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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Infections
• Intervention / Treatment: Procedure: Patients will be tested by rapid POC CRP test

• Study Type: Interventional
• Enrollment (Actual): 2037
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 10000
    • National Hospital for Tropical Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRP intervention; Patients will be tested by rapid POC CRP test	Procedure: Patients will be tested by rapid POC CRP test; 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.
No Intervention: Control; Patients will not be tested by rapid POC CRP test

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The attitudes and satisfaction of patients and health center staff towards the test.	Patients and health center staff will be interviewed by structured questionnaire to assess their attitudes and satisfaction toward the intervention. The Likert scale will be used for quantifying attitude orientation of interviewees	2 weeks

Collaborators and Investigators

• Sponsor: Oxford University Clinical Research Unit, Vietnam
• Collaborators: National Hospital for Tropical Diseases, Hanoi, Vietnam
• Investigators: Study Director: Heiman FL Wertheim, M.D,Ph.D, Oxford University Clinical Research Unit

Publications and helpful links

General Publications

• Haenssgen MJ, Charoenboon N, Do NTT, Althaus T, Khine Zaw Y, Wertheim HFL, Lubell Y. How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials. 2019 Feb 8;20(1):111. doi: 10.1186/s13063-019-3215-9.
• Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3. Erratum In: Lancet Glob Health. 2017 Jan;5(1):e39.

Helpful Links

• Oxford University Clinical Research Unit, Viet Nam

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 13, 2016
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: 05HN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No