The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-27

Study Completion Date

2022-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Procalcitonin will be measured on all participants but none of the participants will be informed about the results of the procalcitonin value or the randomisation and thus remain unaware of allocated group status (intervention or control).

Study Groups

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Procalcitonin in addition to usual care

Procalcitonin values will be disclosed to the attending physician and assist in antibiotic guidance in addition to usual care

Group Type EXPERIMENTAL

Procalcitonin

Intervention Type DIAGNOSTIC_TEST

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

Usual care

Usual best standard care. No procalcitonin values disclosed to attending physician .

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age above 18 years
* Able to read and understand patient information about the PARI trial and willing to give written informed consent prior to enrollment
* Acute cough e.g. less than 2 weeks probable acute upper or lower respiratory tract infection (pharyngitis, tonsillitis, otitis media, sinusitis, exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), bronchitis or pneumonia)
* C-Reactive Protein \>20 mg/m

Exclusion Criteria

* Symptoms present for more than 2 weeks
* Verified immunodeficiency or presently neutropenic (neutrophile granulocytes ≤0,5 x 109/L within the last 7 days)
* Severe liver failure
* Severe kidney failure including dialysis
* Sore throat and positive test for Group A streptococcus
* Prior antibiotic exposure last 14 days up to inclusion
* Need for acute admission to hospital
* Pregnancy or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No