Acute Respiratory InfectionsCRPNCT01918579
C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting
A study testing Patients will be tested by rapid POC CRP test in people with Acute Respiratory Infections, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Acute Respiratory Infections
- What is being tested?
- Patients will be tested by rapid POC CRP test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,037 participants
- Where
- 1 siteVietnam
- Study dates
- Mar 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Patients will be tested by rapid POC CRP test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be tested by rapid POC CRP testProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CRP intervention | Experimental | Patients will be tested by rapid POC CRP test Receives: Procedure: Patients will be tested by rapid POC CRP test |
| Control | No intervention | Patients will not be tested by rapid POC CRP test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (3)
Duration of symptoms
Number of days that symptoms (including fever or any respiratory symptom) endure.
Measured: 2 weeks
Frequency of re-consultation
Number of visits to a health care practitioner during the 14 day follow-up.
Measured: 2 weeks
Frequency of serious adverse events
Number of serious adverse events which occur during the 14 day follow-up period.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital for Tropical Diseases, Hanoi, Vietnam
- Responsible party
- Sponsor
- Investigators
- Heiman FL Wertheim, M.D,Ph.D, Study director, Oxford University Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918579
- Sponsor's protocol ID
- 05HN
- Acronym
- CRP
- Status last verified
- Jun 2014
- First submitted
- 6 Aug 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30736818Do 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.
PubMed 27495137
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01918579
- Acronym / sponsor ID
- CRP / 05HN
- Conditions
- Acute Respiratory Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,037 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- National Hospital for Tropical Diseases, Hanoi, Vietnam
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRP intervention | Experimental | Procedure: Patients will be tested by rapid POC CRP testPatients will be tested by rapid POC CRP test |
| Control | No intervention | –Patients will not be tested by rapid POC CRP test |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients will be tested by rapid POC CRP testPatient 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. | Procedure or surgery | CRP intervention |
Primary outcome
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.
3 secondary outcomes
Duration of symptoms
Time frame: 2 weeks
Frequency of re-consultation
Time frame: 2 weeks
Frequency of serious adverse events
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 30736818Haenssgen 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.
- Derived from this study: PubMed 27495137Do 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.
- Oxford University Clinical Research Unit, Viet NamLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiman FL Wertheim, M.D,Ph.D study director
Oxford University Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will be tested by rapid POC CRP test in people with Acute Respiratory Infections, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients receiving any antibiotic (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.