NCT03191071

Brief Summary

The study is randomized clustered pragmatic trial whose objective is to decrease unnecessary antibiotic prescription in adult patients with lower respiratory tract infection managed at primary care level in Switzerland, using a simple algorithm based on 2 point of care test results

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
469

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

May 21, 2017

Last Update Submit

July 16, 2020

Conditions

Lower Resp Tract Infection

Keywords

pneumoniaprocalcitoninlung ultrasoundpoint of care testingantibiotic prescriptionrespiratory pathogenshost biomarkers

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients prescribed an antibiotic in each arm

    For each arm, we will assess the proportion of patient's prescribed an antibiotic following the consultation with the general practitioner. This will be done by recording the prescription decision of the general practitioner.

    Assessed at day 28 after baseline

Secondary Outcomes (11)

  • Duration of the episode

    Assessed at day 28 after baseline

  • Clinical failure

    Day 7 after baseline

  • Number of medical visits

    Day 7 and Day 28 after baseline

  • Serious adverse outcome

    During the first 28 days following baseline

  • Duration of algorithm completion

    Assessed at baseline (Day 0)

  • +6 more secondary outcomes

Study Arms (3)

UltraPro

EXPERIMENTAL

General practitioners randomly assigned to the UltraPro arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the UltraPro algorithm. The UltraPro algorithm combines the result of a procalcitonin point-of-care test with lung ultrasound result to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.

Diagnostic Test: UltraProDiagnostic Test: Blood samplingDiagnostic Test: Naso-pharyngeal swab and sputum culture

Procalcitonin

EXPERIMENTAL

General practitioners randomly assigned to the procalcitonin arm will be responsible to recruit patients fulfilling the inclusion criteria and manage them using the procalcitonin algorithm. The procalcitonin point-of-care test will be performed, as described above, to decide on antibiotic prescription. Blood sampling will be performed to identify potential novel biomarkers. Naso-pharyngeal swabs as well as sputum culture will allow for microbiologic identification of aetiological agents.

Diagnostic Test: ProcalcitoninDiagnostic Test: Blood samplingDiagnostic Test: Naso-pharyngeal swab and sputum culture

Usual Care

ACTIVE COMPARATOR

General practitioners randomly assigned to the usual care arm will be responsible to recruit patients fulfilling the inclusion criteria and will manage and treat these patients as they usually do. Only general practitioners who do not use procalcitonin and lung ultrasonography routinely will be included in the usual care arm. Naso-pharyngeal swabs as well as sputum culture will be performed to allow for microbiologic identification of aetiological agents.

Diagnostic Test: Naso-pharyngeal swab and sputum culture

Interventions

UltraProDIAGNOSTIC_TEST

First, procalcitonin will be measured using a rapid point-of-care test. In case of elevated procalcitonin result (≥0.25 µg/L), a lung ultrasound will be performed to look for the presence of a lung infiltrate or consolidation suggesting the presence of community acquired pneumonia. A portable ultrasound machine with a convex probe, that will be provided to the general practitioner by the study, will be used. The lung ultrasound will be done following international evidence-based recommendations for point-of-care lung ultrasound using the basic eight-region sonographic technique and the criteria for positive scan and positive examination for the diagnosis of pneumonia .

UltraPro
ProcalcitoninDIAGNOSTIC_TEST

Procalcitonin will be measured using a rapid point-of-care test

Procalcitonin
Blood samplingDIAGNOSTIC_TEST

A venous blood sample (17.5 mL) will be collected. Whole blood and plasma will be stored at - 80°C. Further analysis will be performed in order to identify novel biomarkers and gene transcription patterns that could predict the necessity of antibiotic prescription or the severity of disease.

ProcalcitoninUltraPro
Naso-pharyngeal swab and sputum cultureDIAGNOSTIC_TEST

A pooled nasal swab will be performed and sputum will be collected. Samples will be stored at -80°C. Further analysis of the naso-pharyngeal swab and cultures of sputum will be performed to identify by molecular techniques pathogens implicated in the clinical presentation.

ProcalcitoninUltraProUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent as documented by signature (Informed Consent Form)
  • Patients aged 18 years or more
  • No antibiotics prescribed for the current episode
  • Acute cough of up to 21 days duration and at least one of the following symptom or sign:
  • History of fever for more than 4 days
  • dyspnoea
  • tachypnoea (≥ 22 cycles per minutes)
  • abnormal focal finding during auscultation

You may not qualify if:

  • Previous prescription of antibiotics for the current episode
  • Working diagnosis of acute sinusitis or a non-infective disorder
  • Cystic fibrosis
  • Previous episode of chronic obstructive pulmonary disease exacerbation treated with antibiotics during the last 6 months
  • Known pregnancy
  • Severe immunodeficiency (untreated HIV infection with CD4 count \< 200 cells/mm3, solid organ transplant receiver, neutropenia, treatment with corticosteroids with dose equivalent to 20 mg prednisone/day for \> 28
  • Admission of the patient
  • GP not available for performing study
  • Patient unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1025, Switzerland

Location

Related Publications (3)

  • Geis D, Canova N, Lhopitallier L, Kronenberg A, Meuwly JY, Senn N, Mueller Y, Fasseur F, Boillat-Blanco N. Exploration of the Acceptance of the Use of Procalcitonin Point-of-Care Testing and Lung Ultrasonography by General Practitioners to Decide on Antibiotic Prescriptions for Lower Respiratory Infections: A Qualitative Study. BMJ Open. 2023 May 11;13(5):e063922. doi: 10.1136/bmjopen-2022-063922.

    PMID: 37169498DERIVED

  • Lhopitallier L, Kronenberg A, Meuwly JY, Locatelli I, Mueller Y, Senn N, D'Acremont V, Boillat-Blanco N. Procalcitonin and lung ultrasonography point-of-care testing to determine antibiotic prescription in patients with lower respiratory tract infection in primary care: pragmatic cluster randomised trial. BMJ. 2021 Sep 21;374:n2132. doi: 10.1136/bmj.n2132.

    PMID: 34548312DERIVED

  • Lhopitallier L, Kronenberg A, Meuwly JY, Locatelli I, Dubois J, Marti J, Mueller Y, Senn N, D'Acremont V, Boillat-Blanco N. Procalcitonin and lung ultrasonography point-of-care testing to decide on antibiotic prescription in patients with lower respiratory tract infection in primary care: protocol of a pragmatic cluster randomized trial. BMC Pulm Med. 2019 Aug 6;19(1):143. doi: 10.1186/s12890-019-0898-3.

    PMID: 31387559DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Noémie Boillat, PhD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized clustered pragmatic trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2017

First Posted

June 19, 2017

Study Start

September 1, 2018

Primary Completion

April 10, 2020

Study Completion

April 30, 2020

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

CH(1)