Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure

This is a retrospective observational study over the period 1/2019 - 02/2024 with the aim of identifying patients with a predisposition to secondary infections.

Study Overview

• Status: Completed
• Conditions: ARDS

Detailed Description

As a reference center, Charité Universitaetsmedizin Berlin has been treating patients with the most severe form of acute respiratory failure, known as acute respiratory distress syndrome (ARDS), for more than 30 years. Despite lung-protective forms of ventilation and the use of extracorporeal procedures for oxygenation and decarboxylation (ECMO), mortality is around forty percent. In addition to the primary cause of ARDS, further infectious complications often develop during the course of the disease, which delay recovery.

The aim of this study is to investigate infectious complications (ventilator-associated pneumonia, reactivation of Herpes viridae, pathogen resistance despite formally correct therapy, fungal infections) depending on the immune status.

• Study Type: Observational
• Enrollment (Actual): 686

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Male and female patients who received intensive care treatment for acute respiratory distress syndrome on ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days.

Description

Inclusion Criteria:

• Male and female acute respiratory distress syndrome patients who had an immune status within 48 h of admission
• Patients who received intensive care treatment for acute respiratory distress syndrome ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Herpes simplex reactivation	semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage	01/2019- 12/2025
Cytomegalovirus reactivation	as absolute copy number per milliliter of blood or bronchioalveolar lavage	01/2019- 12/2025
Epstein Barr virus reactivation	absolute copy number per milliliter of blood or bronchioalveolar lavage	01/2019- 12/2025
B cells (CD19 positive)	Absolute number per nanoliter and percentage of lymphocytes	01/2019- 12/2025
Natural killer cells Cells (CD16 pos)	Absolute number per nanoliter and percentage of lymphocytes.	01/2019- 12/2025
T helper cells (CD4)	Aabsolute number per nanoliter and percentage of lymphocytes	01/2019- 12/2025
Cytotoxic T cells (CD8)	Absolute number per nanoliter and percentage of lymphocytes	01/2019- 12/2025
HLA-DR expression on monocytes	in molecules per cell	01/2019- 12/2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beginn weaning	Days until the first successful spontaneous breathing trial.	01/2019- 12/2025
Extracorporeal membrane oxygenation duration	Extracorporeal membrane oxygenation is measured in days	01/2019- 12/2025
Costs of treatment	Costs of treatment are measured by costs of particular microbiological diagnostics and therapy.	01/2019- 12/2025
Pathogen persistence after guideline-compliant therapy (yes/no)		01/2019- 12/2025
Ventilator-associated pneumonia (yes/no)		01/2019- 12/2025
Occurrence of fungal pneumonia (yes/no)		01/2019- 12/2025
Mortality	ITS mortality and hospital mortality are measured.	01/2019- 12/2025
Sequential Organ Failure Assessment (SOFA score)	Routine patient treatment data - score is measured numerically (0 - 24) Routine patient treatment data.	01/2019- 12/2025
Simplified Acute Physiology Score (SAPS II)	Routine patient treatment data - score is measured numerically (0 - 163)	01/2019- 12/2025
Pre-existing conditions	Classified recording of previous illnesses (e.g. haematological diseases, tumour diseases, chronic heart failure, etc.) from the medical file.	01/2019- 12/2025
Concomitant infections with therapy	Results of microbiological diagnostics (growth- and molecular-based diagnostics) by specifying the name of the pathogen.	01/2019- 12/2025
Volumes	Volumes administered, incl. transfusions and coagulation factors	01/2019- 12/2025
Ventilation parameters	Recording of ventilation parameters such as airway, ventilation mode and start of ventilation weaning.	01/2019- 12/2025
Catecholamine doses	Name of catecholamines, inotropes and vasopressors	01/2019- 12/2025
Number of catecholamine days	Number of days with dose of norepinephrine > 0.1 µg/kg/min for more than 30 min or equivalent dose of other catecholamines.	01/2019- 12/2025
Recording of end organ damage such as liver and kidney failure	Organ damage measured by routine laboratory	01/2019- 12/2025
Diagnoses during the intensive care stay	Diagnoses as the cause of ARDS, but also newly acquired diagnoses such as critical illness myopathy / polyneuropathy, renal failure.	01/2019- 12/2025
Administration of immunosuppressants	Administration of immunosuppressants like corticosteroid, chemotherapy, monoclonal antibodies within the last 3 months.	01/2019- 12/2025

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): March 18, 2026
• Study Completion (Actual): March 18, 2026

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ARDS; ECMO; Herpes viridae
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Coinfection
• Other Study ID Numbers: ARDS-Infectio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No