C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting (CRP)
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|ClinicalTrials.gov Identifier: NCT01918579|
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : November 15, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Infections||Procedure: Patients will be tested by rapid POC CRP test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2037 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||September 2015|
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
- Proportion of patients receiving any antibiotic [ Time Frame: 2 weeks ]Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients.
- Duration of symptoms [ Time Frame: 2 weeks ]Number of days that symptoms (including fever or any respiratory symptom) endure.
- Frequency of re-consultation [ Time Frame: 2 weeks ]Number of visits to a health care practitioner during the 14 day follow-up.
- Frequency of serious adverse events [ Time Frame: 2 weeks ]Number of serious adverse events which occur during the 14 day follow-up period.
- The attitudes and satisfaction of patients and health center staff towards the test. [ Time Frame: 2 weeks ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918579
|National Hospital for Tropical Diseases|
|Hanoi, Vietnam, 10000|
|Study Director:||Heiman FL Wertheim, M.D,Ph.D||Oxford University Clinical Research Unit|