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Trial record 13 of 201 for:    TETRACYCLINE

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.
 
ClinicalTrials.gov Identifier: NCT04079426
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Christian Bode, University of Bonn

Tracking Information
First Submitted Date August 29, 2019
First Posted Date September 6, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date January 4, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2019)
  • Cytokine Levels in Serum and bronchoalveolar fluid [ Time Frame: 1 week ]
    determined by multiplex Assay [pg/ml]
  • 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]
  • Alarmins in Serum and bronchoalveolar fluid [ Time Frame: 1 week ]
    Determination by western blot, qPCR or flow cytometry
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tetracycline to Limit the Innate Immune Response in Acute Respiratory Distress Syndrome
Official Title Innate Immunity in Acute Respiratory Distress Syndrome: A Translational Approach to Limit Inflammasome-dependent Lung Inflammation by Tetracycline
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Adult Respiratory Distress Syndrome
  • Pneumonia
  • Sepsis
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 3, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christian Bode, Dr +49228287 ext 14119 christian.bode@ukbonn.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04079426
Other Study ID Numbers BOST-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Christian Bode, University of Bonn
Study Sponsor University of Bonn
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Bonn
Verification Date September 2019