C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting
NCT ID: NCT01918579
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2037 participants
INTERVENTIONAL
2014-03-31
2015-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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CRP intervention
Patients will be tested by rapid POC CRP test
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.
Control
Patients will not be tested by rapid POC CRP test
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Suspected to have acute respiratory tract infection (ARI) by treating physician
* Informed consent
Exclusion Criteria
* 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.
6 Years
65 Years
ALL
No
Sponsors
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National Hospital for Tropical Diseases, Hanoi, Vietnam
OTHER_GOV
Oxford University Clinical Research Unit, Vietnam
OTHER
Responsible Party
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Principal Investigators
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Heiman FL Wertheim, M.D,Ph.D
Role: STUDY_DIRECTOR
Oxford University Clinical Research Unit
Locations
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National Hospital for Tropical Diseases
Hanoi, Hanoi, Vietnam
Countries
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References
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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.
Related Links
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Oxford University Clinical Research Unit, Viet Nam
Other Identifiers
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05HN
Identifier Type: -
Identifier Source: org_study_id