Acute Respiratory Infections
Conditions
Brief 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.
Interventions
PROCEDUREPatients 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
National Hospital for Tropical Diseases, Hanoi, Vietnam
Oxford University Clinical Research Unit, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients receiving any antibiotic | 2 weeks | Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of serious adverse events | 2 weeks | Number of serious adverse events which occur during the 14 day follow-up period. |
| Duration of symptoms | 2 weeks | Number of days that symptoms (including fever or any respiratory symptom) endure. |
| Frequency of re-consultation | 2 weeks | Number of visits to a health care practitioner during the 14 day follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The attitudes and satisfaction of patients and health center staff towards the test. | 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 |
Countries
Vietnam
Outcome results
None listed