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Comparison of IgA Levels in the Bronchoalveolar Lavage Fluid of Patients With and Without Antibiotic Therapy

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ClinicalTrials.gov Identifier: NCT02912520
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Oliver Robak, Medical University of Vienna

Brief Summary:
Investigators hypothesize that Immunoglobine (Ig) production is influenced by the microbiota of the gut. Investigators will compare microbiota-dependent Ig production in the bronchoalveolar lavage fluid of patients with and without antibiotic therapy in order to detect significant differences.

Condition or disease Intervention/treatment
Immunoglobulin A Drug: Anti-Bacterial Agents

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of IgA Levels in the Bronchoalveolar Lavage Fluid of Patients With and Without Antibiotic Therapy
Study Start Date : June 2016
Actual Primary Completion Date : April 23, 2017
Actual Study Completion Date : April 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Patients with antibiotic therapy
Patients with antibiotic therapy for 2 weeks.
Drug: Anti-Bacterial Agents
administration of any antibiotic substance(s) over the course of 2 weeks

Patients without antibiotic therapy
Patients without any antibiotic therapy in the last 3 months.



Primary Outcome Measures :
  1. IgA levels in the bronchoalveolar lavage fluid [ Time Frame: 2 weeks of ICU stay ]

Secondary Outcome Measures :
  1. number of detected bacterial, viral, and fungal infections per patient [ Time Frame: through study completion, an average of 2 months ]

Biospecimen Retention:   Samples Without DNA
bronchoalveolar lavage fluid of patients with and without antibiotic therapy.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive inclusion of eligible patients admitted to the ICU.
Criteria

Inclusion Criteria:

  • endotracheal intubation
  • antibiotic therapy for 2 weeks OR no antibiotic therapy for at least 3 months

Exclusion Criteria:

  • active infection
  • pregnancy
  • immunodeficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912520


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Oliver Robak, MD Medical University of Vienna

Publications:
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Responsible Party: Oliver Robak, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02912520     History of Changes
Other Study ID Numbers: ORV001
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents