NCT04216745

Brief Summary

  • To identify the microbial profile in bile and blood for patients with cholangitis.
  • To explore risk factors of cholangitis and outcomes in those patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

December 27, 2019

Last Update Submit

January 12, 2021

Conditions

Cholangitis

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the microbial profile of cholangitis

    to evaluate the microbial profile of cholangitis regarding types of organisms

    Up to 24 weeks

Secondary Outcomes (1)

  • Evaluation of short-term mortality

    Up to 24 weeks

Interventions

bile cultureDIAGNOSTIC_TEST

Bile samples will be collected for microbial cultures and antimicrobial susceptibility testing using COMPACT-15 automated system (Bio Merieux, Marcy I'Etoile, France) for bacteria and saboroud's agar for fungal culture.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\- Patients with extrahepatic cholestasis undergoing biliary procedure (ERCP or PTD)

You may qualify if:

  • Patients with extrahepatic cholestasis undergoing biliary procedure (ERCP or PTD) will be included.

You may not qualify if:

  • patients less than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Abeer Sharaf, AP

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Nourhan Mostafa

CONTACT

01001668484nourhanmostafa314@gmail.com

Elham Ahmed, AP

CONTACT

01002963415mam_elham75@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 3, 2020

Study Start

March 1, 2020

Primary Completion

March 30, 2021

Study Completion

May 30, 2021

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations

EG(1)