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 | Recruiting

• 2 other identifiers: OUCRU-ID.2025.006230GRSE10IND
• Study Type: interventional
• Target: 2,544
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

antibiotics; Accute Respiratory Track Infections; primary health care; Antibiotic prescribing; C-reactive protein point of care testing

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (5)

• Measure proportion of patients with antibiotic prescription stratified by CRP level in implementation (CRP tested) versus standard (non-CRP tested) groups

  7 days

• Compare proportion of patients with hospitalization within 7 days in implementation (CRP tested) versus standard (non-CRP tested) groups

  7 days

• Compare proportion of patients with unscheduled reattendance at any health facility by day 7 in implementation (CRP tested) versus standard (non-CRP tested) groups

  7 days

• Compare proportion of patients with subjective clinical worsening on day 7 following initial consultation in implementation (CRP tested) versus standard (non-CRP tested) groups

  7 days

• Compare proportion of measure additional antibiotic medication prescriptions within 7 days of the initial consultation in implementation (CRP tested) versus standard (non-CRP tested) groups

  7 days

Study Arms (2)

Standard Group

NO INTERVENTION

Patients will be treated in accordance with current standards of care for acute respiratory tract infections without the use of CRP point of care testing (POCT).

Implementation group

EXPERIMENTAL

Patients will be treated with usual care and with the addition of CRP point of care testing (POCT).

Diagnostic Test: Implementation group

Interventions

Implementation group DIAGNOSTIC_TEST

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.

Implementation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Clinical Research Unit Indonesia: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator
• Fakultas Kedokteran Universitas Indonesia: collaborator
• Oxford University Clinical Research Unit, Vietnam: collaborator

Study Sites (8)

Cengkareng Public Health Center

Jakarta, 11730, Indonesia

RECRUITING

Kebayoran Lama Public Health Center

Jakarta, 12240, Indonesia

ENROLLING BY INVITATION

Pulo Gadung Public Health Center

Jakarta, 13220, Indonesia

RECRUITING

Jatinegara Public Health Center

Jakarta, 13310, Indonesia

RECRUITING

Duren Sawit Public Health Center

Jakarta, 13440, Indonesia

RECRUITING

Cakung Public Health Center

Jakarta, 13930, Indonesia

RECRUITING

Cilincing Public Health Center

Jakarta, 14120, Indonesia

RECRUITING

Koja Public Health Center

Jakarta, 14260, Indonesia

RECRUITING

Study Officials

• Robert Sinto, MD, DPhil

  Dr Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Sinto, MD, DPhil

CONTACT

+622123599099; rsinto@oucru.org

Raph L Hamers, MD, PhD

CONTACT

+622123599099; rhamers@oucru.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: We plan to assess whether CRP POCT can safely decrease unnecessary antibiotic use in acute respiratory tract infections without raising the incidence of clinical failure by day 7. A total sample size of 2,544 patients is targeted, with an estimated 318 patients per PHC site. According to this design, all PHCs will experience two phases: 1. Standard phase: Patients will be treated in accordance with current standards of care for acute respiratory tract infections without the use of CRP point of care testing (POCT). 2. Implementation phase: Patients will be treated with usual care and with the addition of CRP point of care testing (POCT). 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.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 21, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

ID (8)