Application of Clinical Metagenomics in the Diagnosis of Ascites

Ascites Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131751
• Other study ID #: 246/19
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Ascites Infection
• Infections

Intervention

Diagnostic Test:
• Next generation sequencing
we will investigate the sensitivity and specificity of next generation sequencing as a diagnostic tool in ascites infections.

Locations

Country	Name	City	State
Germany	Institute for Microbiology and Hygiene	Freiburg	Baden Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The comparative assessment of about 50 patients		12-18 Months