Spontaneous Bacterial PeritonitisNCT02388035
Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis
A study testing Cefotaxime in people with Spontaneous Bacterial Peritonitis, run by Dr Ahmed Ali Elbaz at 1 site in Egypt.
Trial summary
Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Cefotaxime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Jun 2015
- Phase
- Interventional
- 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
Who may be able to join
- patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection
Who cannot join
- Patients were excluded if they received antibiotics ten days prior to the hospital admission or there is evidence of secondary bacterial peritonitis, tuberculous peritonitis, malignant ascites or ascites due to other causes e.g. cardiac or renal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. It is considered to be one of the first choice antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms have been increasingly reported especially to cefotaxime and its effect on the clinical outcome in treating SBP.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Cefotaxime
- Keywords
- profiles changes, microorganisms, cefotaxime, SBP, Egyptian, effective antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefotaximeDrug
| Study group | Role | What they receive |
|---|---|---|
| SBP-group 1 | Experimental | Spontanous bacterial peritonitis Receives: Drug: Cefotaxime |
| CNNA-group 2 | Experimental | Culture negative neutrocytic ascites Receives: Drug: Cefotaxime |
| MNBA-group 3 | Experimental | monomicrobial non-neutrocytic ascites Receives: Drug: Cefotaxime |
| group 4 | No intervention | no evidence of ascitic fluid infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organisms detected with their antibiotics sensitivity
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionJun 2015
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Ahmed Ali Elbaz
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr Ahmed Ali Elbaz, Nasser Institute For Research and Treatment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388035
- Sponsor's protocol ID
- HHAEREDS-2015
- Status last verified
- Jun 2015
- First submitted
- 9 Mar 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT02388035
- Acronym / sponsor ID
- HHAEREDS-2015
- Conditions
- Spontaneous Bacterial Peritonitis
- Keywords
- profiles changes, microorganisms, cefotaxime, SBP, Egyptian, effective antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Dr Ahmed Ali ElbazOther government
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Mar 2015 (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.
Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. It is considered to be one of the first choice antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms have been increasingly reported especially to cefotaxime and its effect on the clinical outcome in treating SBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SBP-group 1 | Experimental | Drug: CefotaximeSpontanous bacterial peritonitis |
| CNNA-group 2 | Experimental | Drug: CefotaximeCulture negative neutrocytic ascites |
| MNBA-group 3 | Experimental | Drug: Cefotaximemonomicrobial non-neutrocytic ascites |
| group 4 | No intervention | –no evidence of ascitic fluid infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection
Key exclusion criteria (1 listed)
- Patients were excluded if they received antibiotics ten days prior to the hospital admission or there is evidence of secondary bacterial peritonitis, tuberculous peritonitis, malignant ascites or ascites due to other causes e.g. cardiac or renal diseases
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 |
|---|---|---|
| Cefotaxime | Drug | CNNA-group 2, MNBA-group 3, SBP-group 1 |
Primary outcome
Organisms detected with their antibiotics sensitivity
Time frame: 8 months
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 4 Jun 2015.
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Clinical Study on the Effectiveness of Antibiotics Combined With Bifidobacterium Quadruple Live Tablets in Treating Cirrhosis With Spontaneous Bacterial Peritonitis and Preventing Recurrence
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefotaxime in people with Spontaneous Bacterial Peritonitis, run by Dr Ahmed Ali Elbaz 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 4 Jun 2015. 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?
Organisms detected with their antibiotics sensitivity (time frame: 8 months). 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 4 Jun 2015.