Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia

• Sponsor: Zealand University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04279873
• Collaborator: Slagelse Hospital (Other)
• Enrollment: 22
• Location: 1
• Actual Duration (Months): 80
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Nosocomial pneumonia in the Intensive Care Unit is often not properly diagnosed mainly due to ongoing antimicrobial therapy. The study investigates the feasibility of more advanced diagnostic technics.

Condition or Disease	Intervention/Treatment	Phase
Nosocomial Pneumonia	Diagnostic Test: Microbiological diagnostics on pulmonary secretion

Detailed Description

ICU patients fulfilling the CDC criteria for nosocomial pneumonia and mechanically ventilated for no more than 24 hours are included in the study. The material for the diagnostic procedure is pulmonal secretion collected by 1. suctioning in the tracheal tube and 2. bronchioalveolar lavage. The diagnostic procedures are culturing, 16S and18S gene PCR and subsequent sequencing. The 3 diagnostic methods will be compared in order of proper diagnosis and the ability to determine a specific antimicrobial treatment.

Study Design

• Study Type: Observational
• Actual Enrollment: 22 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia in Patients Admitted to the Intensive Care Unit - an Exploratory Study
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Adults with nosocomial pneumonia Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage.	Diagnostic Test: Microbiological diagnostics on pulmonary secretion; Culture, 16s, 18s, next generation sequencing

Outcome Measures

Primary Outcome Measures

1. Ratio of patients where the advanced methods are superior to routine [1 day]

   Ratio of patients diagnosed by 16s, 18s or NGS to total number of patients compared to ratio of patients diagnosed by routine method (culture)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients intubated because of respiratory failure following nosocomial pneumonia

Exclusion Criteria:

• Terminal patients

• Patients with lung cancer

• Intubated for more than 24 hours at the sampling time

• Not fulfilling the CDC criteria for nosocomial pneumonia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zealand University Hospital	Køge	Region Sjælland	Denmark	4600

Sponsors and Collaborators

• Zealand University Hospital
• Slagelse Hospital

Investigators

• Principal Investigator: Lone Musaeus Poulsen, MD, Zealand University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT04279873
• Other Study ID Numbers: REG-048-2014; REG-48-2017
• First Posted: Feb 21, 2020
• Last Update Posted: Apr 22, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zealand University Hospital: Nosocomial, Pneumonia; Diagnostics; 16s; 18s; PCR; Next Generation Sequencing
• Additional relevant MeSH terms: Pneumonia; Healthcare-Associated Pneumonia

Study Results

No Results Posted as of Apr 22, 2021