Clinical trial NCT04216277: The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice
Official title: The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Respiratory Tract Infection
Keywords: primary care
acute respiratory tract infection
Procalcitonin
general practice
Antibiotic use
Lead sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Sponsor class: OTHER
Collaborators: name: Research Unit Of General Practice, Copenhagen
name: Department of Public Health, Denmark
First posted: 2020-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration of illness and symptoms from acute respiratory tract infections.
timeFrame: up to 14 days
Secondary outcomes:
measure: Antibiotic treatments
timeFrame: 1, 14 and 30 days
measure: Side effects from antibiotic treatment
timeFrame: 14 days
measure: re-consultations
timeFrame: 30 days
measure: Severe adverse effects
timeFrame: 30 days
measure: Biomarker levels
timeFrame: day 1
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Lægerne Finne, Riise og Aabenhus
city: Copenhagen
country: Denmark
facility: Amagercentrets læger
city: Copenhagen
country: Denmark
facility: Mit Lægehus
city: Haslev
country: Denmark
facility: Haslev Lægecenter
city: Næstved
country: Denmark
facility: Næstved Lægecenter
city: Rønnede
country: Denmark
facility: Rønnede lægehus
Study officials:
affiliation: Department of Public Health, Copenhagen University, Denmark
name: Lars Bjerrum, PhD
role: STUDY_CHAIR
References:
citation: Filipsen N, Bro H, Bjerrum L, Jensen JS, Aabenhus R. The Procalcitonin-guided Antibiotics in Respiratory Infections (PARI) project in general practice - a study protocol. BMC Prim Care. 2022 Mar 12;23(1):43. doi: 10.1186/s12875-022-01646-6.