NCT04915573

Brief Summary

Cirrhotic patients are more vulnerable to bacterial infection, and infection is one of the most common causes of acute liver disease decompensation.

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 Jun 2021

Shorter than P25 for all trials

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

May 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

May 29, 2021

Last Update Submit

June 9, 2021

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (2)

  • Isolate Identification

    Distribution of bacterial isolates from sputum of cirrhotic patients expressed by frequency of each isolate

    One day

  • Antimicrobial resistance

    Antimicrobial susceptibility testing to antibiotics determined by kirby-bauer disk diffusion

    One day

Study Arms (1)

patients with Cirrhosis

Patient with clinical evidence of liver disease, portal hypertension, ultrasound or computed tomography results, laboratory data will be used to confirm liver disease

Diagnostic Test: Specimen

Interventions

SpecimenDIAGNOSTIC_TEST

Sputum will be collected in clean disposable containers

patients with Cirrhosis

Eligibility Criteria

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

Patients with cirrhosis

You may qualify if:

  • \. Adults' older than 18 years with clinical evidence of liver disease

You may not qualify if:

  • Pregnancy
  • Intensive care unite stay of more than 24 hours
  • Malignancy
  • Organ transplantation
  • Acquired immune deficiency syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

sputum samples

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Noha Mansour, Ph.D

    Mansoura University

    STUDY DIRECTOR

Central Study Contacts

Noha Mansour, Ph.D

CONTACT

0020403315352dr.nohamansour@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 29, 2021

First Posted

June 7, 2021

Study Start

June 7, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

EG(1)