Adult Respiratory Distress SyndromeNCT04079426
Tetracycline to Limit the Innate Immune Response in Acute Respiratory Distress Syndrome
An observational study of Adult Respiratory Distress Syndrome and Pneumonia, run by University of Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Respiratory Distress Syndrome, Pneumonia, Sepsis
- What is being tested?
- Sampling of Blood and bronchoalveolar lavage
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jan 2019to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants admitted to the Intensive Care Unit of the University Hospital of Bonn with an initial diagnosis of ARDS
Who may be able to join
- Age > 18 years
- Informed consent of the patient
- Diagnosis of ARDS for < 48 h
Who cannot join
- Age < 18 years
- Missing informed consent
- Immune therapy
- Autoimmune disease
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn, 53127
Chrisitan Bode, MD, +4922828714119, christian.bode@ukb.uni-bonn.de
About this study
Official title: Innate Immunity in Acute Respiratory Distress Syndrome: A Translational Approach to Limit Inflammasome-dependent Lung Inflammation by Tetracycline
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
- Being tested
- Sampling of Blood and bronchoalveolar lavage
- Keywords
- inflammasome, Caspase, NLRP3, Antibiotics, Tetracycline
- Medical subject headings
- Respiratory Distress Syndrome, Pneumonia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of Blood and bronchoalveolar lavageOther
Multiplex assays for pro- and anti-inflammatory markers and incubation of immune cells isolated from serum and bronchoalveolar lavage fluid of patients with ARDS.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine Levels in Serum and bronchoalveolar fluid
determined by multiplex Assay [pg/ml]
Measured: 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]
Measured: 1 week
Alarmins in Serum and bronchoalveolar fluid
Determination by western blot, qPCR or flow cytometry
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start4 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Bode, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079426
- Sponsor's protocol ID
- BOST-002
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33760701
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immunity in Acute Respiratory Distress Syndrome: A Translational Approach to Limit Inflammasome-dependent Lung Inflammation by Tetracycline
- ClinicalTrials.gov ID
- NCT04079426
- Acronym / sponsor ID
- BOST-002
- Conditions
- Adult Respiratory Distress Syndrome, Pneumonia, Sepsis
- Keywords
- inflammasome, Caspase, NLRP3, Antibiotics, Tetracycline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants admitted to the Intensive Care Unit of the University Hospital of Bonn with an initial diagnosis of ARDS
Key inclusion criteria (3 listed)
- Age > 18 years
- Informed consent of the patient
- Diagnosis of ARDS for < 48 h
Key exclusion criteria (4 listed)
- Age < 18 years
- Missing informed consent
- Immune therapy
- Autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of Blood and bronchoalveolar lavageMultiplex assays for pro- and anti-inflammatory markers and incubation of immune cells isolated from serum and bronchoalveolar lavage fluid of patients with ARDS. | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 33760701Peukert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Respiratory Distress Syndrome and Pneumonia, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Bode, Dr (+49228287 ext. 14119, christian.bode@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine Levels in Serum and bronchoalveolar fluid (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04079426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.