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NCT04216277: PARI

The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice

Withdrawn NA Last updated 27 March 2023
What this trial tests

NA trial testing Procalcitonin in Acute Respiratory Tract Infection. Withdrawn.

Timeline
27 February 2020
Primary endpoint
1 August 2022
1 August 2022

Quick facts

Lead sponsorChronic Obstructive Pulmonary Disease Trial Network, Denmark
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposediagnostic
Start date27 February 2020
Primary completion1 August 2022
Estimated completion1 August 2022
Sites6 locations across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Who can join

18 and older, any sex, with Acute Respiratory Tract Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Biomarkers as point-of-care tests to guide prescription of antibiotics in people with acute respiratory infections in primary care.
    Smedemark SA, Aabenhus R, Llor C, Fournaise A, et al · · 2022 · cited 66× · PMID 36250577 · DOI 10.1002/14651858.cd010130.pub3
  2. The Procalcitonin-guided Antibiotics in Respiratory Infections (PARI) project in general practice - a study protocol.
    Filipsen N, Bro H, Bjerrum L, Jensen JS, et al · · 2022 · cited 2× · PMID 35279069 · DOI 10.1186/s12875-022-01646-6

Verify or expand the search:

Other trials of Procalcitonin

Trials testing the same drug.

Other recruiting trials for Acute Respiratory Tract Infection

Currently open trials in the same condition.

Other Chronic Obstructive Pulmonary Disease Trial Network, Denmark trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04216277.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing