An interventional study of Procalcitonin in Acute Respiratory Tract Infection, sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark. Withdrawn at 6 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
Procalcitonin values will be disclosed to the attending physician and assist in antibiotic guidance in addition to usual care
Diagnostic Test: Procalcitonin
Usual best standard care. No procalcitonin values disclosed to attending physician .
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
Duration of illness and symptoms from acute respiratory tract infections.
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).
Time frame: up to 14 days
Antibiotic treatments
Number of participants in each trial arm exposed to antibiotic treatment at index consultation (day 1) and within 30 days
Time frame: 1, 14 and 30 days
Side effects from antibiotic treatment
Number of participants in each trial arm with side effects from antibiotic treatment
Time frame: 14 days
re-consultations
Number of participants in each trial arm with re-consultations
Time frame: 30 days
Severe adverse effects
Number of participants in each trial arm admitted to hospitalization (including diagnosis and mortality)
Time frame: 30 days
Biomarker levels
Characterisation of biomarker (C-Reactive Protein and Procalcionin) levels at index consultation.
Time frame: day 1
Plan to share: Yes — work in progress
Supporting information: Study protocol, Sap, Analytic code
This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chronic Obstructive Pulmonary Disease Trial Network, Denmark