Advancing Access to Diagnostic Innovation Essential for UHC and AMR Prevention

NCT04081051 | Completed DMC

• 1 other identifier: AM 001
• Study Type: interventional
• Target: 17,294
• Locations: 5 countries
• Sites: 8

Brief Summary

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.

Conditions

Acute Febrile Illness

Outcome Measures

Primary Outcomes (2)

• Proportion of acute febrile cases with favorable clinical outcomes at day 7

  Favorable defined as being alive and asymptomatic.

  Day 7

• Antibiotic prescription rates in acute fever cases

  Proportion of antibiotic prescriptions for acute febrile illness in the clinic

  Day 0

Secondary Outcomes (4)

• Proportion of participants with acute fever Diagnoses identified by point of care tests.

  Day 0

• Adverse events

  Day 7

• Time spent in the clinic

  Day 0

• Proportion of study participants who adhered to antibiotic prescriptions

  Day 7

Study Arms (2)

Intervention

EXPERIMENTAL

Diagnostic algorithm( paper and electronic) utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change training for healthcare workers

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

control

NO INTERVENTION

Standard of care practices for acute febrile illness

Interventions

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

Diagnostic algorithm utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change intervention for healthcare workers

Intervention

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with fever with no focus/RTI:
• Children (6 months to \<12 years) and adolescents (12 years to less than 18 years old) of both sexes .
• Presenting with an acute febrile illness defined as temperature of \>37.5°C or history of fever within the last 7 days with no focus or suspected RTI.
• Parent/guardian providing written informed consent for their children if less than 18 years of age.
• Obtain assent for adolescent between 12 and less than 18 years old
• Willing to provide blood and other samples and adhere to study procedures explained in the consent forms following the protocol.
• Available and willing to return for follow-up visit at the health facility on day 7 (+/- 2 days).

You may not qualify if:

• o Children and adolescents from 6 months to less than 18 years old presenting with chronic febrile illness (fever lasting more than 7 days).
• Patients with acute febrile illness outside the allowed age range for the site.
• Severely ill patients requiring hospital admission or referral as assessed by the study clinicians.
• Anyone refusing consent to the study or not able to attend the health centre for follow-up (adults, the children of parents/guardians, or adolescents who refuse or are missed when asking for consent).

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• University of Oxford: collaborator
• Indian Council of Medical Research: collaborator
• WHO, Special Programme for Research and Training in Tropical Diseases (TDR): collaborator

Study Sites (8)

IRSS-DRCO/Clinical Research Unit of Nanoro (CRUN)

Nanoro, BP 218, Burkina Faso

Location

Shai-Osudoku District Hospital

Accra, Dodowa, Ghana

Location

Jan Swathya Sahyog

Ganiyari, Chhattisgarh, 495112, India

Location

National Institute of Cholera & Enteric Diseases

Beliaghata, Kolkata, 700010, India

Location

R D Gardi Medical College

Ujjain, Madhya Pradesh, 456006, India

Location

Post Graduate Insitute Medical Education and Research

Chandigarh, 160012, India

Location

Patan Academy of Health Sciences

Lalitpur, Lagankhel, 44700, Nepal

Location

Infectious Disease research collaboration

Kampala, Uganda

Location

Related Publications (5)

• Kiemde F, Nkeramahame J, Ibarz AB, Dittrich S, Olliaro P, Valia D, Rouamba T, Kabore B, Kone AN, Sawadogo S, Bere AW, Some DY, Some AM, Compaore A, Horgan P, Weber S, Keller T, Tinto H. 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. BMC Infect Dis. 2024 Aug 27;24(1):870. doi: 10.1186/s12879-024-09787-y.

  PMID: 39192209 DERIVED

• Adjei A, Kukula V, Narh CT, Odopey S, Arthur E, Odonkor G, Mensah MM, Olliaro P, Horgan P, Dittrich S, Moore CE, Salami O, Awini E, Nkeramahame J, Williams J, Baiden R. 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. Clin Infect Dis. 2023 Jul 25;77(Suppl 2):S145-S155. doi: 10.1093/cid/ciad328.

  PMID: 37490745 DERIVED

• Kiemde F, Valia D, Kabore B, Rouamba T, Kone AN, Sawadogo S, Compaore A, Salami O, Horgan P, Moore CE, Dittrich S, Nkeramahame J, Olliaro P, Tinto H. 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. Clin Infect Dis. 2023 Jul 25;77(Suppl 2):S134-S144. doi: 10.1093/cid/ciad331.

  PMID: 37490742 DERIVED

• Compaore A, Ekusai-Sebatta D, Kaawa-Mafigiri D, Kukula V, Odopey S, Kapisi J, Hopkins H, Kiemde F, Tinto H, Baiden R, Olliaro P, Nkeramahame J, Dittrich S, Horgan P; ADIP study group. Viewpoint: Antimicrobial Resistance Diagnostics Use Accelerator: Qualitative Research on Adherence to Prescriptions. Clin Infect Dis. 2023 Jul 25;77(Suppl 2):S206-S210. doi: 10.1093/cid/ciad323.

  PMID: 37490738 DERIVED

• Salami O, Horgan P, Moore CE, Giri A, Sserwanga A, Pathak A, Basnyat B, Kiemde F, Smithuis F, Kitutu F, Phutke G, Tinto H, Hopkins H, Kapisi J, Swe MMM, Taneja N, Baiden R, Dutta S, Compaore A, Kaawa-Mafigiri D, Hussein R, Shakya SU, Kukula V, Ongarello S, Tomar A, Chadha SS, Walia K, Kelly-Cirino C, Olliaro P. 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. Trials. 2020 Nov 25;21(1):974. doi: 10.1186/s13063-020-04897-9.

  PMID: 33239106 DERIVED

Study Officials

• Piero Olliaro, MD

  Foundation for Innovative New Diagnostics (FIND)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 6, 2019
• Study Start: August 31, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); GH (1); BU (1); IN (4); NE (1)