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| Name | Class |
|---|---|
| National Hospital for Tropical Diseases, Hanoi, Vietnam | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRP intervention | Experimental | Patients will be tested by rapid POC CRP test |
|
| Control | No Intervention | Patients will not be tested by rapid POC CRP test |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients will be tested by rapid POC CRP test | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of symptoms | Number of days that symptoms (including fever or any respiratory symptom) endure. | 2 weeks |
| Frequency of re-consultation | Number of visits to a health care practitioner during the 14 day follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Heiman FL Wertheim, M.D,Ph.D | Oxford University Clinical Research Unit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital for Tropical Diseases | Hanoi | Hanoi | 10000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30736818 | Derived | 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. | |
| 27495137 | Derived | 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. |
| Label | URL |
|---|---|
| Oxford University Clinical Research Unit, Viet Nam | View source |
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| 2 weeks |
| Frequency of serious adverse events | Number of serious adverse events which occur during the 14 day follow-up period. | 2 weeks |