Spontaneous Bacterial PeritonitisNCT06778616
Frequency and Predictors of Recurrent SBP in Cirrhotic Patients in Al Rajhi University Hospital
An observational study of Spontaneous Bacterial Peritonitis, run by Assiut University at 2 sites in Egypt.
Trial summary
Assess the frequency of recurrent SBP in ascitic cirrhotic patients. Determine the predictive factors of recurrence after the first episode of SBP in ascitic cirrhotic patients Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- How many people
- 101 participants
- Where
- 2 sitesEgypt
- Study dates
- Feb 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any cirrhotic patient above the age of 18 years old of both sexes, having a first episode of SBP will be included in our study.
Who may be able to join
- Any cirrhotic patient above the age of 18 years old of both sexes, having a first episode of SBP will be included in our study.
- The diagnosis of cirrhosis was based on clinical manifestation (ascites, splenomegaly, lower limb edema and/or esophageal varices by upper gastrointestinal endoscopy), laboratory findings and radiological (abdominal ultrasonography), or liver histology.
- The diagnosis of SBP was based on a neutrophil cell count of 250 cell or more per mm3 with or without culture positivity of ascitic fluid, in the absence of hemorrhagic ascites and secondary peritonitis.
Who cannot join
- Any patient with one or more of the following criteria will be excluded:
- Patients with bacterial ascites defined by a positive culture of ascitic fluid associated with a neutrophil cell count less than 250 cell per mm3 in the ascitic fluid.
- Patients presenting with empyema or bacterial peritonitis secondary to an intra-abdominal organ perforation or surgical operation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Assiut Faculty of Medicine
Asyut, Asyut Governorate, 71515
Asmaa M Hassan, Msc, 00201070041233 ext. 002, asmaamoussa299@gamil.com
Marwa A Ahmed, MD, 01004673807 ext. 002, Marwamakhlof088@gmail.com
Assiut University
Asyut, Asyut Governorate, 71515
Marwa A Ahmed, MD
About this study
Official title: Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital
- Assess the frequency of recurrent SBP in ascitic cirrhotic patients.
- Determine the predictive factors of recurrence after the first episode of SBP in ascitic cirrhotic patients
Read the detailed description
Spontaneous bacterial peritonitis (SBP) is a common complication in cirrhotic patients. The prevalence of SBP in hospitalized patients and the mortality rate were reported to be 10%-30% and 30%-50%, respectively.
SBP has been considered a life-threatening infection that requires a prompt diagnosis and treatment.
- Conditions
- Spontaneous Bacterial Peritonitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital.
Determine the frequency of recurrent SBP after its management within one year
Measured: One year
Secondary outcomes (1)
Predictors of recurrent SBP
Determining risk factors of recurrent SBP
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Moussa Hussein Hassan, Assiut University
- Investigators
- Marwa A Ahmed, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778616
- Sponsor's protocol ID
- Recurrence of SBP
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moalla M, Elleuch N, Dahmani W, Hammami A, Ameur WB, Slama AB, Brahem A, Ajmi S, Ksiaa M, Jaziri H, Jmaa A. Predictive factors of recurrence in spontaneous bacterial peritonitis in Tunisian patients with cirrhosis. Future Sci OA. 2023 Apr 17;9(5):FSO857. doi: 10.2144/fsoa-2023-0016. eCollection 2023 Jun.
PubMed 37180608
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital
- ClinicalTrials.gov ID
- NCT06778616
- Acronym / sponsor ID
- Recurrence of SBP
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 16 Jan 2025 (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.
- Assess the frequency of recurrent SBP in ascitic cirrhotic patients.
- Determine the predictive factors of recurrence after the first episode of SBP in ascitic cirrhotic patients
Detailed description
Spontaneous bacterial peritonitis (SBP) is a common complication in cirrhotic patients. The prevalence of SBP in hospitalized patients and the mortality rate were reported to be 10%-30% and 30%-50%, respectively.
SBP has been considered a life-threatening infection that requires a prompt diagnosis and treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any cirrhotic patient above the age of 18 years old of both sexes, having a first episode of SBP will be included in our study.
Key inclusion criteria (3 listed)
- Any cirrhotic patient above the age of 18 years old of both sexes, having a first episode of SBP will be included in our study.
Key exclusion criteria (3 listed)
- Any patient with one or more of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital.
Time frame: One year
Determine the frequency of recurrent SBP after its management within one year
1 secondary outcome
Predictors of recurrent SBP
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background: PubMed 37180608Moalla M, Elleuch N, Dahmani W, Hammami A, Ameur WB, Slama AB, Brahem A, Ajmi S, Ksiaa M, Jaziri H, Jmaa A. Predictive factors of recurrence in spontaneous bacterial peritonitis in Tunisian patients with cirrhosis. Future Sci OA. 2023 Apr 17;9(5):FSO857. doi: 10.2144/fsoa-2023-0016. eCollection 2023 Jun.
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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.
Marwa A Ahmed, MD study director
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Bacterial Peritonitis, run by Assiut University at 2 sites 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 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: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa M Hussein, MSc (00201070041233 ext. 002, asmaamoussa299@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Predictors of Recurrent Spontaneous Bacterial Peritonitis in Cirrhotic Patients in Al Rajhi University Hospital. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778616, which also lists 1 linked publication.
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 16 Jan 2025.