Acute Respiratory Tract InfectionPARINCT04216277
The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice
A study testing Procalcitonin in people with Acute Respiratory Tract Infection, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 6 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Tract Infection
- What is being tested?
- Procalcitonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesDenmark
- Study dates
- 27 Feb 2020to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Lægerne Finne, Riise og Aabenhus
Copenhagen, 1620
Amagercentrets læger
Copenhagen, 2300
Mit Lægehus
Copenhagen, 2610
Haslev Lægecenter
Haslev, 4690
Næstved Lægecenter
Næstved, 4700
Rønnede lægehus
Rønnede, 4683
About this study
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.
Read more
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
- Being tested
- Procalcitonin
- Keywords
- primary care, acute respiratory tract infection, Procalcitonin, general practice, Antibiotic use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcalcitoninDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Procalcitonin |
| Usual care | No intervention | Usual best standard care. No procalcitonin values disclosed to attending physician . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 14 days
Secondary outcomes (5)
Antibiotic treatments
Number of participants in each trial arm exposed to antibiotic treatment at index consultation (day 1) and within 30 days
Measured: 1, 14 and 30 days
Side effects from antibiotic treatment
Number of participants in each trial arm with side effects from antibiotic treatment
Measured: 14 days
re-consultations
Number of participants in each trial arm with re-consultations
Measured: 30 days
Severe adverse effects
Number of participants in each trial arm admitted to hospitalization (including diagnosis and mortality)
Measured: 30 days
Biomarker levels
Characterisation of biomarker (C-Reactive Protein and Procalcionin) levels at index consultation.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start27 Feb 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Why it stopped: the poc test was withdrawn by manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit Of General Practice, Copenhagen, Department of Public Health, Denmark
- Responsible party
- Principal investigator, Rune Munck Aabenhus, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Investigators
- Lars Bjerrum, PhD, Study chair, Department of Public Health, Copenhagen University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216277
- Sponsor's protocol ID
- 18057336
- Acronym
- PARI
- Status last verified
- Mar 2023
- First submitted
- 12 Dec 2019
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: work in progress
Publications
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.
PubMed 35279069
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice
- ClinicalTrials.gov ID
- NCT04216277
- Acronym / sponsor ID
- PARI / 18057336
- Conditions
- Acute Respiratory Tract Infection
- Keywords
- primary care, acute respiratory tract infection, Procalcitonin, general practice, Antibiotic use
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the poc test was withdrawn by manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, DenmarkUniversity, hospital or other
- Collaborators
- Research Unit Of General Practice, Copenhagen, Department of Public Health, Denmark
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin in addition to usual care | Experimental | Diagnostic Test: ProcalcitoninProcalcitonin values will be disclosed to the attending physician and assist in antibiotic guidance in addition to usual care |
| Usual care | No intervention | –Usual best standard care. No procalcitonin values disclosed to attending physician . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProcalcitoninIn 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 | Diagnostic test | Procalcitonin in addition to usual care |
Primary outcome
Duration of illness and symptoms from acute respiratory tract infections.
Time frame: 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).
5 secondary outcomes
Antibiotic treatments
Time frame: 1, 14 and 30 days
Side effects from antibiotic treatment
Time frame: 14 days
re-consultations
Time frame: 30 days
Severe adverse effects
Time frame: 30 days
Biomarker levels
Time frame: day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 35279069Filipsen 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.
- Individual participant dataSharing planned: Yes. work in progress
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Bjerrum, PhD study chair
Department of Public Health, Copenhagen University, Denmark
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin in people with Acute Respiratory Tract Infection, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of illness and symptoms from acute respiratory tract infections. (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.