Transplantation InfectionNCT02777632
Resistant Bacterial Infections in the Early Post LDLT Period
An observational study of Transplantation Infection, run by Ain Shams University.
Trial summary
The purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation. Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Transplantation Infection
- What is being tested?
- Living donor liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 2015
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: HCV patients who underwent living donor liver transplantation at Ain Shams Center for Organ Transplantation.
Who may be able to join
- Egyptian nationality.
- Accepting participation in the current study and signing a written consent form
- Age between 18-60 Years, including males and females.
Who cannot join
- Patients who refused to be enrolled in the study.
- Patients with other etiologies for end-stage liver disease (HBV, PBC…)
- Patients with preoperative infections, infections within 48 h after transplantation or early post-operative death
About this study
The purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation. Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy
Read the detailed description
This prospective descriptive study has been done at Tropical Medicine department in the period between January 2014 to November 2015.
After the approval of the scientific and ethical committee of Ain Shams University Hospital, Patients with HCV positive end stage liver disease (ESLD) eligible for liver transplantation Ain Shams Center for Organ Transplant (ASCOT); Ain Shams University, (fulfilling the inclusion criteria) were included in the current study. Forty five patients were recruited and each one was followed-up during a period of 3 months following transplantation.
Included patients were divided into 2 groups:
Group 1 included patients who had a postoperative single episode of infection. Group 2 included those patients who had more than 1 episode of postoperative bacterial infection whom were further evaluated for the presence of emerging strains and/or antibiotic resistance.
- Conditions
- Transplantation Infection
- Being tested
- Living donor liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living donor liver transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HCV patients following living donor liver transplantation | single infection episode group Receives: Procedure: Living donor liver transplantation | |
| patients following living donor liver transplantation | recurrent Infections episode group Receives: Procedure: Living donor liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the types of early bacterial infections following LDLT, recurrent and resistant infections all were confirmed by cultures.
Bile, abdominal drains, blood stream infection, urinary tract infection or chest infection.
Measured: Within the first 90 days after the operation
Assessment of risk factors for occurrence of recurrent bacterial infections
Independent risk factors for infections
Measured: The first 3 months following LDLT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Mahmoud Aly Massoud, Ain Shams University
- Investigators
- Yasmine M Massoud, MD, Principal investigator, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777632
- Sponsor's protocol ID
- 2652010
- Status last verified
- Feb 2017
- First submitted
- 17 May 2016
- Last updated
- 6 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Bacterial Infections in the Early Post LDLT Period
- ClinicalTrials.gov ID
- NCT02777632
- Acronym / sponsor ID
- 2652010
- Conditions
- Transplantation Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 May 2016 (estimated)
- 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.
The purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation. Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy
Detailed description
This prospective descriptive study has been done at Tropical Medicine department in the period between January 2014 to November 2015.
After the approval of the scientific and ethical committee of Ain Shams University Hospital, Patients with HCV positive end stage liver disease (ESLD) eligible for liver transplantation Ain Shams Center for Organ Transplant (ASCOT); Ain Shams University, (fulfilling the inclusion criteria) were included in the current study. Forty five patients were recruited and each one was followed-up during a period of 3 months following transplantation.
Included patients were divided into 2 groups:
Group 1 included patients who had a postoperative single episode of infection. Group 2 included those patients who had more than 1 episode of postoperative bacterial infection whom were further evaluated for the presence of emerging strains and/or antibiotic resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV patients following living donor liver transplantation | – | Procedure: Living donor liver transplantationsingle infection episode group |
| patients following living donor liver transplantation | – | Procedure: Living donor liver transplantationrecurrent Infections episode group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- HCV patients who underwent living donor liver transplantation at Ain Shams Center for Organ Transplantation.
Key inclusion criteria (3 listed)
- Egyptian nationality.
- Accepting participation in the current study and signing a written consent form
- Age between 18-60 Years, including males and females.
Key exclusion criteria (3 listed)
- Patients who refused to be enrolled in the study.
- Patients with other etiologies for end-stage liver disease (HBV, PBC…)
- Patients with preoperative infections, infections within 48 h after transplantation or early post-operative death
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 |
|---|---|---|
| Living donor liver transplantation | Procedure or surgery | HCV patients following living donor liver transplantation, patients following living donor liver transplantation |
Primary outcome
Determine the types of early bacterial infections following LDLT, recurrent and resistant infections all were confirmed by cultures.
Time frame: Within the first 90 days after the operation
Bile, abdominal drains, blood stream infection, urinary tract infection or chest infection.
Assessment of risk factors for occurrence of recurrent bacterial infections
Time frame: The first 3 months following LDLT
Independent risk factors for infections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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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.
Yasmine M Massoud, MD principal investigator
Faculty of Medicine, Ain Shams University
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation Infection, run by Ain Shams University.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the types of early bacterial infections following LDLT, recurrent and resistant infections all were confirmed by cultures. (time frame: Within the first 90 days after the operation). 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 6 Feb 2017.