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

NCT ID: NCT04079426

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-04

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adult Respiratory Distress Syndrome Pneumonia Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bonn

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Christian Bode

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Bonn

Bonn, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christian Bode, Dr

Role: CONTACT

+49228287 ext. 14119

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chrisitan Bode, MD

Role: primary

+4922828714119

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33760701 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BOST-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Thyroid and Adrenal Disorders in ICU
NCT07245550 NOT_YET_RECRUITING