Preliminary Registration Detail

Research Registry No : PLRID-00878_V2
 
Postgraduate Research : No
 
University Departmental Research : Yes
 
Name of University : University of Oxford
 
Department : Myanmar Oxford Clinical Research Unit (Nuffield Department of Medicine)
 
Registration Date : 2020-07-29
 
Principle Investigator : Frank Smithuis
 
Co-Investigators : Ye Kyaw Si, Myo Maung Maung Swe, Phyu Hnin Hlaing, Aung Pyae Phyo, Alistair McLean, Ni Ni Tun, Htet Naing Lin
 
Title of Research : Impact of improved diagnostic tools, practices, training and communication tools on acute fever case management and antibiotic prescriptions for children, adolescents and adults at outpatient facilities: A multi-country study in Myanmar
 
Field of Research : Tropical and Infectious Diseases
 
Preliminary Research Design : Experimental Study
 
Preliminary Research Type : Applied
 
Preliminary Justification : To support the provision of UHC and contribute to reducing AMR, this project aims to influence current practice to improve the case management of acute febrile illness in children, adolescents and adults while influencing rational antibiotic prescribing practices and patients/parents/guardians intentions, expectations and behaviour around antibiotic use. For the purpose of this study, a practical definition of ‘acute febrile illness’ is fever with no focus or respiratory tract infection (RTI) lasting for no more than 7 days.
 
Preliminary Aim : To compare the impact of a package of intervention (point of care [PoC] tests, clinical algorithm, clinic process flow, communication messages) on clinical outcomes and antibiotic prescriptions, with standard-of-care practices, in children, adolescents and adults presenting with acute febrile illnesses (defined as fever with no focus or Respiratory Tract Infection lasting for no more than 7 days), at outpatient clinic
 
Preliminary Objectives : To assess the impact of interventions: 1. To improve the management of acute febrile illness 2. To enable 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 package of interventions compared to current practice of care 5. To understand the key drivers and barriers to deliver communication messages to patients/caregivers by health care workers. 6. To understand the key drivers and barriers to adherence to prescribing instructions by patients/caregivers 7. To evaluate the effectiveness of prescription related communication messages. 8. To understand the key drivers and barriers to adherence to new algorithms, use of point of care tests and prescribing based on test results
 
Preliminary Sample Size : 800 adults (≥ 18 yr) and 800 children/adolescents (>1 - < 18 yr)
 
Preliminary Study Duration : 18 months overall, including initial baseline qualitative study of 4-6 months and 12 months of intervention and patient recruitment
 
Preliminary Study Area : This study will be conducted in outpatient department (OPD) of Hlaing Thar Yar township hospital and three clinics supported by Medical Action Myanmar (MAM) in Hlaing Thar Yar and Shwe Pyi Thar townships in Yangon, Myanmar
 
Preliminary Study Method : A multi-centre, open label, two armed, 1:1, individually randomized-controlled trial
 
Preliminary Research Outcome : 1. Proportion of patients with resolution of illness (defined by no fever plus patient’s/ caregiver response as illness resolved/ markedly improved) at day 7 2. Proportion of patients who received antibiotic prescription on Day 0 and withi
 
Preliminary Research Finding : Not available at the moment
 
Preliminary Progress Report : Not available at the moment
 
Study Starting Date : 2020-08-31
IRB/PRC/ERC Approval Date : 2020-07-20
 
Placement of IRB/PRC/ERC : Department of Medical Research, Myanmar
 
IRB/PRC/ERC Approval Letter/Document : 290720200357102020-032Prof.FrankSmithuis.pdf
 
Pre-existing Registration ID : NCT04081051
 
Pre-existing Name of Organization : ClinicalTrials.Gov
 
Pre-existing Name of Organization Website : https://clinicaltrials.gov/