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The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice

NCT04216277 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-27

No results posted yet for this study

Summary

Antimicrobial resistance rates have reached alarming levels and the Worlds Health Organisation (WHO) states it constitutes a serious public health concern by threatening one of the most effective and mortality lowering interventions in modern medicine. Part of the solution to this problem includes minimizing overuse of antibiotics. But clinical signs alone are often not reliable to guide antibiotic treatment decisions and additional tests may be warranted to assist the doctor. Such tests include point-of-care biomarkers of infection like C-reactive protein (CRP) and procalcitonin (PCT). Targeting antibiotic use to the few patients with a high probability of benefit and withholding in the many with non-serious respiratory infection is a promising strategy and readily implemented in clinical practice.

The Procalcitonin guided Antibiotics in Respiratory Infections (PARI) study will assess the effect of a novel point-of-care PCT guided antibiotic stewardship in acute respiratory tract infections in general practice.

The overall aim of the PARI study is to reduce antibiotic use in patients with acute respiratory tract infections by targeting antibiotic treatment only to patients with a suspected bacterial etiology and thus likely to benefit from antibiotic therapy.

The main research questions are:

Does the addition of a point-of-care Procalcitonin test to standard care reduce antibiotic use in primary care? Is the intervention safe for the patients? The PARI study is a pragmatic two-arm (intervention and control (standard care) open randomized non-inferiority trial (up to 1 day difference in recovery) in general practice.

Conditions

  • Acute Respiratory Tract Infection

Interventions

DIAGNOSTIC_TEST

Procalcitonin

In addition to usual care diagnostic and handling of acute respiratory tract infections in general practice to attending physician in the intervention arm has access to antibiotic stewardship by a procalcitonin point-of-care test. The following criteria for initiating og withholding antibiotics will be used. * Antibiotics treatment is recommended with Procalcitonin levels above 0.25 ng/ml * Antibiotic treatment is discouraged if Procalcitonin levels are below 0.25 ng/ml

Sponsors & Collaborators

  • Research Unit Of General Practice, Copenhagen

    collaborator OTHER

  • Department of Public Health, Denmark

    collaborator OTHER

  • Chronic Obstructive Pulmonary Disease Trial Network, Denmark

    lead OTHER

Principal Investigators

  • Lars Bjerrum, PhD · Department of Public Health, Copenhagen University, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2022-08-01
Completion
2022-08-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216277 on ClinicalTrials.gov