Spontaneous Bacterial PeritonitisMaSS/SBPNCT07024355
Predicting and Monitoring Spontaneous Bacterial Peritonitis in Cirrhotic Patients Using the Mansoura Scoring System
An observational study of Spontaneous Bacterial Peritonitis, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this prospective study was to examine predictors of SBP in order to develop a noninvasive method to identify or exclude an episode of SBP, for starting early treatment with antibiotics, so decrease morbidity and mortality in these patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Aug 2026
- 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: This prospective study included all adult patients with cirrhosis and ascites admitted to AL-Rajhy Liver Hospital between April 2025 and April 2027
Who may be able to join
- Adult patients aged >18 years
- Diagnosed liver cirrhosis
- Presence of ascites
- Provided written informed consent
Who cannot join
- Use of antibiotics within the previous two weeks
- Prophylactic treatment for spontaneous bacterial peritonitis (SBP) prior to admission
- Ascites not related to portal hypertension, including:
- Peritoneal tuberculosis
- Peritoneal carcinomatosis
- Congestive heart failure
Show all 23Show fewer
- Renal disease
- Pancreatitis
- Hemorrhagic ascites
- Secondary peritonitis
- Presence of infections other than SBP, including:
- Pneumonia
- Urinary tract infection
- Skin and soft tissue infection
- Presence of malignancy Hematologic diseases
- Use of antiplatelet drugs or non-steroidal anti-inflammatory drugs (NSAIDs)
- Receipt of platelet or blood transfusion prior to admission
- Diseases associated with elevated mean platelet volume (MPV), including:
- Diabetes mellitus
- Cardiovascular disease
- Hyperthyroidism
- Immune thrombocytopenia
- Myeloproliferative disorders
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective study was to examine predictors of SBP in order to develop a noninvasive method to identify or exclude an episode of SBP, for starting early treatment with antibiotics, so decrease morbidity and mortality in these patients.
Read the detailed description
Spontaneous bacterial peritonitis (SBP) is a bacterial infection of ascitic fluid without any intra-abdominal, surgically treatable cause.
SBP is the most common bacterial infection in patients with cirrhosis, with a mortality rate exceeding 90% in untreated cases. However, inpatient mortality has been reduced to about 20% with early diagnosis and effective treatment.
Delayed diagnosis increases in-hospital mortality; with each hour of delay in performing paracentesis for SBP diagnosis, mortality increases by approximately 3.3%.
A study conducted in the United States reported that paracentesis was performed within the first 24 hours of admission in only 66% of cirrhotic patients with ascites.
Another study noted that routine paracentesis cannot be performed in all patients with liver cirrhosis. Therefore, delaying diagnosis increases mortality, and it is necessary to find a non-invasive and accurate method for predicting SBP.
Important risk factors for the development of SBP in cirrhotic patients include a history of SBP, variceal hemorrhage, and the use of proton pump inhibitors Several laboratory parameters have been evaluated as early predictors of SBP, including C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), mean platelet volume (MPV), platelet count, and serum creatinine level. However, the data remain inconsistent.
Recently, the Mansoura Scoring System was developed at Mansoura University and retrospectively applied to cirrhotic patients with ascites for early SBP diagnosis without waiting for peritoneal fluid analysis.
The Mansoura score includes four components: age, MPV, and NLR (1 point each), and CRP (2 points), yielding a total score of 0 to 5. SBP is diagnosed when the score is equal to or greater than 4.
- Conditions
- Spontaneous Bacterial Peritonitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the Mansoura Scoring System for Predicting Spontaneous Bacterial Peritonitis (SBP)
Primary Outcome Measure Title:Diagnostic Accuracy of the Mansoura Scoring System for Predicting Spontaneous Bacterial Peritonitis (SBP) Description: Evaluation of the diagnostic performance of the Mansoura scoring system in predicting spontaneous bacterial peritonitis (SBP), using ascitic fluid neutrophil count >250 cells/mm³ as the reference standard. Diagnostic accuracy will be assessed in terms of sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve.
Unit of Measure: Percentage / AUC
Measured: At hospital admission ( within 24 hours of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
- Investigators
- Amira M Abdelmawgod, Lecturer, Trop Med, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024355
- Sponsor's protocol ID
- 04-2025-300593
- Acronym
- MaSS/SBP
- Status last verified
- Jun 2025
- First submitted
- 23 Apr 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting and Monitoring Spontaneous Bacterial Peritonitis in Cirrhotic Patients Using the Mansoura Scoring System
- ClinicalTrials.gov ID
- NCT07024355
- Acronym / sponsor ID
- MaSS/SBP / 04-2025-300593
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 17 Jun 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.
The aim of this prospective study was to examine predictors of SBP in order to develop a noninvasive method to identify or exclude an episode of SBP, for starting early treatment with antibiotics, so decrease morbidity and mortality in these patients.
Detailed description
Spontaneous bacterial peritonitis (SBP) is a bacterial infection of ascitic fluid without any intra-abdominal, surgically treatable cause.
SBP is the most common bacterial infection in patients with cirrhosis, with a mortality rate exceeding 90% in untreated cases. However, inpatient mortality has been reduced to about 20% with early diagnosis and effective treatment.
Delayed diagnosis increases in-hospital mortality; with each hour of delay in performing paracentesis for SBP diagnosis, mortality increases by approximately 3.3%.
A study conducted in the United States reported that paracentesis was performed within the first 24 hours of admission in only 66% of cirrhotic patients with ascites.
Another study noted that routine paracentesis cannot be performed in all patients with liver cirrhosis. Therefore, delaying diagnosis increases mortality, and it is necessary to find a non-invasive and accurate method for predicting SBP.
Important risk factors for the development of SBP in cirrhotic patients include a history of SBP, variceal hemorrhage, and the use of proton pump inhibitors Several laboratory parameters have been evaluated as early predictors of SBP, including C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), mean platelet volume (MPV), platelet count, and serum creatinine level. However, the data remain inconsistent.
Recently, the Mansoura Scoring System was developed at Mansoura University and retrospectively applied to cirrhotic patients with ascites for early SBP diagnosis without waiting for peritoneal fluid analysis.
The Mansoura score includes four components: age, MPV, and NLR (1 point each), and CRP (2 points), yielding a total score of 0 to 5. SBP is diagnosed when the score is equal to or greater than 4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This prospective study included all adult patients with cirrhosis and ascites admitted to AL-Rajhy Liver Hospital between April 2025 and April 2027
Key inclusion criteria (4 listed)
- Adult patients aged >18 years
- Diagnosed liver cirrhosis
- Presence of ascites
- Provided written informed consent
Key exclusion criteria (23 listed)
- Use of antibiotics within the previous two weeks
- Prophylactic treatment for spontaneous bacterial peritonitis (SBP) prior to admission
- Ascites not related to portal hypertension, including:
- Peritoneal tuberculosis
- Peritoneal carcinomatosis
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
Diagnostic Accuracy of the Mansoura Scoring System for Predicting Spontaneous Bacterial Peritonitis (SBP)
Time frame: At hospital admission ( within 24 hours of admission)
Primary Outcome Measure Title:Diagnostic Accuracy of the Mansoura Scoring System for Predicting Spontaneous Bacterial Peritonitis (SBP) Description: Evaluation of the diagnostic performance of the Mansoura scoring system in predicting spontaneous bacterial peritonitis (SBP), using ascitic fluid neutrophil count >250 cells/mm³ as the reference standard. Diagnostic accuracy will be assessed in terms of sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve. Unit of Measure: Percentage / AUC
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 5 Nov 2026.
Related trials for Spontaneous Bacterial Peritonitis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
Not yet recruitingPhase 4
Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence
Cirrhosis With Spontaneous Bacterial Peritonitis
Not yet recruitingObservational study
Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.
Spontaneous Bacterial Peritonitis
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.
Amira M Abdelmawgod, Lecturer, Trop Med principal investigator
Assiut 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 Spontaneous Bacterial Peritonitis, run by Assiut 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 4 inclusion and 23 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 5 Nov 2026. 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?
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?
Diagnostic Accuracy of the Mansoura Scoring System for Predicting Spontaneous Bacterial Peritonitis (SBP) (time frame: At hospital admission ( within 24 hours of admission)). 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 5 Nov 2026.