An interventional study of Implementation group in Adults, Acute Respiratory Tract Infection and Antibiotic Prescriptions, sponsored by Oxford University Clinical Research Unit Indonesia. Recruiting at 8 sites in Indonesia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Oxford University Clinical Research Unit Indonesia · Not applicable, Interventional, and Diagnostic
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.
Representative sampling strategy and sample size calculation This research is aim to assess whether the implementation of CRP POCT reduces unnecessary antibiotic prescriptions for ARTI without increasing clinical failure by day seven. A total sample size of 2,544 patients is targeted, with an estimated 318 patients per PHC site and intraclass correlation coefficient of 0.002. This sample size is calculated using data from a prior study, where 7.7 percent of patients has clinical failure (proven by re-consultation in day 3) (pC = 0.077), the expected odds ratio comparing the new approach to standard is 1.25, a non-inferiority margin of 15%, equal implementation and standard ratio (k = 1), 80% power, a two-sided α = 0.05 and loss to follow up 10%.
The intracluster correlation coefficient (ICC) value of 0.002 used in the sample size calculation was derived from a previous stepped-wedge cluster randomized trial conducted in Tanzania. Although Tanzania and Indonesia are both classified as low- and middle-income countries (LMICs) and share several contextual similarities, such as resource constraints and primary health care-based service delivery, there are notable differences between the two settings, including the distribution of health facilities, workforce availability, and disease burden. As there are currently no published studies from Indonesia employing a similar cluster design in primary care settings, this ICC value was adopted as the most contextually comparable estimate available.
The 15% non-inferiority margin in this study represents a safety parameter for the implementation of CRP point-of-care testing. This margin refers to the acceptable difference in the proportion of patients who may require a follow-up visit to another healthcare facility and receive antibiotic treatment within seven days after the initial consultation. A 10-15% margin has been commonly applied in previous non-inferiority studies evaluating the clinical safety of CRP-guided antibiotic reduction strategies, reflecting an acceptable trade-off between reduced antibiotic use and clinical outcomes in mild acute respiratory infections.
Eligible facilities are those averaging ≥30 ARTI consultations per week and willing to participate. At the study initiation, none of the clusters will receive implementation (CRP POCT). Patient enrolment, baseline assessments, and case report form-based data collection will be conducted continuously throughout this transition and implementation period. Every two weeks, there will be transitions of the assigned group of PHC sites from standard group to implementation group. Over a total duration of 18 weeks, all clusters eventually receive the implementation, allowing for both within- and between-cluster comparisons.
The order of primary health centers (PHCs) transitioning to the CRP POCT implementation phase (Group 1 to Group 8) will be determined consecutively based on the sequence in which each PHC sites provides formal consent to participate in the implementation, following allocation approval by the Jakarta Provincial Health Office.
According to this design, all PHCs will experience two phases:
Data collection occurs at two key points:
All study outcomes will be analyzed using multilevel logistic regression models to account for clustering at the level of the primary health care PHC sites, with individual patients included as a second random effect when appropriate. Fixed-effect covariates will include adjusting for stratification variables used and for key baseline characteristics identified a priori as potential confounders or found to be imbalanced between study arms, especially among participants with and without available day 7 follow-up data. Covariates will include:
Outcomes assessed on day 0 will be analyzed in the per-protocol population, defined as participants with complete documentation of final treatment. Day 7 outcomes will be analyzed in both the per-protocol and complete-case populations (i.e., those with available follow-up data), and results will be reported for both unless otherwise specified.
Prespecified subgroup analyses will assess effect modification across sex, age categories, and presenting complaint types. All statistical analyses will be conducted using Stata software.
Oxford University Clinical Research Unit Indonesia is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Patients will be treated with usual care and with the addition of CRP point of care testing (POCT).
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.
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.
Time frame: 7 days
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
Time frame: 7 days
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.
Time frame: 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
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.
Time frame: 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
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
Time frame: 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
The proportion of patients who receive any additional antibiotic medication within 7 days following the initial consultation. This includes: 1. New antibiotic prescriptions from the same healthcare facility 2. Antibiotic prescriptions from other healthcare providers (including emergency departments, other primary care facilities, or specialists) 3. Changes in antibiotic regimen (switch to different antibiotic class or dose modification) Self-reported antibiotic use obtained from pharmacies or other sources
Time frame: 7 days
Plan to share: Yes — Datasets will be stored in online repositories managed by the OUCRU Indonesia. A record of all datasets generated, with relevant metadata, will be created using the platform, and this will facilitate easy identification and retrieval of datasets. Dedicated information technology team of OUCRU ID will manage and ensure all data is findable, accessible, interoperable, and reproducible. We will also provide the integrated study data and share the report with the Ministry of Health of the Republic of Indonesia and the Jakarta Provincial Health Office.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Oct 2026, 6 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oxford University Clinical Research Unit Indonesia