Spontanous Fungal PeritonitisNCT05117073
Risk Factors of Spontaneous Fungal Peritonitis in Cirrhotic Patients
An observational study of Spontanous Fungal Peritonitis, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spontanous Fungal Peritonitis
- What is being tested?
- ASCITIC FLUID CULTURE
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 29 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients seropositive for human immunodeficiency virus (HIV) and patients undergoing continuous ambulatory peritoneal dialysis were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Detailed history, complete general and systemic examination.
- Ascitic fluid analysis
- Bacterial and fungal culture from ascitic fluid:
- Laboratory investigations:
Fasting blood sugar Liver function tests. CBC.
Ethical considerations:
- Conditions
- Spontanous Fungal Peritonitis
- Being tested
- ASCITIC FLUID CULTURE
- Keywords
- spontanous fungal peritonitis, liver cirrhosis, risk factors
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASCITIC FLUID CULTUREDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| spontaneous bacterial peritonitis | cirrhotic patients diagnosed with SBP Receives: Diagnostic Test: ASCITIC FLUID CULTURE | |
| spontaneous fungal peritonitis | irrhotic patients diagnosed with SFP Receives: Diagnostic Test: ASCITIC FLUID CULTURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
he risk factors for the development of spontaneous fungal peritonitis
number/percentage
Measured: September 2021 to December 2022 will be included in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Sep 2021
- Primary completion30 Mar 2023
- Study completion29 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spontanous Fungal PeritonitisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohammed Abdelrhman, Sohag University
- Investigators
- Radwa Farag, MD, Study chair, Sohag Universityosamaa orabi, MD, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117073
- Sponsor's protocol ID
- Soh-Med-21-10-53
- Status last verified
- May 2023
- First submitted
- 1 Nov 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23996048Bremmer 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 25851525Shizuma 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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Spontaneous Fungal Peritonitis in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT05117073
- Acronym / sponsor ID
- Soh-Med-21-10-53
- Conditions
- Spontanous Fungal Peritonitis
- Keywords
- spontanous fungal peritonitis, liver cirrhosis, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 29 Apr 2023 (actual)
- First posted
- 11 Nov 2021 (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.
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
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:
- Detailed history, complete general and systemic examination.
- Ascitic fluid analysis
- Bacterial and fungal culture from ascitic fluid:
- Laboratory investigations:
Fasting blood sugar Liver function tests. CBC.
Ethical considerations:
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spontaneous bacterial peritonitis | – | Diagnostic Test: ASCITIC FLUID CULTUREcirrhotic patients diagnosed with SBP |
| spontaneous fungal peritonitis | – | Diagnostic Test: ASCITIC FLUID CULTUREirrhotic patients diagnosed with SFP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients seropositive for human immunodeficiency virus (HIV) and patients undergoing continuous ambulatory peritoneal dialysis were excluded from this study.
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 |
|---|---|---|
| ASCITIC FLUID CULTURETen 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 | Diagnostic test | spontaneous bacterial peritonitis, spontaneous fungal peritonitis |
Primary outcome
he risk factors for the development of spontaneous fungal peritonitis
Time frame: September 2021 to December 2022 will be included in the study.
number/percentage
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 12 May 2023.
- Background: PubMed 23996048Hwang 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.
- Background: PubMed 25851525Bremmer 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.
- Background: PubMed 29527261Shizuma 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.
- Individual participant dataSharing planned: No
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.
Radwa Farag, MD study chair
Sohag University
osamaa orabi, MD study chair
Sohag 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 Spontanous Fungal Peritonitis, run by Sohag 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 1 inclusion and 1 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 12 May 2023. 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?
he risk factors for the development of spontaneous fungal peritonitis (time frame: September 2021 to December 2022 will be included in the study.). 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 NCT05117073, which also lists 3 linked publications.
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 12 May 2023.