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

NCT03705624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 907

Last updated 2020-02-28

No results posted yet for this study

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

Interventions

OTHER

Enhanced Community Case Management (CCM)

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

OTHER

Monthly Screening and Treatment (MSAT)

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.

Sponsors & Collaborators

  • Centre national de recherche et de formation sur le paludisme

    collaborator OTHER_GOV

  • Radboud University Medical Center

    collaborator OTHER

  • Institute for Disease Modeling, Bellevue, US

    collaborator UNKNOWN

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Chris Drakeley, PhD · London School of Hygiene and Tropical Medicine, Faculty of Infectious and Tropical Diseases, London, United Kingdom

  • Alfred Tiono, PhD, MD · Centre national de recherche et de formation sur le paludisme

  • Teun Bousema, PhD · Radboud university medical centre, Nijmegen, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2020-02-14
Completion
2020-02-14

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705624 on ClinicalTrials.gov