NCT07024355

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

April 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

January 22, 2026

Status Verified

June 1, 2025

Enrollment Period

Same day

First QC Date

April 23, 2025

Last Update Submit

January 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    At hospital admission ( within 24 hours of admission)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Adult patients aged \>18 years
  • Diagnosed liver cirrhosis
  • Presence of ascites
  • Provided written informed consent

You may not qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Amira M Abdelmawgod, Lecturer, Trop Med

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira M Abdelmawgod, Lecturer, Trop Med

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 23, 2025

First Posted

June 17, 2025

Study Start

April 1, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

January 22, 2026

Record last verified: 2025-06