NCT02912520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

September 13, 2016

Last Update Submit

April 23, 2017

Conditions

Immunoglobulin A

Outcome Measures

Primary Outcomes (1)

  • IgA levels in the bronchoalveolar lavage fluid

    2 weeks of ICU stay

Secondary Outcomes (1)

  • number of detected bacterial, viral, and fungal infections per patient

    through study completion, an average of 2 months

Study Arms (2)

Patients with antibiotic therapy

Patients with antibiotic therapy for 2 weeks.

Drug: Anti-Bacterial Agents

Patients without antibiotic therapy

Patients without any antibiotic therapy in the last 3 months.

Interventions

Anti-Bacterial AgentsDRUG

administration of any antibiotic substance(s) over the course of 2 weeks

Patients with antibiotic therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive inclusion of eligible patients admitted to the ICU.

You may qualify if:

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

You may not qualify if:

  • active infection
  • pregnancy
  • immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Hoogkamp-Korstanje JA, de Koning J, Heesemann J, Festen JJ, Houtman PM, van Oyen PL. Influence of antibiotics on IgA and IgG response and persistence of Yersinia enterocolitica in patients with Yersinia-associated spondylarthropathy. Infection. 1992 Mar-Apr;20(2):53-7. doi: 10.1007/BF01711062.

    PMID: 1582684BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

bronchoalveolar lavage fluid of patients with and without antibiotic therapy.

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Oliver Robak, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 23, 2016

Study Start

June 1, 2016

Primary Completion

April 23, 2017

Study Completion

April 23, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)