Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04131751
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2019-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Clinical Metagenomics in the Diagnosis of Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bacterial and fungal DNA from human ascites samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The comparative assessment of about 50 patients', 'timeFrame': '12-18 Months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metagenomics'], 'conditions': ['Ascites Infection']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients ≥ 18 years of age\n* Samples from patients who have ascites puncture to exclude infection\n* Written consent of the patient after clarification\n\nExclusion Criteria:\n\n* Minor patients\n* Non-consenting patients\n* Samples without sufficient residual material after standard diagnostics\n* Samples from patients who have not consented to the examination.'}, 'identificationModule': {'nctId': 'NCT04131751', 'briefTitle': 'Application of Clinical Metagenomics in the Diagnosis of Ascites', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Establishing of Next Genaration Sequencing Methods for Microbiological Diagnostic of Ascitic Fluid Infections', 'orgStudyIdInfo': {'id': '246/19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Next generation sequencing', 'type': 'DIAGNOSTIC_TEST', 'description': 'we will investigate the sensitivity and specificity of next generation sequencing as a diagnostic tool in ascites infections.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79104', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Institute for Microbiology and Hygiene', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Mohamed Tarek Badr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Microbiology and Hygiene, Hermann-Herder-Str. 11, 79104 Freiburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Tarek Badr', 'investigatorAffiliation': 'University Hospital Freiburg'}}}}