Advancing Access to Diagnostic Innovation Essential for UHC and AMR Prevention
Condition: Acute Febrile Illness
Study type: Interventional

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.
    

Detailed description: 
      Background and rationale. 'Just-in-case' antibiotic prescribing practices is one of the
      causes of inadequate management of 'acute febrile illnesses' and AMR in Low- and
      Middle-income Countries (LMICs). At the same time, some people who would require antibiotic
      treatment do not get it. An improvement in case management and prescription practice might
      lead to a decrease in morbidity and mortality. Success will mean making significant steps
      toward achieving the dual goal of improving UHC and tackling AMR.

      The PICO question addressed is: in children/ adolescents and adults (Population) presenting
      to outpatient clinics / peripheral health centres in LMICs with acute febrile
      illness/Respiratory Tract Infection can a combination of available PoC rapid diagnostic
      tests, diagnostic aids/algorithms, clinic process flow and, training and communication
      (Intervention) improve management of acute febrile illnesses and better target the use of
      antibiotics / reduce unnecessary antibiotic prescriptions (Outcomes) compared to current
      practice (Control)?

      Primary objective(s).

      To evaluate the impact of a package of interventions (point of care [PoC] tests, clinical
      algorithm, clinic process flow, training and communication tools) on clinical outcomes and
      antibiotic prescriptions, with standard-of-care practices, in children and adolescents
      presenting with acute febrile illnesses (defined as fever with no focus or Respiratory Tract
      Infection lasting for no more than 7 days), at outpatient clinics.

      Secondary objective(s)

        1. To improve the management of acute febrile illness

        2. To promote rational and targeted use of antibiotics for acute febrile illness

        3. To determine the aetiology of fever in patients presenting to outpatient facilities
           using available PoC diagnostic tests

        4. To study the safety and feasibility of a package of interventions compared to current
           practice of care

        5. To assess the effectiveness of training and communication tools to adherence to the
           prescribed treatment

      Primary endpoints

        1. Proportion of outpatient cases of acute febrile illness with favourable outcome (defined
           as being alive and asymptomatic).

        2. antibiotic prescriptions rates for acute febrile illness in the clinic Secondary
           endpoints (outcomes) 1. Duration of time spent in the clinic

      2. Proportion of patients treated for specific bacterial infection 3. Proportion of patients
      with disease specific diagnosis identified by PoC tests 4. Frequency of serious adverse event
      (SAE) within 7 days of recruitment 5. Frequency of unscheduled (unplanned) visit within 7
      days of recruitment 6. Training and communication package uptake 7. Proportion of patients
      prescribed antibiotic at clinic who reported adherence to prescription on day 7 8. Proportion
      of patients who were not prescribed antibiotics at clinic who received antibiotics elsewhere
      between day 0 and day 7 9. Behaviour Change Intervention Recommendations

      Trial design: A multi-centre, open label, two arm, randomized-controlled trial

      Trial sites: This study will be conducted in outpatient departments and primary care clinics
      in Burkina Faso, Ghana, India, Nepal and Uganda.

      Trial population: The study population will consist of children, adolescents and adults
      presenting to the health care facility, or provider, with acute fever or history of fever

      Sample Size: 19,922
    

Intervention name(s): diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)
Intervention type(s): Other
Intervention description(s): Diagnostic algorithm utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change intervention for healthcare workers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic