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OpenTrials
Completed

NCT Number: NCT04131751

Application of Clinical Metagenomics in the Diagnosis of Ascites

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Microbiology and Hygiene

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Next generation sequencing

Diagnostic Test

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

Primary outcomes

  1. The comparative assessment of about 50 patients

    Time frame: 12-18 Months

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2019
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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