Impact on the Use of Antibiotics of a Multimodal Algorithm for the Diagnosis and Management of Acute Community-acquired Pneumonia in the Emergency Room

NCT05657275 | Completed

• 1 other identifier: APHP221018
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 2

Brief Summary

Reducing antibiotics prescription is still to date, the main goal in low respiratory tract infections (LRTI). Several studies have shown conflicting results on the impact of multiplex PCR as a point of care tool. Our experience has highlighted an impact on single room assignments during the winter season but not yet on antibiotics prescriptions. This project aims to evaluate a new multimodal algorithm including multiplex PCR at the point of care to reduce antibiotics prescription and therefore has the ability to have a positive impact on antibiotics resistance phenomenon.

Conditions

Community-acquired Pneumonia

Keywords

CRP dosage; multiplex PCR; chest scan without injection

Outcome Measures

Primary Outcomes (1)

• Total duration (in days) of pulmonary-targeted antibiotic therapy

  day 30

Secondary Outcomes (8)

• Total duration of hospitalization (in days)

  day 30

• Proportion of patients who died within 30 days

  day 30

• Proportion of patients rehospitalized within 30 days

  day 30

• Proportion of patients hospitalized in a single room

  day 30

• Proportion of patients with initiation of pulmonary-targeted antibiotic treatment in the emergency department

  day 1

Study Arms (2)

Intervention period

EXPERIMENTAL

Patient management will be guided by a multimodal algorithm integrating the performance of biological and iconographic examinations

Diagnostic Test: CRP dosage; Diagnostic Test: multiplex PCR; Diagnostic Test: chest scan without injection

Control period

NO INTERVENTION

Patient management will be done according to the usual practices of centers and emergency physicians

Interventions

CRP dosage DIAGNOSTIC_TEST

multimodal algorithm

Intervention period

multiplex PCR DIAGNOSTIC_TEST

multimodal algorithm

Intervention period

chest scan without injection DIAGNOSTIC_TEST

multimodal algorithm

Intervention period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 18 years or older
• Presence of at least one respiratory sign among the following: dyspnea, cough, expectoration, auscultatory abnormalities, chest pain;
• Presence of at least one general sign among the following: fever (T\>38°C), hypothermia (T\<35°C), myalgia, headache, asthenia;
• Oxygen-requiring patient defined by a saturation \<95% or presenting a risk area among:
• Age \> 65 years old
• Alcoholic and/or tobacco intoxication
• Congestive heart failure
• Cerebrovascular disease (stroke or transient ischemic attack)
• Chronic kidney disease (excluding dialysis)
• Chronic liver disease
• Unbalanced diabetes mellitus
• Progressive neoplastic disease
• Immunodepression (systemic corticosteroid therapy or immunosuppressive treatment within 6 months, splenectomy, chemotherapy within 6 months, HIV at the AIDS stage, cachexia, etc.)
• Homozygous sickle cell disease
• Bacterial pneumonia

You may not qualify if:

• RT-PCR positive for SARS-CoV-2

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• QIAGEN Gaithersburg, Inc: collaborator

Study Sites (2)

CHU Nîmes

Nîmes, France

Location

Bichat hospital

Paris, France

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Donia BOUZID

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Chronological series in alternating periods, that is to say alternations of periods of more or less short duration, with and without intervention corresponding to a repetition of before/after studies will be carried

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 20, 2022
• Study Start: January 9, 2023
• Primary Completion: May 13, 2024
• Study Completion: June 11, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)