NCT04081051: Accelerator

Advancing Access to Diagnostic Innovation Essential for UHC and AMR Prevention

Completed NA Last updated 5 December 2023

What this trial tests

NA trial testing diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions) in Acute Febrile Illness in 17,294 participants. Completed in 30 September 2022.

Timeline

31 August 2020

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	Foundation for Innovative New Diagnostics, Switzerland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	17,294
Start date	31 August 2020
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	8 locations across Ghana, India, Burkina Faso, Uganda, Nepal

Drugs / interventions tested

• diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)

Conditions studied

• Acute Febrile Illness — all drugs for Acute Febrile Illness →

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Who can join

Adults 6 Months to 65, any sex, with Acute Febrile Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care (PoC) rapid diagnostic tests, and behaviour change interventions in cases of acute febrile illnesses in children, adolescents and adults presenting at out patient clinics in lower and middle income countries. The study is to be implemented in 2 phases- the first run from 2020 to 2021 and the 2nd phase from 2021 to 2022 to include COVID-19 PoCTs.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial.
   Salami O, Horgan P, Moore CE, Giri A, et al · · 2020 · cited 17× · PMID 33239106 · DOI 10.1186/s13063-020-04897-9
2. Impact of Point-of-Care Rapid Diagnostic Tests on Antibiotic Prescription Among Patients Aged <18 Years in Primary Healthcare Settings in 2 Peri-Urban Districts in Ghana: Randomized Controlled Trial Results.
   Adjei A, Kukula V, Narh CT, Odopey S, et al · · 2023 · cited 11× · PMID 37490745 · DOI 10.1093/cid/ciad328
3. A Randomized Trial to Assess the Impact of a Package of Diagnostic Tools and Diagnostic Algorithm on Antibiotic Prescriptions for the Management of Febrile Illnesses Among Children and Adolescents in Primary Health Facilities in Burkina Faso.
   Kiemde F, Valia D, Kabore B, Rouamba T, et al · · 2023 · cited 10× · PMID 37490742 · DOI 10.1093/cid/ciad331
4. Advancing Access to Diagnostic Tools Essential for Universal Health Coverage and Antimicrobial Resistance Prevention: An Overview of Trials in Sub-Saharan Africa.
   Olliaro P, Nkeramahame J, Salami O, Moore CE, et al · · 2023 · cited 5× · PMID 37490744 · DOI 10.1093/cid/ciad326
5. Cost-Effectiveness of Test-and-Treat Strategies to Reduce the Antibiotic Prescription Rate for Acute Febrile Illness in Primary Healthcare Clinics in Africa.
   van Dorst PWM, van der Pol S, Olliaro P, Dittrich S, et al · · 2024 · cited 3× · PMID 38796659 · DOI 10.1007/s40258-024-00889-x
6. Impact of a package of point-of-care diagnostic tests, a clinical diagnostic algorithm and adherence training on antibiotic prescriptions for the management of non-severe acute febrile illness in primary health facilities during the COVID-19 pandemic in Burkina Faso.
   Kiemde F, Nkeramahame J, Ibarz AB, Dittrich S, et al · · 2024 · cited 1× · PMID 39192209 · DOI 10.1186/s12879-024-09787-y
7. What Influences Patients' Adherence to Healthcare Worker Prescription in Primary Healthcare Facilities in Burkina Faso? A Qualitative Account of Barriers and Facilitators.
   Compaoré A, Nikièma J, Kiemdé F, Tinto H, et al · · 2023 · cited 1× · PMID 37490739 · DOI 10.1093/cid/ciad347
8. Viewpoint: Antimicrobial Resistance Diagnostics Use Accelerator: Qualitative Research on Adherence to Prescriptions.
   Compaoré A, Ekusai-Sebatta D, Kaawa-Mafigiri D, Kukula V, et al · · 2023 · cited 1× · PMID 37490738 · DOI 10.1093/cid/ciad323