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Completed

NCT Number: NCT01918579

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

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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Key information

Conditions

Acute Respiratory Infections

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital for Tropical Diseases

Hanoi, 10000, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duration of symptoms

    Time frame: 2 weeks

    Number of days that symptoms (including fever or any respiratory symptom) endure.

  2. Frequency of re-consultation

    Time frame: 2 weeks

    Number of visits to a health care practitioner during the 14 day follow-up.

  3. Frequency of serious adverse events

    Time frame: 2 weeks

    Number of serious adverse events which occur during the 14 day follow-up period.

Other outcomes

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

    Time frame: 2 weeks

    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

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • National Hospital for Tropical Diseases, Hanoi, Vietnam

Registry information

Official study 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

Acronym: CRP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2013
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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