Application of Clinical Metagenomics in the Diagnosis of Ascites

NCT04131751 | Completed

• 1 other identifier: 246/19
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ascites Infection

Keywords

Metagenomics

Outcome Measures

Primary Outcomes (1)

• The comparative assessment of about 50 patients

  12-18 Months

Interventions

Next generation sequencing DIAGNOSTIC_TEST

we will investigate the sensitivity and specificity of next generation sequencing as a diagnostic tool in ascites infections.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include adult consent intensive care patients who undergo parenthesis for diagnostic purposes to exclude ascitic infection, regardless of the clinical picture. The indication for puncture is provided by the attending clinician regardless of the study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

Institute for Microbiology and Hygiene

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial and fungal DNA from human ascites samples.

Study Officials

• Mohamed Tarek Badr, MD

  Institute for Microbiology and Hygiene, Hermann-Herder-Str. 11, 79104 Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: October 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

DE (1)