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

NCT01918579 | Completed DMC

• 1 other identifier: 05HN
• Study Type: interventional
• Target: 2,037
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Infections

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Duration of symptoms

  2 weeks

• Frequency of re-consultation

  2 weeks

• Frequency of serious adverse events

  2 weeks

Other Outcomes (1)

• The attitudes and satisfaction of patients and health center staff towards the test.

  2 weeks

Study Arms (2)

CRP intervention

EXPERIMENTAL

Patients will be tested by rapid POC CRP test

Procedure: Patients will be tested by rapid POC CRP test

Control

NO INTERVENTION

Patients will not be tested by rapid POC CRP test

Interventions

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.

CRP intervention

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• National Hospital for Tropical Diseases, Hanoi, Vietnam: collaborator

Study Sites (1)

National Hospital for Tropical Diseases

Hanoi, Hanoi, 10000, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 30736818 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.

  PMID: 27495137 DERIVED

Related Links

• Oxford University Clinical Research Unit, Viet Nam

Study Officials

• Heiman FL Wertheim, M.D,Ph.D

  Oxford University Clinical Research Unit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 7, 2013
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 15, 2016

Record last verified: 2014-06

Locations

VN (1)