Application of Clinical Metagenomics in the Diagnosis of Ascites

Sponsor

University Hospital Freiburg (Other)

Overall Status

Completed

CT.gov ID

NCT04131751

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Infection of the ascitic fluid is a serious complication associated with high morbidity and mortality. This fluid is often colonized with bacteria that can cause infection of the peritoneum and possibly sepsis. Many bacteria of the human intestinal microbiome can't be cultured by standard methods; therefore it seems likely that many of the relevant bacteria are not discovered in routine diagnostics, but may be relevant to pathogenesis. Culture-independent approaches such as NGS (Next generation Sequencing) have in principle made it possible to study or prove complex microbial colonization. Because NGS is a relatively new technology, microbiological diagnostic protocols need to be further customized and refined to integrate with the standard diagnostic workflow, if necessary. For microbiological diagnostics, material is collected from the appropriate ascites patients and sent for microbiological diagnostics. Afterwards the cultural diagnostics are carried out as part of the patient care at the university hospital. In this study the investigators plan to use these samples to analyze and compare the presence of bacteria by NGS in parallel to the culture diagnostics, and then compare it to the patients' gut microbiome, to understand the possible effect of the microbiome on ascites pathogenesis and outcome.

Condition or Disease	Intervention/Treatment	Phase
Ascites Infection	Diagnostic Test: Next generation sequencing

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Establishing of Next Genaration Sequencing Methods for Microbiological Diagnostic of Ascitic Fluid Infections

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Outcome Measures

Primary Outcome Measures

The comparative assessment of about 50 patients [12-18 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female patients ≥ 18 years of age
Samples from patients who have ascites puncture to exclude infection
Written consent of the patient after clarification

Exclusion Criteria:

Minor patients
Non-consenting patients
Samples without sufficient residual material after standard diagnostics
Samples from patients who have not consented to the examination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Microbiology and Hygiene	Freiburg	Baden Württemberg	Germany	79104

Sponsors and Collaborators

University Hospital Freiburg

Investigators

Principal Investigator: Mohamed Tarek Badr, MD, Institute for Microbiology and Hygiene, Hermann-Herder-Str. 11, 79104 Freiburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Tarek Badr, Principal Investigator, University Hospital Freiburg

ClinicalTrials.gov Identifier:

NCT04131751

Other Study ID Numbers:

246/19

First Posted:

Oct 18, 2019

Last Update Posted:

Nov 1, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Tarek Badr, Principal Investigator, University Hospital Freiburg

Metagenomics

Additional relevant MeSH terms:

Infections

Ascites

Study Results

No Results Posted as of Nov 1, 2021