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

Vaud University Hospital Center

Status: Completed

Conditions: Lower Resp Tract Infection

Treatments: Diagnostic Test: Naso-pharyngeal swab and sputum culture; Diagnostic Test: Blood sampling; Diagnostic Test: Procalcitonin; Diagnostic Test: UltraPro

Study type: Interventional

Funder types: Other

Identifiers

NCT03191071

SNF 407240_167133/1

Details and patient eligibility

About

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

Full 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.

Enrollment: 469 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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469 participants in 3 patient groups

UltraPro

Experimental group

Description:

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.

Treatment:

Diagnostic Test: UltraPro

Diagnostic Test: Naso-pharyngeal swab and sputum culture

Diagnostic Test: Blood sampling

Procalcitonin

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Procalcitonin

Diagnostic Test: Naso-pharyngeal swab and sputum culture

Diagnostic Test: Blood sampling

Usual Care

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Naso-pharyngeal swab and sputum culture