Immunoglobulin ANCT02912520

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

An observational study of Immunoglobulin A, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Immunoglobulin A
What is being tested?: Anti-Bacterial Agents
How many people: 20 participants
Where: 1 siteAustria
Study dates: Jun 2016to 23 Apr 2017
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: Consecutive inclusion of eligible patients admitted to the ICU.

Who may be able to join

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

Who cannot join

active infection
pregnancy
immunodeficiency

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna, 1090

Other trials in Austria

About this study

Conditions: Immunoglobulin A
Being tested: Anti-Bacterial Agents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anti-Bacterial AgentsDrug
administration of any antibiotic substance(s) over the course of 2 weeks

Study groups in NCT02912520
Study group	Role	What they receive
Patients with antibiotic therapy		Patients with antibiotic therapy for 2 weeks. Receives: Drug: Anti-Bacterial Agents
Patients without antibiotic therapy		Patients without any antibiotic therapy in the last 3 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

IgA levels in the bronchoalveolar lavage fluid
Measured: 2 weeks of ICU stay

Secondary outcomes (1)

number of detected bacterial, viral, and fungal infections per patient
Measured: through study completion, an average of 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201623 Apr 2017

First posted23 Sep 2016 (estimated)
Study startJun 2016
Primary completion23 Apr 2017
Study completion23 Apr 2017

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 Immunoglobulin AStudies of the same condition, open and under way.
More trials run by Medical University of ViennaThe sponsor's other registered studies.
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: Cohort
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02912520
Sponsor's protocol ID: ORV001
Status last verified: Apr 2017
First submitted: 13 Sep 2016
Last updated: 25 Apr 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 1582684

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Immunoglobulin A trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of IgA Levels in the Bronchoalveolar Lavage Fluid of Patients With and Without Antibiotic Therapy
ClinicalTrials.gov ID: NCT02912520
Acronym / sponsor ID: ORV001
Conditions: Immunoglobulin A
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Study start: Jun 2016
Primary completion: 23 Apr 2017 (actual)
Study completion: 23 Apr 2017 (actual)
First posted: 23 Sep 2016 (estimated)
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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Patients with antibiotic therapy	–	Drug: Anti-Bacterial AgentsPatients with antibiotic therapy for 2 weeks.
Patients without antibiotic therapy	–	–Patients without any antibiotic therapy in the last 3 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consecutive inclusion of eligible patients admitted to the ICU.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

active infection
pregnancy
immunodeficiency

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
Anti-Bacterial Agentsadministration of any antibiotic substance(s) over the course of 2 weeks	Drug	Patients with antibiotic therapy

Primary outcome

IgA levels in the bronchoalveolar lavage fluid
Time frame: 2 weeks of ICU stay

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
Background: PubMed 1582684Hoogkamp-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.
Individual participant dataSharing planned: No

Related trials for Immunoglobulin A

Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
Zanubritnib and Anti-MAG Neuropathy
Anti-MAG IgM-associated Demyelinating Polyneuropathy

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.

Oliver Robak, MD principal investigator

Medical University of Vienna

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 Immunoglobulin A, run by Medical University of Vienna at 1 site in Austria.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Apr 2017. 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 Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IgA levels in the bronchoalveolar lavage fluid (time frame: 2 weeks of ICU stay). 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 NCT02912520, 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 25 Apr 2017.