C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting

Study Overview
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Brief Summary
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Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence of antibiotic abuse for community acute respiratory infection has been reported. This study will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory illness at primary healthcare stations reduces inappropriate antibiotic use safely. The study will be conducted at ten district health care facilities in Hanoi, Viet Nam. Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute respiratory infection. Patients will be randomly allocated to the control or the intervention arm. Participants in the control group will be treated according to routine care. Participants in the intervention arm will have a CRP test, the results of which will be available to the health care practitioner to contribute to their diagnosis and treatment decisions. All patients will be followed-up via telephone call after 14 days. The study will compare the proportion of patients in each arm receiving any antibiotics within 2 weeks of study enrollment.

Official Title
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Efficacy of Point-of-care (POC) C-reactive Protein Testing to Reduce Inappropriate Use of Antibiotics for Acute Respiratory Infections (ARIs) in the Primary Health Care Setting of Hanoi - a Randomized Controlled Trial

Conditions
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Acute Respiratory Infections

Intervention / Treatment
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* Procedure: Patients will be tested by rapid POC CRP test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, aged 6 to 65 years, that visit one of the 10 selected primary healthcare centers Suspected to have acute respiratory tract infection (ARI) by treating physician Informed consent Exclusion Criteria: Severe respiratory disease as determined by treating doctor Any disease or symptom requiring hospital referral as determined by treating doctor Immunosuppressed patients (e.g. HIV, long term steroid use) Suspicion of tuberculosis Evidence of acute or chronic liver disease (e.g. hepatitis or cirrhosis due to any cause) Past medical history of: neoplastic disease, congestive cardiac failure, chronic obstructive pulmonary disease, insulin-dependent diabetes or renal disease Pregnancy No access to telephone Not able to come for follow up visit on day 3 or 4. Already taking antibiotics at the time of presentation Symptoms present for more than 2 weeks Presence of any sign of severe diseases as defined by the British Thoracic Society modified CRP-65 system for severity scoring of pneumonia in primary care. For children (Age ≥ 6 years and < 16 years) additional exclusion criteria include: Tachypnea, signs of chest wall in drawing, reduced consciousness, confusion, dehydration, hypothermia, severe malnutrition, unable to feed or drink, vomiting, and convulsions.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRP intervention<br>Patients will be tested by rapid POC CRP test | Procedure: Patients will be tested by rapid POC CRP test<br>* Patient will be tested with CRP test. Treatment decisions including any antibiotics prescribed will be based on test results and clinical judgement. Treatment choices are not recommended/prescribed by the study protocol.<br>|
| No Intervention: Control<br>Patients will not be tested by rapid POC CRP test | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients receiving any antibiotic | Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of symptoms | Number of days that symptoms (including fever or any respiratory symptom) endure. | 2 weeks | 
| Frequency of re-consultation | Number of visits to a health care practitioner during the 14 day follow-up. | 2 weeks | 
| Frequency of serious adverse events | Number of serious adverse events which occur during the 14 day follow-up period. | 2 weeks |