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

Lower Resp Tract Infection Clinical Trial

— UltraPro  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191071
• Other study ID #: SNF 407240_167133/1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: April 30, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lower Resp Tract Infection
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• UltraPro
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
Procalcitonin will be measured using a rapid point-of-care test
• Blood sampling
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
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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Assessed at day 28 after baseline
Secondary	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.	Day 7 after baseline
Secondary	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	Day 7 and Day 28 after baseline
Secondary	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.	During the first 28 days following baseline
Secondary	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.	Assessed at baseline (Day 0)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed at day 7
Secondary	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.	Assessed one month after data collection is complete
Secondary	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	Assessed within the first year after data collection is complete
Secondary	Host biomarkers	Sensitivity and specificity of combinations of host biomarkers to identify patients with clinical failure or with pneumonia	Assessed within the first year after data collection is complete
Secondary	Transcription patterns	Association between SNPs in genes involved in microvascular integrity and poor outcome or clinical failure	Assessed within the first year after data collection is complete