The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice

NCT04216277 | Withdrawn DMC

• 1 other identifier: 18057336
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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.

Conditions

Acute Respiratory Tract Infection

Keywords

primary care; acute respiratory tract infection; Procalcitonin; general practice; Antibiotic use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Antibiotic treatments

  1, 14 and 30 days

• Side effects from antibiotic treatment

  14 days

• re-consultations

  30 days

• Severe adverse effects

  30 days

• Biomarker levels

  day 1

Study Arms (2)

Procalcitonin in addition to usual care

EXPERIMENTAL

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

Diagnostic Test: Procalcitonin

Usual care

NO INTERVENTION

Usual best standard care. No procalcitonin values disclosed to attending physician .

Interventions

Procalcitonin DIAGNOSTIC_TEST

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

Procalcitonin in addition to usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Need for acute admission to hospital
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Chronic Obstructive Pulmonary Disease Trial Network, Denmark: lead
• Research Unit Of General Practice, Copenhagen: collaborator
• Department of Public Health, Denmark: collaborator

Study Sites (6)

Lægerne Finne, Riise og Aabenhus

Copenhagen, 1620, Denmark

Location

Amagercentrets læger

Copenhagen, 2300, Denmark

Location

Mit Lægehus

Copenhagen, 2610, Denmark

Location

Haslev Lægecenter

Haslev, 4690, Denmark

Location

Næstved Lægecenter

Næstved, 4700, Denmark

Location

Rønnede lægehus

Rønnede, 4683, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35279069 DERIVED

Study Officials

• Lars Bjerrum, PhD

  Department of Public Health, Copenhagen University, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Procalcitonin will be measured on all participants but none of the participants will be informed about the results of the procalcitonin value or the randomisation and thus remain unaware of allocated group status (intervention or control).
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Specialist in General Practice, PhD, Assistent Professor

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: January 2, 2020
• Study Start: February 27, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Upon publication of study results

Locations

DK (6)