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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06511622
Enrollment
686
Registered
2024-07-22
Start date
2024-07-10
Completion date
2026-03-18
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Keywords

ARDS, ECMO, Herpes viridae

Brief summary

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.

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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Herpes simplex reactivation01/2019- 12/2025semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage
Cytomegalovirus reactivation01/2019- 12/2025as absolute copy number per milliliter of blood or bronchioalveolar lavage
Epstein Barr virus reactivation01/2019- 12/2025absolute copy number per milliliter of blood or bronchioalveolar lavage
B cells (CD19 positive)01/2019- 12/2025Absolute number per nanoliter and percentage of lymphocytes
Natural killer cells Cells (CD16 pos)01/2019- 12/2025Absolute number per nanoliter and percentage of lymphocytes.
T helper cells (CD4)01/2019- 12/2025Aabsolute number per nanoliter and percentage of lymphocytes
Cytotoxic T cells (CD8)01/2019- 12/2025Absolute number per nanoliter and percentage of lymphocytes
HLA-DR expression on monocytes01/2019- 12/2025in molecules per cell

Secondary

MeasureTime frameDescription
Beginn weaning01/2019- 12/2025Days until the first successful spontaneous breathing trial.
Extracorporeal membrane oxygenation duration01/2019- 12/2025Extracorporeal membrane oxygenation is measured in days
Costs of treatment01/2019- 12/2025Costs of treatment are measured by costs of particular microbiological diagnostics and therapy.
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
Mortality01/2019- 12/2025ITS mortality and hospital mortality are measured.
Sequential Organ Failure Assessment (SOFA score)01/2019- 12/2025Routine patient treatment data - score is measured numerically (0 - 24) Routine patient treatment data.
Simplified Acute Physiology Score (SAPS II)01/2019- 12/2025Routine patient treatment data - score is measured numerically (0 - 163)
Pre-existing conditions01/2019- 12/2025Classified recording of previous illnesses (e.g. haematological diseases, tumour diseases, chronic heart failure, etc.) from the medical file.
Concomitant infections with therapy01/2019- 12/2025Results of microbiological diagnostics (growth- and molecular-based diagnostics) by specifying the name of the pathogen.
Volumes01/2019- 12/2025Volumes administered, incl. transfusions and coagulation factors
Ventilation parameters01/2019- 12/2025Recording of ventilation parameters such as airway, ventilation mode and start of ventilation weaning.
Catecholamine doses01/2019- 12/2025Name of catecholamines, inotropes and vasopressors
Number of catecholamine days01/2019- 12/2025Number of days with dose of norepinephrine \> 0.1 µg/kg/min for more than 30 min or equivalent dose of other catecholamines.
Recording of end organ damage such as liver and kidney failure01/2019- 12/2025Organ damage measured by routine laboratory
Diagnoses during the intensive care stay01/2019- 12/2025Diagnoses as the cause of ARDS, but also newly acquired diagnoses such as critical illness myopathy / polyneuropathy, renal failure.
Administration of immunosuppressants01/2019- 12/2025Administration of immunosuppressants like corticosteroid, chemotherapy, monoclonal antibodies within the last 3 months.

Countries

Germany

Contacts

STUDY_DIRECTORClaudia Spies, MD, Prof.

Charite University, Berlin, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026