The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice

Not Applicable

Withdrawn

• Conditions: Acute Respiratory Tract Infection
• Interventions: Diagnostic Test: Procalcitonin

• Registration Number: NCT04216277
• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2020-02-27
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Duration of illness and symptoms from acute respiratory tract infections.	up to 14 days	The patient reported primary outcome will be assessed as number of days to a patient's daily activities (work or recreation) are no longer restricted by symptoms from a respiratory tract infection.The non-inferiority margin between the intervention and control group is set at a one day difference. The recovery measure will be the specific day indicated by the participants using the validated Acute Respiratory Tract Infections Questionaire (ARTIQ).

Secondary Outcome Measures

Name	Time	Method
Severe adverse effects	30 days	Number of participants in each trial arm admitted to hospitalization (including diagnosis and mortality)
Antibiotic treatments	1, 14 and 30 days	Number of participants in each trial arm exposed to antibiotic treatment at index consultation (day 1) and within 30 days
Side effects from antibiotic treatment	14 days	Number of participants in each trial arm with side effects from antibiotic treatment
re-consultations	30 days	Number of participants in each trial arm with re-consultations
Biomarker levels	day 1	Characterisation of biomarker (C-Reactive Protein and Procalcionin) levels at index consultation.

Trial Locations

Locations (6)

Mit Lægehus; 🇩🇰 Copenhagen, Denmark

Lægerne Finne, Riise og Aabenhus; 🇩🇰 Copenhagen, Denmark

Amagercentrets læger; 🇩🇰 Copenhagen, Denmark

Haslev Lægecenter; 🇩🇰 Haslev, Denmark

Næstved Lægecenter; 🇩🇰 Næstved, Denmark

Rønnede lægehus; 🇩🇰 Rønnede, Denmark