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

Sepsis Clinical Trial

Official title:

Innate Immunity in Acute Respiratory Distress Syndrome: A Translational Approach to Limit Inflammasome-dependent Lung Inflammation by Tetracycline

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04079426
• Other study ID #: BOST-002
• Status: Recruiting
• Start date: January 4, 2019
• Est. completion date: January 2022

Study information

• Verified date: September 2019
• Source: University of Bonn
• Contact: Christian Bode, Dr
• Phone: +49228287
• Email: christian.bode[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Adult Respiratory Distress Syndrome
• Pneumonia
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Syndrome

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.

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine Levels in Serum and bronchoalveolar fluid	determined by multiplex Assay [pg/ml]	1 week
Primary	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
Primary	Alarmins in Serum and bronchoalveolar fluid	Determination by western blot, qPCR or flow cytometry	1 week