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Completed

NCT Number: NCT06511622

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.

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Key information

Conditions

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Herpes simplex reactivation

    Time frame: 01/2019- 12/2025

    semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage

  2. Cytomegalovirus reactivation

    Time frame: 01/2019- 12/2025

    as absolute copy number per milliliter of blood or bronchioalveolar lavage

  3. Epstein Barr virus reactivation

    Time frame: 01/2019- 12/2025

    absolute copy number per milliliter of blood or bronchioalveolar lavage

  4. B cells (CD19 positive)

    Time frame: 01/2019- 12/2025

    Absolute number per nanoliter and percentage of lymphocytes

  5. Natural killer cells Cells (CD16 pos)

    Time frame: 01/2019- 12/2025

    Absolute number per nanoliter and percentage of lymphocytes.

  6. T helper cells (CD4)

    Time frame: 01/2019- 12/2025

    Aabsolute number per nanoliter and percentage of lymphocytes

  7. Cytotoxic T cells (CD8)

    Time frame: 01/2019- 12/2025

    Absolute number per nanoliter and percentage of lymphocytes

  8. HLA-DR expression on monocytes

    Time frame: 01/2019- 12/2025

    in molecules per cell

Secondary outcomes

  1. Beginn weaning

    Time frame: 01/2019- 12/2025

    Days until the first successful spontaneous breathing trial.

  2. Extracorporeal membrane oxygenation duration

    Time frame: 01/2019- 12/2025

    Extracorporeal membrane oxygenation is measured in days

  3. Costs of treatment

    Time frame: 01/2019- 12/2025

    Costs of treatment are measured by costs of particular microbiological diagnostics and therapy.

  4. Pathogen persistence after guideline-compliant therapy (yes/no)

    Time frame: 01/2019- 12/2025

  5. Ventilator-associated pneumonia (yes/no)

    Time frame: 01/2019- 12/2025

  6. Occurrence of fungal pneumonia (yes/no)

    Time frame: 01/2019- 12/2025

  7. Mortality

    Time frame: 01/2019- 12/2025

    ITS mortality and hospital mortality are measured.

  8. Sequential Organ Failure Assessment (SOFA score)

    Time frame: 01/2019- 12/2025

    Routine patient treatment data - score is measured numerically (0 - 24) Routine patient treatment data.

  9. Simplified Acute Physiology Score (SAPS II)

    Time frame: 01/2019- 12/2025

    Routine patient treatment data - score is measured numerically (0 - 163)

  10. Pre-existing conditions

    Time frame: 01/2019- 12/2025

    Classified recording of previous illnesses (e.g. haematological diseases, tumour diseases, chronic heart failure, etc.) from the medical file.

  11. Concomitant infections with therapy

    Time frame: 01/2019- 12/2025

    Results of microbiological diagnostics (growth- and molecular-based diagnostics) by specifying the name of the pathogen.

  12. Volumes

    Time frame: 01/2019- 12/2025

    Volumes administered, incl. transfusions and coagulation factors

  13. Ventilation parameters

    Time frame: 01/2019- 12/2025

    Recording of ventilation parameters such as airway, ventilation mode and start of ventilation weaning.

  14. Catecholamine doses

    Time frame: 01/2019- 12/2025

    Name of catecholamines, inotropes and vasopressors

  15. Number of catecholamine days

    Time frame: 01/2019- 12/2025

    Number of days with dose of norepinephrine > 0.1 µg/kg/min for more than 30 min or equivalent dose of other catecholamines.

  16. Recording of end organ damage such as liver and kidney failure

    Time frame: 01/2019- 12/2025

    Organ damage measured by routine laboratory

  17. Diagnoses during the intensive care stay

    Time frame: 01/2019- 12/2025

    Diagnoses as the cause of ARDS, but also newly acquired diagnoses such as critical illness myopathy / polyneuropathy, renal failure.

  18. Administration of immunosuppressants

    Time frame: 01/2019- 12/2025

    Administration of immunosuppressants like corticosteroid, chemotherapy, monoclonal antibodies within the last 3 months.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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