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

April 23, 2017 updated by: Oliver Robak, Medical University of Vienna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive inclusion of eligible patients admitted to the ICU.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • active infection
  • pregnancy
  • immunodeficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IgA levels in the bronchoalveolar lavage fluid
Time Frame: 2 weeks of ICU stay
2 weeks of ICU stay

Secondary Outcome Measures

Outcome Measure
Time Frame
number of detected bacterial, viral, and fungal infections per patient
Time Frame: through study completion, an average of 2 months
through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Oliver Robak, MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

April 23, 2017

Study Completion (Actual)

April 23, 2017

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 23, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORV001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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