Background

A ‘just-in-case’ antibiotic prescribing practice is one of the causes of antimicrobial resistance (AMR) and inadequate management of acute febrile illnesses, resulting in increased morbidity and mortality. At the same time, many who would require antibiotic treatment do not get it.

An adaptation in current practice needs to occur to improve case management in LMICs. Success will mean making significant steps toward achieving the dual goal of tackling AMR and providing universal health coverage (UHC).

COVID-19 is now a part of the reality of acute fever management globally and in Nepal. High antibiotic prescription rates have been reported among patients with all forms of COVID-19, including mild disease. Whereas the WHO Guidelines for Management of COVID-19 do not recommend antibiotics, evidence shows that most LMICs recommend them despite the lack of evidence to support the efficacy of antibiotics for treating mild COVID-19. The absence of affordable diagnostics worsens this situation since it encourages empirical antibiotic treatments.

This study will assess the impact of a package of interventions (point-of-care Rapid Diagnostic Tests-including COVID-19 Ag-RDTs, diagnostic algorithms, clinic flows, training and communication for patients and caregivers) on the prescription rates of antibiotics and clinical outcomes among patients presenting with acute febrile illnesses in Nepal.

The question addressed in this study will be:

• In patients presenting to outpatient clinics in Nepal with acute febrile illness/respiratory tract infection without focus and with a negative/positive RT-PCR for SARS-COV-2 (Population),
• by combining available diagnostic tests, diagnostic algorithms, adjusted clinic process flow and training & communication tools for caregivers and users (Intervention),
• over current practice (Control),
• Can we improve the management of acute febrile illnesses and better target the use of antibiotics / reduce unnecessary antibiotics prescriptions as appropriate and feasible (Outcome).

Primary Objective

To compare the impact of a package of interventions (diagnostic tools plus algorithms plus clinic process flow plus training and communication for caregivers and users) on clinical outcomes and antibiotic prescriptions, with standard-of-care practices, in children, adolescents and adults presenting with acute febrile illnesses (defined as fever less than seven days in duration either associated with an upper/lower respiratory tract infection or without any other focus and with a negative/positive RT-PCR for SARS-COV-2 ), at outpatient clinics in Nepal.

Secondary Objectives

1. To assess the adherence to new practices (interventions) by health care workers;
2. To assess the adherence to prescriptions by patients/caregivers at outpatient clinics;
3. To assess the safety of the package of interventions compared to the current practice of care;
4. To assess the feasibility of including COVID-19 Ag-RDT in the integrated diagnostic approach for acute febrile illness in health facilities.

Trial Population

1. Children, adolescents and adults presenting to the health care facility with a current or history of acute febrile illness (defined as fever less than seven days in duration either associated with an upper/lower respiratory tract infection or without any other focus and a negative/positive RT-PCR for SARS-COV-2);
2. Healthcare workers providing outpatient treatment of acute febrile illnesses;
3. Parents/Guardians of children and adolescents attending the health care facility with their child or adolescents.