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C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting (CRP)

Primary Purpose

Acute Respiratory Infections

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Patients will be tested by rapid POC CRP test
Sponsored by
Oxford University Clinical Research Unit, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Infections

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • National Hospital for Tropical Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CRP intervention

Control

Arm Description

Patients will be tested by rapid POC CRP test

Patients will not be tested by rapid POC CRP test

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of symptoms
Number of days that symptoms (including fever or any respiratory symptom) endure.
Frequency of re-consultation
Number of visits to a health care practitioner during the 14 day follow-up.
Frequency of serious adverse events
Number of serious adverse events which occur during the 14 day follow-up period.

Full Information

First Posted
August 6, 2013
Last Updated
November 13, 2016
Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
National Hospital for Tropical Diseases, Hanoi, Vietnam
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1. Study Identification

Unique Protocol Identification Number
NCT01918579
Brief Title
C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting
Acronym
CRP
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
National Hospital for Tropical Diseases, Hanoi, Vietnam

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2037 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRP intervention
Arm Type
Experimental
Arm Description
Patients will be tested by rapid POC CRP test
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will not be tested by rapid POC CRP test
Intervention Type
Procedure
Intervention Name(s)
Patients will be tested by rapid POC CRP test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients receiving any antibiotic
Description
Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Duration of symptoms
Description
Number of days that symptoms (including fever or any respiratory symptom) endure.
Time Frame
2 weeks
Title
Frequency of re-consultation
Description
Number of visits to a health care practitioner during the 14 day follow-up.
Time Frame
2 weeks
Title
Frequency of serious adverse events
Description
Number of serious adverse events which occur during the 14 day follow-up period.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
The attitudes and satisfaction of patients and health center staff towards the test.
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiman FL Wertheim, M.D,Ph.D
Organizational Affiliation
Oxford University Clinical Research Unit
Official's Role
Study Director
Facility Information:
Facility Name
National Hospital for Tropical Diseases
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
30736818
Citation
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.
Results Reference
derived
PubMed Identifier
27495137
Citation
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. Erratum In: Lancet Glob Health. 2017 Jan;5(1):e39.
Results Reference
derived
Links:
URL
http://www.oucru.org
Description
Oxford University Clinical Research Unit, Viet Nam

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C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting

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