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Completed

NCT Number: NCT03191071

An Algorithm to Decide on Antibiotic Prescription in Lower Respiratory Tract Infection in Primary Care

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

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Key information

Conditions

Lower Resp Tract Infection Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1025, Switzerland

About this study

The study will have two distinct phases:

The first phase will test the feasibility of the intervention (UltraPro) along a pilot study. Following the setup of a lung ultrasound training curriculum for general practitioners, the practicality of the whole UltraPro algorithm will be evaluated at primary care level.

The second phase will be a pragmatic randomized three-arm intervention study using an algorithm based on the results of procalcitonin and lung ultrasound to manage patients with lower respiratory tract infections at primary care level. The procalcitonin-ultrasound algorithm will be compared to procalcitonin-guided management alone and usual care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All patients presenting to a participating GP's office for a consultation for an acute respiratory infection (ARI) will be screened for inclusion in the study

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

UltraPro

Diagnostic 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 .

procalcitonin

Diagnostic Test

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

Blood sampling

Diagnostic 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.

Naso-pharyngeal swab and sputum culture

Diagnostic 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.

Primary outcomes

  1. Proportion of patients prescribed an antibiotic in each arm

    Time frame: Assessed at day 28 after baseline

    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.

Secondary outcomes

  1. Duration of the episode

    Time frame: Assessed at day 28 after baseline

    Number of days, within the first 28 days after enrolment, during which the patient's daily activities (work or recreation) were restricted by the lower respiratory tract infection. This will be assessed by telephone follow-up consultations

  2. Clinical failure

    Time frame: Day 7 after baseline

    Presence of symptoms of an ongoing or relapsing lower respiratory tract infection at 28 days after enrolment. This will be assessed by a telephone follow-up consultation.

  3. Number of medical visits

    Time frame: Day 7 and Day 28 after baseline

    The incidence of supplementary medical visits for the episode of lower respiratory tract infection within 28 days of enrolment will be assessed by reporting from the general practitioners and telephone follow-up consultations

  4. Serious adverse outcome

    Time frame: During the first 28 days following baseline

    Secondary hospitalisation or death of any cause or disease specific complications (lung abscess, empyema and acute respiratory distress), within 28 days of enrolment. Assessed by serious adverse event reporting, general practitioner reporting and telephone follow-up.

  5. Duration of algorithm completion

    Time frame: Assessed at baseline (Day 0)

    Median duration of time spent for the medical consultation, procalcitonin testing, lung ultrasound and total time spent in the practice. These will be assessed by the general practitioner by filling in a case report form at baseline.

  6. Satisfaction of providers

    Time frame: Assessed at baseline

    The overall satisfaction of general practitioners regarding the process of the consultation and its different components will be assessed using a Likert scale.

  7. Satisfaction of patients

    Time frame: Assessed at day 7

    The overall satisfaction of patients regarding the process of the consultation and of follow-up will be assessed using a Likert scale. These will be assessed by telephone follow-up.

  8. Cost / effectiveness ratio

    Time frame: Assessed one month after data collection is complete

    Cost / effectiveness ratio expressed as the cost required per 1% decrease of the rate of antibiotic prescription during the studio will be assessed using review of the medical records and estimation of the costs of the various process of the diagnostic algorithm based on the Swiss Federal HealthCare Law.

  9. Aetiology of LRTIs in primary care

    Time frame: Assessed within the first year after data collection is complete

    Prevalence of different respiratory pathogens as assessed by realtime multiplex PCR performed on a naso-pharyngeal swab and in sputum

  10. Host biomarkers

    Time frame: Assessed within the first year after data collection is complete

    Sensitivity and specificity of combinations of host biomarkers to identify patients with clinical failure or with pneumonia

  11. Transcription patterns

    Time frame: Assessed within the first year after data collection is complete

    Association between SNPs in genes involved in microvascular integrity and poor outcome or clinical failure

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Procalcitonin and Lung Ultrasonography Point-of-care Testing to Decide on Antibiotic Prescription in Patients With Lower Respiratory Tract Infection at Primary Care Level: Pragmatic Cluster Randomized Trial

Acronym: UltraPro

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2017
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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