Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04081051 |
Other study ID # |
AM 001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 31, 2020 |
Est. completion date |
September 30, 2022 |
Study information
Verified date |
November 2023 |
Source |
Foundation for Innovative New Diagnostics, Switzerland |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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