The C-reactive Protein (CRP) Point of Care Testing (POCT) Implementation to Adult Patients Presenting With Symptoms of the Acute Respiratory Tract Infection (ARTI) in Eight Primary Health Care (PHC) in Jakarta.
NCT07717372 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2544
Last updated 2026-07-21
Summary
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.
Conditions
- Adults
- Acute Respiratory Tract Infection
- Antibiotic Prescriptions
Interventions
- DIAGNOSTIC_TEST
-
Implementation group
Patients 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.
Sponsors & Collaborators
-
Dr Cipto Mangunkusumo General Hospital
collaborator OTHER -
Fakultas Kedokteran Universitas Indonesia
collaborator OTHER -
Oxford University Clinical Research Unit, Vietnam
collaborator OTHER -
Oxford University Clinical Research Unit Indonesia
lead OTHER
Principal Investigators
-
Robert Sinto, MD, DPhil · Dr Cipto Mangunkusumo General Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-06
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
Countries
- Indonesia
Study Locations
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