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

Acute Respiratory Infections Clinical Trial

— CRP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918579
• Other study ID #: 05HN
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: November 13, 2016
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2014
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Hanoi Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2037
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Respiratory Infections
• Infection
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Vietnam	National Hospital for Tropical Diseases	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	National Hospital for Tropical Diseases, Hanoi, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	Duration of symptoms	Number of days that symptoms (including fever or any respiratory symptom) endure.	2 weeks	No
Secondary	Frequency of re-consultation	Number of visits to a health care practitioner during the 14 day follow-up.	2 weeks	No
Secondary	Frequency of serious adverse events	Number of serious adverse events which occur during the 14 day follow-up period.	2 weeks	No

External Links

•   Oxford University Clinical Research Unit, Viet Nam