The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice (PARI)

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Status

Withdrawn

Conditions

Acute Respiratory Tract Infection

Treatments

Diagnostic Test: Procalcitonin

Study type

Interventional

Funder types

Other

Identifiers

NCT04216277

18057336

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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