Malaria Chemoprevention (SMC) for children less than 5 years of age

CCM

EXPERIMENTAL

Standard of care supplemented with enhanced Community Case Management for malaria (CCM) involving weekly active screening for fever using a research-grade thermometer by a trained health worker. A measured temperature ≥37.5°C or reported fever in the last 24 hours will prompt screening with a conventional rapid diagnostic test (RDT). RDT positive individuals will be treated with artemether-lumefantrine (AL) according to national guidelines

Other: Enhanced Community Case Management (CCM)

CCM+MSAT

EXPERIMENTAL

Standard of Care supplemented with CCM and Monthly Screening and Treatment (MSAT) regardless of symptoms with a conventional RDT. Screening will be performed by research staff with 25-35 days between screening rounds; RDT positive individuals will be treated with AL according to national guidelines.

Other: Enhanced Community Case Management (CCM); Other: Monthly Screening and Treatment (MSAT)

Interventions

Enhanced Community Case Management (CCM) OTHER

Enhanced Community Case Management for malaria (CCM) involving weekly active screening for fever using a research-grade thermometer by a trained health worker. A measured temperature ≥37.5°C or reported fever in the last 24 hours will prompt screening with a conventional rapid diagnostic test (RDT). RDT positive individuals will be treated with AL according to national guidelines

CCM; CCM+MSAT

Monthly Screening and Treatment (MSAT) OTHER

Monthly Screening and Treatment (MSAT) regardless of symptoms with a conventional RDT. Screening will be performed by research staff with 25-35 days between screening rounds; RDT positive individuals will be treated with AL according to national guidelines.

CCM+MSAT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants should be permanent residents of the compound
• 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

You may not qualify if:

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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Centre national de recherche et de formation sur le paludisme: collaborator
• Radboud University Medical Center: collaborator
• Institute for Disease Modeling, Bellevue, US: collaborator

Study Sites (1)

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, Burkina Faso

Location

Related Publications (2)

• Collins KA, Ouedraogo A, Guelbeogo WM, Soulama I, Ouattara MS, Sombie S, Ouedraogo N, Coulibaly AS, Nombre A, Lanke K, Ramjith J, Awandu SS, Serme SS, Henry N, Stone W, Ouedraogo IN, Diarra A, Holden TM, Sirima SB, Bradley J, Soremekun S, Selvaraj P, Gerardin J, Drakeley C, Bousema T, Tiono AB. Effect of weekly fever-screening and treatment and monthly RDT testing and treatment on the infectious reservoir of malaria parasites in Burkina Faso: a cluster-randomised trial. Lancet Microbe. 2024 Sep;5(9):100891. doi: 10.1016/S2666-5247(24)00114-9. Epub 2024 Jul 25.

  PMID: 39068937 DERIVED

• 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.

  PMID: 31519680 DERIVED

MeSH Terms

Conditions

Malaria; Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Drakeley, PhD

  London School of Hygiene and Tropical Medicine, Faculty of Infectious and Tropical Diseases, London, United Kingdom

  PRINCIPAL INVESTIGATOR

• Alfred Tiono, PhD, MD

  Centre national de recherche et de formation sur le paludisme

  PRINCIPAL INVESTIGATOR

• Teun Bousema, PhD

  Radboud university medical centre, Nijmegen, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: October 15, 2018
• Study Start: August 6, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: February 28, 2020

Record last verified: 2018-08

Locations

BU (1)