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

NCT04079426 | Unknown

• 1 other identifier: BOST-002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Adult Respiratory Distress Syndrome; Pneumonia; Sepsis

Keywords

inflammasome; Caspase; NLRP3; Antibiotics; Tetracycline

Outcome Measures

Primary Outcomes (3)

• Cytokine Levels in Serum and bronchoalveolar fluid

  determined by multiplex Assay \[pg/ml\]

  1 week

• Activation Status of immune cells from blood and bronchoalveolar fluid

  incubation of immune cells with tetracycline and Determination of cytokines by multiplex assay \[pg/ml\]

  1 week

• Alarmins in Serum and bronchoalveolar fluid

  Determination by western blot, qPCR or flow cytometry

  1 week

Interventions

Sampling of Blood and bronchoalveolar lavage OTHER

Multiplex assays for pro- and anti-inflammatory markers and incubation of immune cells isolated from serum and bronchoalveolar lavage fluid of patients with ARDS.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, 53127, Germany

RECRUITING

Related Publications (1)

• Peukert K, Fox M, Schulz S, Feuerborn C, Frede S, Putensen C, Wrigge H, Kummerer BM, David S, Seeliger B, Welte T, Latz E, Klinman D, Wilhelm C, Steinhagen F, Bode C. Inhibition of Caspase-1 with Tetracycline Ameliorates Acute Lung Injury. Am J Respir Crit Care Med. 2021 Jul 1;204(1):53-63. doi: 10.1164/rccm.202005-1916OC.

  PMID: 33760701 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pneumonia; Sepsis

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Central Study Contacts

Christian Bode, Dr

CONTACT

+49228287; christian.bode@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: January 4, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)