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

NCT01918579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2037

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Infections

Interventions

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.

Sponsors & Collaborators

  • National Hospital for Tropical Diseases, Hanoi, Vietnam

    collaborator OTHER_GOV

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Heiman FL Wertheim, M.D,Ph.D · Oxford University Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918579 on ClinicalTrials.gov