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Tetracycline to Limit the Innate Immune Response in Acute Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04079426
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
Dr. Christian Bode, University of Bonn

Brief Summary:
The acute respiratory distress syndrome (ARDS) is a severe form of respiratory failure with a mortality rate of approximately 40%. Despite advances in its supportive treatment such as lung protective ventilation or restrictive fluid management, no effective pharmacotherapy exists to treat ARDS. Emerging preclinical data indicates that excessive activation of the inflammasome-Caspase 1 pathway plays a key role in the development of ARDS. Tetracycline has anti-inflammatory properties via inhibiting inflammasome-caspase-1 activation. Since not much is known about the activation of the inflammasome in clinical ARDS, the purpose of this study is i) to investigate the the inflammasome-caspase-1 activation in clinical ARDS and ii) inhibit the innate immune response of alveolar leucocytes obtained by tetracycline from patients with ARDS

Condition or disease Intervention/treatment
Adult Respiratory Distress Syndrome Pneumonia Sepsis Other: Sampling of Blood and bronchoalveolar lavage

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Innate Immunity in Acute Respiratory Distress Syndrome: A Translational Approach to Limit Inflammasome-dependent Lung Inflammation by Tetracycline
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Intervention Details:
  • Other: Sampling of Blood and bronchoalveolar lavage
    Multiplex assays for pro- and anti-inflammatory markers and incubation of immune cells isolated from serum and bronchoalveolar lavage fluid of patients with ARDS.

Primary Outcome Measures :
  1. Cytokine Levels in Serum and bronchoalveolar fluid [ Time Frame: 1 week ]
    determined by multiplex Assay [pg/ml]

  2. Activation Status of immune cells from blood and bronchoalveolar fluid [ Time Frame: 1 week ]
    incubation of immune cells with tetracycline and Determination of cytokines by multiplex assay [pg/ml]

  3. Alarmins in Serum and bronchoalveolar fluid [ Time Frame: 1 week ]
    Determination by western blot, qPCR or flow cytometry

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants admitted to the Intensive Care Unit of the University Hospital of Bonn with an initial diagnosis of ARDS

Inclusion Criteria:

  • Age > 18 years
  • Informed consent of the patient
  • Diagnosis of ARDS for < 48 h

Exclusion Criteria:

  • Age < 18 years
  • Missing informed consent
  • Immune therapy
  • Autoimmune disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04079426

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Contact: Christian Bode, Dr +49228287 ext 14119

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University Hospital Bonn Recruiting
Bonn, Germany, 53127
Contact: Chrisitan Bode, MD    +4922828714119   
Sponsors and Collaborators
University of Bonn

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Responsible Party: Dr. Christian Bode, Principal Investigator, University of Bonn Identifier: NCT04079426    
Other Study ID Numbers: BOST-002
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Christian Bode, University of Bonn:
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action