NCT04131751

Application of Clinical Metagenomics in the Diagnosis of Ascites

Completed Last updated 1 November 2021

What this trial tests

trial testing Next generation sequencing in Ascites Infection in 50 participants. Completed in 1 October 2021.

Timeline

1 October 2019

Primary endpoint
1 June 2021

1 October 2021

Quick facts

Lead sponsor	University Hospital Freiburg
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	1 October 2019
Primary completion	1 June 2021
Estimated completion	1 October 2021
Sites	1 location across Germany

Drugs / interventions tested

• Next generation sequencing

Conditions studied

• Ascites Infection — all drugs for Ascites Infection →

Sponsor

University Hospital Freiburg

Who can join

18 and older, any sex, with Ascites Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Next- and Third-Generation Sequencing Outperforms Culture-Based Methods in the Diagnosis of Ascitic Fluid Bacterial Infections of ICU Patients.
   Goelz H, Wetzel S, Mehrbarzin N, Utzolino S, et al · · 2021 · cited 23× · PMID 34831447 · DOI 10.3390/cells10113226
2. Enhancing ascitic fungal infection diagnosis through next-generation sequencing: a pilot study in surgical ICU patients.
   Posadas-Cantera S, Mehrbarzin N, Wetzel S, Goelz H, et al · · 2024 · cited 2× · PMID 39554813 · DOI 10.3389/fcimb.2024.1441805