CirrhosisNCT04915573
Antimicrobial Resistance in Cirrhotic Patients
An observational study of Cirrhosis, run by Mansoura University at 1 site in Egypt.
Trial summary
Cirrhotic patients are more vulnerable to bacterial infection, and infection is one of the most common causes of acute liver disease decompensation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Specimen
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jun 2021to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with cirrhosis
Who may be able to join
- 1. Adults' older than 18 years with clinical evidence of liver disease
Who cannot join
- Pregnancy
- Intensive care unite stay of more than 24 hours
- Malignancy
- Organ transplantation
- Acquired immune deficiency syndrome
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta
Rehab Badawi, PhD
About this study
Official title: Antimicrobial Resistance Among Sputum Pathogens in Post Hepatitis Cirrhotic Patients
Cirrhotic patients are more vulnerable to bacterial infection, and infection is one of the most common causes of acute liver disease decompensation.
Read the detailed description
Cirrhotic patients are more vulnerable to bacterial infection which is a common cause of acute liver disease decompensation. The aim of this study will characterize the antimicrobial resistance and distribution of bacteria isolated from chronic hepatic patients with pulmonary infections, as well as to evaluate the antimicrobial susceptibility of bacteria isolated from sputum.
- Conditions
- Cirrhosis
- Being tested
- Specimen
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpecimenDiagnostic test
Sputum will be collected in clean disposable containers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolate Identification
Distribution of bacterial isolates from sputum of cirrhotic patients expressed by frequency of each isolate
Measured: One day
Antimicrobial resistance
Antimicrobial susceptibility testing to antibiotics determined by kirby-bauer disk diffusion
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start7 Jun 2021
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
- Investigators
- Noha Mansour, Ph.D, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915573
- Sponsor's protocol ID
- 34647/4/21
- Status last verified
- Jun 2021
- First submitted
- 29 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Resistance Among Sputum Pathogens in Post Hepatitis Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04915573
- Acronym / sponsor ID
- 34647/4/21
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cirrhotic patients are more vulnerable to bacterial infection, and infection is one of the most common causes of acute liver disease decompensation.
Detailed description
Cirrhotic patients are more vulnerable to bacterial infection which is a common cause of acute liver disease decompensation. The aim of this study will characterize the antimicrobial resistance and distribution of bacteria isolated from chronic hepatic patients with pulmonary infections, as well as to evaluate the antimicrobial susceptibility of bacteria isolated from sputum.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Cirrhosis | – | Diagnostic Test: SpecimenPatient with clinical evidence of liver disease, portal hypertension, ultrasound or computed tomography results, laboratory data will be used to confirm liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis
Key inclusion criteria (1 listed)
- 1. Adults' older than 18 years with clinical evidence of liver disease
Key exclusion criteria (5 listed)
- Pregnancy
- Intensive care unite stay of more than 24 hours
- Malignancy
- Organ transplantation
- Acquired immune deficiency syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpecimenSputum will be collected in clean disposable containers | Diagnostic test | patients with Cirrhosis |
Primary outcome
Isolate Identification
Time frame: One day
Distribution of bacterial isolates from sputum of cirrhotic patients expressed by frequency of each isolate
Antimicrobial resistance
Time frame: One day
Antimicrobial susceptibility testing to antibiotics determined by kirby-bauer disk diffusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha Mansour, Ph.D study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha Mansour, Ph.D (0020403315352, dr.nohamansour@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolate Identification (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.