The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice

Acute Respiratory Tract Infection Clinical Trial

— PARI  

Official title:

The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04216277
• Other study ID #: 18057336
• Status: Withdrawn
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2023
• Source: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Tract Infection
• Communicable Diseases
• Infections
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• Procalcitonin
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

Locations

Country	Name	City	State
Denmark	Amagercentrets læger	Copenhagen
Denmark	Lægerne Finne, Riise og Aabenhus	Copenhagen
Denmark	Mit Lægehus	Copenhagen
Denmark	Haslev Lægecenter	Haslev
Denmark	Næstved Lægecenter	Næstved
Denmark	Rønnede lægehus	Rønnede

Sponsors (3)

Lead Sponsor	Collaborator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark	Department of Public Health, Denmark, Research Unit Of General Practice, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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