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

• Conditions: Sepsis; Adult Respiratory Distress Syndrome; Pneumonia

• Registration Number: NCT04079426
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-04
• Study First Submitted: 2019-08-29
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-03
• Last Update Submitted: 2019-09-03
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Activation Status of immune cells from blood and bronchoalveolar fluid	1 week	incubation of immune cells with tetracycline and Determination of cytokines by multiplex assay \[pg/ml\]
Alarmins in Serum and bronchoalveolar fluid	1 week	Determination by western blot, qPCR or flow cytometry
Cytokine Levels in Serum and bronchoalveolar fluid	1 week	determined by multiplex Assay \[pg/ml\]

Trial Locations

Locations (1)

University Hospital Bonn; 🇩🇪 Bonn, Germany