Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904223
Status:
RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-05-23
Brief Title:
Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay
Sponsor:
Alexander Zoufaly
Organization:
Klinik Favoriten
Study Overview
Official Title:
Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay - INHALE Trial
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INHALE
Brief Summary:
Does the use of the BIOFIRE FILMARRAY Pneumonia Panel plus in hospitalized patients with lower respiratory infections lead to a reduction in length of hospital stay LOS and customized antibiotic treatment higher amount of specific vs empiric treatment shorter treatment duration less antibiotic treatment lower incidence of side effects compared to the standard of care
Detailed Description:
Lower respiratory tract infections LRTIs like pneumonia exacerbations of COPD or bronchitis are caused by several viral andor bacterial pathogens Even in huge epidemiological studies the causative pathogen can just be detected in approximately 50 of pneumonia cases In clinical practice the pathogen is only known in few cases eg Legionella via urine antigen test It is impossible to distinguish the triggering bacteria by clinical parameters and even accurate differentiation between bacterial and viral infections is often not possible The same problem exists for other LRTIs
The lack of knowledge of the causative pathogen leads to several problems
First clinicians tend to observe patients after treatment initiation for a longer period than probably necessary which may lead to an increased length of hospital stay Secondly the antibiotic treatment has to be broad enough to cover all possible pathogens empirically This might lead to an overuse of broad-spectrum antibiotics an increased risk of side effects the development of antibiotic resistance or even delayed treatment of the causative agent Finally antibiotics are prescribed erroneously for viral infections which have been misinterpreted as bacterial infections by clinicians
The BIOFIRE FILMARRAY Pneumonia Panel plus can help to solve these problems by identifying the causative pathogen in LRTIs within 15 hours The decision of the treatment and its duration would be pathogen driven and no longer just empirically based on a lot of unknown factors
The investigators would like to perform the following study with two groups standard of care control group vs Pneumonia panel plus intervention group Both groups will receive the standard of care treatment but the intervention group will additionally have their sputum analyzed via the BIOFIRE FILMARRAY Pneumonia Panel plus
Additional information empiric vs specific treatment
empiric therapy - every antimicrobial therapy prescribed without knowing the pathogen
o AmoxicillinClavulanic acid or Cefuroxime or CeftriaxoneCefotaxime or PiperacillinTazobactam or Levofloxacin
Specific therapy - pathogen driven prescribed knowing the pathogen narrowed spectrum of agent
Pneumococcus - Penicillin G
H influenzae - Cefuroxime or Doxycycline
Moraxella - Cefuroxime or Doxycycline
MSSA - Cefazolin or Flucloxacillin
MRSA - Linezolid or Vancomycin
Pseudomonas - Ceftazidime
E coli - Cefuroxime or third generation Cephalosporin or Ciprofloxacin
Klebsiella - Cefuroxime or third generation Cephalosporin or Ciprofloxacin
Proteus Serratia - third generation Cephalosporin or Ciprofloxacin
Enterobacter cloacae - Ertapenem
Legionella - Levofloxacin or Azithromycin
Mycoplasma - Azithromycin or Doxycycline
In case of ESBLs - Ertapenem or Meropenem
In case of carbapenemases - CeftazidimeAvibactam OXA48 KPC or MeropenemVaborbactam KPC or Aztreonam - CeftazidimeAvibactam MBL - others
The lack of knowledge of the causative pathogen leads to several problems
First clinicians tend to observe patients after treatment initiation for a longer period than probably necessary which may lead to an increased length of hospital stay Secondly the antibiotic treatment has to be broad enough to cover all possible pathogens empirically This might lead to an overuse of broad-spectrum antibiotics an increased risk of side effects the development of antibiotic resistance or even delayed treatment of the causative agent Finally antibiotics are prescribed erroneously for viral infections which have been misinterpreted as bacterial infections by clinicians
The BIOFIRE FILMARRAY Pneumonia Panel plus can help to solve these problems by identifying the causative pathogen in LRTIs within 15 hours The decision of the treatment and its duration would be pathogen driven and no longer just empirically based on a lot of unknown factors
The investigators would like to perform the following study with two groups standard of care control group vs Pneumonia panel plus intervention group Both groups will receive the standard of care treatment but the intervention group will additionally have their sputum analyzed via the BIOFIRE FILMARRAY Pneumonia Panel plus
Additional information empiric vs specific treatment
empiric therapy - every antimicrobial therapy prescribed without knowing the pathogen
o AmoxicillinClavulanic acid or Cefuroxime or CeftriaxoneCefotaxime or PiperacillinTazobactam or Levofloxacin
Specific therapy - pathogen driven prescribed knowing the pathogen narrowed spectrum of agent
Pneumococcus - Penicillin G
H influenzae - Cefuroxime or Doxycycline
Moraxella - Cefuroxime or Doxycycline
MSSA - Cefazolin or Flucloxacillin
MRSA - Linezolid or Vancomycin
Pseudomonas - Ceftazidime
E coli - Cefuroxime or third generation Cephalosporin or Ciprofloxacin
Klebsiella - Cefuroxime or third generation Cephalosporin or Ciprofloxacin
Proteus Serratia - third generation Cephalosporin or Ciprofloxacin
Enterobacter cloacae - Ertapenem
Legionella - Levofloxacin or Azithromycin
Mycoplasma - Azithromycin or Doxycycline
In case of ESBLs - Ertapenem or Meropenem
In case of carbapenemases - CeftazidimeAvibactam OXA48 KPC or MeropenemVaborbactam KPC or Aztreonam - CeftazidimeAvibactam MBL - others
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None