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CompletedNCT05117073Updated May 12, 2023

Risk Factors of Spontaneous Fungal Peritonitis in Cirrhotic Patients

An observational study in Spontanous Fungal Peritonitis, sponsored by Sohag University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Sex
All
01

Study summary

Spontaneous bacterial peritonitis (SBP) is an infection of the peritoneal cavity with no surgically treatable intra-abdominal source of infection. Spontaneous peritonitis is a potentially fatal complication in patients with advanced liver cirrhosis. It is estimated that 10-20 % of patients with cirrhotic ascites may develop spontaneous peritonitis, which is usually caused by a bacterial infection.

In contrast, spontaneous fungal peritonitis (SFP) is less well-recognized. SFP may be associated with higher mortality rates than SBP but therapeutic approaches are largely undefined. To this end, the epidemiology and outcomes of patients with SFP have only been documented sporadically aimed to evaluate the risk factors for the development of spontaneous fungal peritonitis (SFP), and the prognosis of SFP compared with SBP

Read the detailed description

Cross-sectional study

Studied population \& locality:

Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals during the period from september 2021 to december 2022 will be included in the study.

According to the results of ascitic fluid analysis, we will divide the patients into 2 groups:

Group (1): patients with spontaneous bacterial peritonitis (SBP). Group (2): patients with spontaneous fungal peritonitis (SFP).

Exclusion criteria:

Patients seropositive for human immunodeficiency virus (HIV) and patients undergoing continuous ambulatory peritoneal dialysis were excluded from this study.

Methods:

All included patients will be subjected to:

  1. Detailed history, complete general and systemic examination.
  2. Ascitic fluid analysis
  3. Bacterial and fungal culture from ascitic fluid:
  4. Laboratory investigations:

Fasting blood sugar Liver function tests. CBC.

Ethical considerations:

02

Conditions studied

  • Spontanous Fungal Peritonitis

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Keywords

  • spontanous fungal peritonitis, liver cirrhosis, risk factors
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In context

Peritonitis

185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.

This study's enrollment of 100 is below the median of 127 across 59 observational studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals

Inclusion criteria

Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals during the period from September 2021 to december 2022

Exclusion criteria

Exclusion Criteria:

Patients seropositive for human immunodeficiency virus (HIV) and patients undergoing continuous ambulatory peritoneal dialysis were excluded from this study.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • spontaneous bacterial peritonitis

    cirrhotic patients diagnosed with SBP

    Diagnostic Test: ASCITIC FLUID CULTURE

  • spontaneous fungal peritonitis

    irrhotic patients diagnosed with SFP

    Diagnostic Test: ASCITIC FLUID CULTURE

Interventions

  • Diagnostic testASCITIC FLUID CULTURE

    Ten milliliters of ascitic fluid will be collected at the bedside and inoculated into aerobic and anaerobic blood culture bottles. Bacterial culture will be performed manually using MacConkey and blood agar plate

06

What researchers measure

Primary outcomes

  1. he risk factors for the development of spontaneous fungal peritonitis

    number/percentage

    Time frame: September 2021 to December 2022 will be included in the study.

07

Study locations

1 site
  • Mona Mohammed Abdelrahman
    Sohag, Egypt
08

References and documents

Publications

  • Hwang SY, Yu SJ, Lee JH, Kim JS, Yoon JW, Kim YJ, Yoon JH, Kim EC, Lee HS. Spontaneous fungal peritonitis: a severe complication in patients with advanced liver cirrhosis. Eur J Clin Microbiol Infect Dis. 2014 Feb;33(2):259-64. doi: 10.1007/s10096-013-1953-2. Epub 2013 Sep 2. PubMed 23996048 ↗
  • Bremmer DN, Garavaglia JM, Shields RK. Spontaneous fungal peritonitis: a devastating complication of cirrhosis. Mycoses. 2015 Jul;58(7):387-93. doi: 10.1111/myc.12321. Epub 2015 Apr 7. PubMed 25851525 ↗
  • Shizuma T. Spontaneous bacterial and fungal peritonitis in patients with liver cirrhosis: A literature review. World J Hepatol. 2018 Feb 27;10(2):254-266. doi: 10.4254/wjh.v10.i2.254. PubMed 29527261 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05117073
Lead sponsor
Sohag University
Responsible party
Mona Mohammed Abdelrhman (Principal investigator, Sohag University) — Principal investigator
First posted
Nov 11, 2021
Start date
Sep 1, 2021
Primary completion
Mar 30, 2023
Completion
Apr 29, 2023
Last update
May 12, 2023

Study contacts

Radwa Farag, MD
study chair · Sohag University
osamaa orabi, MD
study chair · Sohag University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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