Lower Resp Tract InfectionUltraProNCT03191071
An Algorithm to Decide on Antibiotic Prescription in Lower Respiratory Tract Infection in Primary Care
A study testing UltraPro, Procalcitonin and Blood sampling in people with Lower Resp Tract Infection, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Resp Tract Infection
- What is being tested?
- UltraPro, Procalcitonin and Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2018to 30 Apr 2020
- 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
- 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
Who cannot join
- 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
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- Admission of the patient
- GP not available for performing study
- Patient unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1025
About this study
Official 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
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
Read the detailed description
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.
- Conditions
- Lower Resp Tract Infection
- Being tested
- UltraPro, Procalcitonin, Blood sampling, Naso-pharyngeal swab and sputum culture
- Keywords
- pneumonia, procalcitonin, lung ultrasound, point of care testing, antibiotic prescription, respiratory pathogens, host biomarkers
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 .
ProcalcitoninDiagnostic test
Procalcitonin will be measured using a rapid point-of-care test
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: UltraPro; Diagnostic Test: Blood sampling; Diagnostic 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. Receives: Diagnostic Test: Procalcitonin; Diagnostic Test: Blood sampling; Diagnostic 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. Receives: Diagnostic Test: Naso-pharyngeal swab and sputum culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at day 28 after baseline
Secondary outcomes (11)
Duration of the episode
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
Measured: Assessed at day 28 after baseline
Clinical failure
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.
Measured: Day 7 after baseline
Number of medical visits
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
Measured: Day 7 and Day 28 after baseline
Serious adverse outcome
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.
Measured: During the first 28 days following baseline
Duration of algorithm completion
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.
Measured: Assessed at baseline (Day 0)
Satisfaction of providers
The overall satisfaction of general practitioners regarding the process of the consultation and its different components will be assessed using a Likert scale.
Measured: Assessed at baseline
Satisfaction of patients
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.
Measured: Assessed at day 7
Cost / effectiveness ratio
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.
Measured: Assessed one month after data collection is complete
Aetiology of LRTIs in primary care
Prevalence of different respiratory pathogens as assessed by realtime multiplex PCR performed on a naso-pharyngeal swab and in sputum
Measured: Assessed within the first year after data collection is complete
Host biomarkers
Sensitivity and specificity of combinations of host biomarkers to identify patients with clinical failure or with pneumonia
Measured: Assessed within the first year after data collection is complete
Transcription patterns
Association between SNPs in genes involved in microvascular integrity and poor outcome or clinical failure
Measured: Assessed within the first year after data collection is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Sep 2018
- Primary completion10 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lower Resp Tract InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Model description
- Randomized clustered pragmatic trial
- Masking
- None (open label)
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Boillat-Blanco Noemie, Centre Hospitalier Universitaire Vaudois
- Investigators
- Noémie Boillat, PhD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191071
- Sponsor's protocol ID
- SNF 407240_167133/1
- Acronym
- UltraPro
- Status last verified
- Jul 2020
- First submitted
- 21 May 2017
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only coded and anonymous data will be made available to protect patients right to privacy
Publications
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.
PubMed 37169498Lhopitallier 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.
PubMed 34548312Lhopitallier 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.
PubMed 31387559
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03191071
- Acronym / sponsor ID
- UltraPro / SNF 407240_167133/1
- Conditions
- Lower Resp Tract Infection
- Keywords
- pneumonia, procalcitonin, lung ultrasound, point of care testing, antibiotic prescription, respiratory pathogens, host biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 19 Jun 2017 (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.
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
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized clustered pragmatic trial
| Arm | Type | Receives |
|---|---|---|
| UltraPro | Experimental | Diagnostic Test: UltraPro, Diagnostic Test: Blood sampling, Diagnostic Test: Naso-pharyngeal swab and sputum cultureGeneral 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. |
| Procalcitonin | Experimental | Diagnostic Test: Procalcitonin, Diagnostic Test: Blood sampling, Diagnostic Test: Naso-pharyngeal swab and sputum cultureGeneral 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. |
| Usual Care | Active comparator | Diagnostic Test: Naso-pharyngeal swab and sputum cultureGeneral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| UltraProFirst, 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 . | Diagnostic test | UltraPro |
| ProcalcitoninProcalcitonin will be measured using a rapid point-of-care test | Diagnostic test | Procalcitonin |
| Blood samplingA 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. | Diagnostic test | Procalcitonin, UltraPro |
| Naso-pharyngeal swab and sputum cultureA 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. | Diagnostic test | Procalcitonin, UltraPro, Usual Care |
Primary outcome
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.
11 secondary outcomes
Duration of the episode
Time frame: Assessed at day 28 after baseline
Clinical failure
Time frame: Day 7 after baseline
Number of medical visits
Time frame: Day 7 and Day 28 after baseline
Serious adverse outcome
Time frame: During the first 28 days following baseline
Duration of algorithm completion
Time frame: Assessed at baseline (Day 0)
Satisfaction of providers
Time frame: Assessed at baseline
Satisfaction of patients
Time frame: Assessed at day 7
Cost / effectiveness ratio
Time frame: Assessed one month after data collection is complete
Aetiology of LRTIs in primary care
Time frame: Assessed within the first year after data collection is complete
Host biomarkers
Time frame: Assessed within the first year after data collection is complete
Transcription patterns
Time frame: Assessed within the first year after data collection is complete
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Derived from this study: PubMed 37169498Geis 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.
- Derived from this study: PubMed 34548312Lhopitallier 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.
- Derived from this study: PubMed 31387559Lhopitallier 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.
- Individual participant dataSharing planned: Undecided. Only coded and anonymous data will be made available to protect patients right to privacy
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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.
Noémie Boillat, PhD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraPro, Procalcitonin and Blood sampling in people with Lower Resp Tract Infection, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients prescribed an antibiotic in each arm (time frame: Assessed at day 28 after baseline). 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 NCT03191071, which also lists 3 linked publications.
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 17 Jul 2020.