Spontaneous Bacterial PeritonitisNCT02759497
Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis
An observational study of Spontaneous Bacterial Peritonitis, run by Tanta University at 1 site in Egypt.
Trial summary
One of the most common and serious complications in decompensated cirrhotic patients (DCPs) is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections, pneumonia and cellulitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- serum amyloid A level
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Nov 2020
- 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: Decompensated cirrhosis with SBP Decompensated cirrhosis without SBP
Who may be able to join
- • Decompansated cirrhosis with ascites, defined by a combination of any of the following:
- Laboratory findings
- Endoscopic results
- Ultrasound
- Histology
Who cannot join
- Creatinine>1.5 mg/dl
- Other infection e.grespiratory,UTI ,gastrointestinal and skin infection.
- Hepatocellular carcinoma
- Other extrahepatic malignancy e.g ; chest
- Any significant psychiatric illness or other medical comorbidity.
- Any degenerative diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Cairo
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
One of the most common and serious complications in decompensated cirrhotic patients (DCPs) is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections, pneumonia and cellulitis.
Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and macrophages can also produce these proteins. The induction of SAA and CRP synthesis is triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell types, but mainly from macrophages and monocytes at inflammatory sites
Read the detailed description
Increased serum CRP and SAA levels have been found in a number of disorders, including bacterial infections, malignancies tissue injuries and tissue rejection. Therefore, new studies of early diagnosis, prevention and treatment are needed to improve clinical outcomes.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- serum amyloid A level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum amyloid A levelOther
serum amyloid A level (SAA)
| Study group | Role | What they receive |
|---|---|---|
| Serum amyloid A level in SBP | serum amyloid A level Receives: Other: serum amyloid A level | |
| Serum amyloid A level in cirrhosis | Serum amyloid A level Receives: Other: serum amyloid A level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with elevated serum amyloid A
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
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 Tanta 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Rehab Badawi, Consultant, Principal investigator, Hepatology and gastroenterology dept.-TantaSherief Abd-Elsalam, Consultant, Study chair, Division of Gastroenterology and Hepatology- TantaWalaa Elkhalawany, Consultant, Study chair, Hepatology and gastroenterology dept.-TantaReham Elkhouly, Consultant, Study chair, Hepatology and gastroenterology dept.-TantaMona Watany, Consultant, Study chair, clinical pathology dept.-TantaSamah Soliman, Consultant, Study chair, Hepatology and gastroenterology dept.-TantaMai Khalaf, resident, Study chair, hepatology dept.-Tanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759497
- Sponsor's protocol ID
- sbp diagnosis
- Status last verified
- Jun 2017
- First submitted
- 1 May 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT02759497
- Acronym / sponsor ID
- sbp diagnosis
- Conditions
- Spontaneous Bacterial Peritonitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 3 May 2016 (estimated)
- 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.
One of the most common and serious complications in decompensated cirrhotic patients (DCPs) is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections, pneumonia and cellulitis.
Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and macrophages can also produce these proteins. The induction of SAA and CRP synthesis is triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell types, but mainly from macrophages and monocytes at inflammatory sites
Detailed description
Increased serum CRP and SAA levels have been found in a number of disorders, including bacterial infections, malignancies tissue injuries and tissue rejection. Therefore, new studies of early diagnosis, prevention and treatment are needed to improve clinical outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serum amyloid A level in SBP | – | Other: serum amyloid A levelserum amyloid A level |
| Serum amyloid A level in cirrhosis | – | Other: serum amyloid A levelSerum amyloid A level |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Decompensated cirrhosis with SBP Decompensated cirrhosis without SBP
Key inclusion criteria (5 listed)
- • Decompansated cirrhosis with ascites, defined by a combination of any of the following:
Key exclusion criteria (6 listed)
- Creatinine>1.5 mg/dl
- Other infection e.grespiratory,UTI ,gastrointestinal and skin infection.
- Hepatocellular carcinoma
- Other extrahepatic malignancy e.g ; chest
- Any significant psychiatric illness or other medical comorbidity.
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 |
|---|---|---|
| serum amyloid A levelserum amyloid A level (SAA) | Other | Serum amyloid A level in SBP, Serum amyloid A level in cirrhosis |
Primary outcome
Number of patients with elevated serum amyloid A
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Rehab Badawi, Consultant principal investigator
Hepatology and gastroenterology dept.-Tanta
Sherief Abd-Elsalam, Consultant study chair
Division of Gastroenterology and Hepatology- Tanta
Walaa Elkhalawany, Consultant study chair
Hepatology and gastroenterology dept.-Tanta
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 Tanta 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, Consultant (00201095159522, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with elevated serum amyloid A (time frame: 6months). 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 20 Jun 2017.