Antimicrobial resistance (AMR) has emerged as one of the most pressing global health challenges of the 21st century, particularly Indonesia is projected to be among the five nations globally with the highest percentage increase in antimicrobial consumption by 2030. Primary care settings represent the most critical implementation point for addressing inappropriate antibiotic use. ARTI constitutes the most common indication for antibiotic prescribing in primary care, yet much of this prescribing is inappropriate. The high frequency of inappropriate antibiotic prescribing for ARTI is particularly problematic because most of these infections are viral in nature and resolve spontaneously without antibiotic treatment. Studies across the Asia-Pacific region, including Indonesia, have documented antibiotic prescribing rates for upper respiratory tract infections ranging from 47% to 85%, indicating substantial overuse.
C-reactive protein (CRP) point-of-care test (POCT) has emerged as a promising, evidence-based implementation to reduce inappropriate antibiotic prescribing for acute respiratory infections in a systematic review of studies conducted primarily in primary care settings of high- and middle-income countries. However, the efficacy and safety of CRP POCT implementation have not been evaluated in Indonesian primary care settings, where healthcare infrastructure, patient populations, test acceptability, and prescribing practices may differ significantly from countries where studies have been conducted.
This research will fill a critical evidence gap by providing the first rigorous evaluation of CRP POCT in the Indonesian context. The findings will directly inform Indonesia's National Strategy for AMR Standard and provide evidence-based guidance for scaling antimicrobial stewardship implementations across Indonesian PHC sites. Reducing inappropriate antibiotic prescribing by implementing CRP will contribute to reduce the development of antimicrobial resistance, unnecessary adverse effects, and healthcare costs.
Adults aged ≥18 years.
Presenting to the PHC site for the first consultation of the current episode of Acute-Respiratory Tract Infections (ARTI).
Reporting at least one of the following symptoms or clinical signs within the past 5 days: cough, rhinitis (e.g., sneezing, nasal congestion, or runny nose), pharyngitis (e.g., sore throat), shortness of breath, wheezing, chest pain, abnormal lung sounds on auscultation.
Presenting with severe illness requiring referral to a higher-level healthcare facility (e.g., hospital).
Having known immunosuppression or chronic conditions, including but not limited to: HIV infection; chronic liver disease; history of malignancy; long-term use of systemic corticosteroids or other immunosuppressive therapies, as assessed by the healthcare worker or study team.
Having taken antibiotics prior to the visit to the primary health center.
Sequential
Implementation group
Diagnostic testPatients will be treated with usual care and with the addition of CRP point-of-care testing (POCT). The testing process will use the ACTIM CRP® test and comply with ISO 13485 and MDSAP 13845 quality management system standards and is CE-marked for in vitro diagnostic use. CRP testing will be conducted by a trained research assistant who will be assigned on-site at each primary health care. The CRP POCT results will be provided to the treating physician as additional information to support clinical decision-making. The decision to prescribe antibiotics will remain based on the clinical decisions.
Compare the proportion of patients prescribed antibiotics at initial consultation in implementation (CRP tested) versus standard (non-CRP tested) groups
The proportion of enrolled adult patients with ARTI who were prescribed any antibiotic during their first consultation at a participating PHC site.
Measure proportion of patients with antibiotic prescription stratified by CRP level in implementation (CRP tested) versus standard (non-CRP tested) groups
Proportion of patients prescribed an antibiotic in the implementation arm with: 1. CRP \<10 mg/L 2. 10 mg/L \< CRP \< 40 mg/L 3. CRP \>40 mg/L
Compare proportion of patients with hospitalization within 7 days in implementation (CRP tested) versus standard (non-CRP tested) groups
The proportion of patients who were hospitalized at any point within 7 days following the initial consultation at a study facility, regardless of referral status.
Compare proportion of patients with unscheduled reattendance at any health facility by day 7 in implementation (CRP tested) versus standard (non-CRP tested) groups
The proportion of patients who made an unplanned visit to any health facility (public or private) for the same or worsening illness within 7 days after the initial consultation. Scheduled follow-up visits or referrals are not included.
Compare proportion of patients with subjective clinical worsening on day 7 following initial consultation in implementation (CRP tested) versus standard (non-CRP tested) groups
The proportion of patients who report subjective worsening of their clinical condition on day 7 following the initial consultation. This includes: 1. Worsening of symptom severity (increased cough, sputum production, shortness of breath, chest pain, or fever) 2. Deterioration in functional status or daily activities Patient's overall perception of clinical improvement versus worsening
Click on the lead sponsor to view all of their trials.
Oxford University Clinical Research Unit Indonesia
Lead sponsor
Dr Cipto Mangunkusumo General Hospital
Sponsor institution
Dr Cipto Mangunkusumo General Hospital
Collaborator
Fakultas Kedokteran Universitas Indonesia
Collaborator
Oxford University Clinical Research Unit, Vietnam
Collaborator
