Spontaneous Bacterial PeritonitisPhase 4NCT05427747
Meropenem vs Cefotaxime as Empirical Treatment of SBP
A Phase 4 study testing cefotaxime in people with Spontaneous Bacterial Peritonitis, run by Assiut University.
Trial summary
We aimed to evaluate whether meropenem is superior to cefotaxime for treatment of SBP empirically. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- cefotaxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to Feb 2024
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis patients with ascites Ascitic fluid PMN cell count >250/mm3 Age: 18:80
Who cannot join
- : history of abdominal surgery within 4 weeks, secondary peritonitis, tuberculous peritonitis, Malignant tumor, patients who use hormones or immunosuppressants, AIDS patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Meropenem vs Cefotaxime as Empirical Treatment of Spontaneous Bacterial Peritonitis :Prospective Randomized Clinical Trial
We aimed to evaluate whether meropenem is superior to cefotaxime for treatment of SBP empirically.
Read the detailed description
Ascites is the most frequent complication of cirrhosis and represents a significant change for the patient because the impact on mortality and quality of life is important.
Spontaneous bacterial peritonitis (SBP) is a dreaded complication in patients with decompensated cirrhosis.
Spontaneous bacterial peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. It is defined by the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy.
Spontaneous bacterial peritonitis carries a mortality rate of 30 to 70% in patients with end-stage liver and kidney disease.
Choice of antibiotic is dependent on type of microbes responsible for infection. Gram negative enteric bacteria are considered the most common pathogens responsible for SBP. This is the reason, 3rd generation cephalosporins are the recommended drugs of choice for treating SBP empirically. But recent studies have shown that Cephalosporins are effective only in 70% of community acquired and 56% of hospital acquired SBP.It is most likely due to changing bacterial pathogens of SBP over last two decades as now gram positive bacteria and multi drug resistance organism (MDRO) are increasingly being isolated in SBP. It is the consequence of undue, over the counter misuse of cephalosporins in community and frequent exposure of cirrhosis patients to these drugs during recurrent hospital admissions.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- cefotaxime
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefotaximeDrug
Also called meropenem
One group will be given cefotaxime and another group meropenem.
The efficacy of antibiotic therapy will be checked with:
- Follow-up paracentesis after 48 hours of initiation of empiric antibiotic treatment showing reduction in neutrophil count of at least 25% .
- Decrease of peritoneal fluid PMN count to < 250 cells/μ at end of treatment and negative previously positive ascitic fluid culture.
| Study group | Role | What they receive |
|---|---|---|
| cefotaxime | Experimental | ceotaxime 2g iv /8hr Receives: Drug: cefotaxime |
| meropenem | Experimental | meropenem 1g iv /8hr Receives: Drug: cefotaxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment within 5 days
The response to therapy is defined as the reduction of polymorphonuclear leukocytes (PMN) count in ascitic fluid more than 25 % from baseline after 48 hours and as a PMN count in ascitic fluid less then 250/mm³ after 5 days
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha Hussein Kawashty Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427747
- Sponsor's protocol ID
- Meropenem vs cefotaxime in SBP
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Finci L, Mouraux S, Knuchel J, Bochatay L. [Initial management of new onset ascites in patient with cirrhosis]. Rev Med Suisse. 2017 Sep 6;13(573):1509-1515. French.
PubMed 28876707Sarwar S, Tarique S, Waris U, Khan AA. Cephalosporin resistance in community acquired spontaneous bacterial peritonitis. Pak J Med Sci. 2019 Jan-Feb;35(1):4-9. doi: 10.12669/pjms.35.1.17.
PubMed 30881387Wiest R, Krag A, Gerbes A. Spontaneous bacterial peritonitis: recent guidelines and beyond. Gut. 2012 Feb;61(2):297-310. doi: 10.1136/gutjnl-2011-300779. Epub 2011 Dec 6. No abstract available.
PubMed 22147550Ameer MA, Foris LA, Mandiga P, Haseeb M. Spontaneous Bacterial Peritonitis. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448208/
PubMed 28846337
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meropenem vs Cefotaxime as Empirical Treatment of Spontaneous Bacterial Peritonitis :Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05427747
- Acronym / sponsor ID
- Meropenem vs cefotaxime in SBP
- Conditions
- Spontaneous Bacterial Peritonitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Jun 2022 (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.
We aimed to evaluate whether meropenem is superior to cefotaxime for treatment of SBP empirically.
Detailed description
Ascites is the most frequent complication of cirrhosis and represents a significant change for the patient because the impact on mortality and quality of life is important.
Spontaneous bacterial peritonitis (SBP) is a dreaded complication in patients with decompensated cirrhosis.
Spontaneous bacterial peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. It is defined by the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy.
Spontaneous bacterial peritonitis carries a mortality rate of 30 to 70% in patients with end-stage liver and kidney disease.
Choice of antibiotic is dependent on type of microbes responsible for infection. Gram negative enteric bacteria are considered the most common pathogens responsible for SBP. This is the reason, 3rd generation cephalosporins are the recommended drugs of choice for treating SBP empirically. But recent studies have shown that Cephalosporins are effective only in 70% of community acquired and 56% of hospital acquired SBP.It is most likely due to changing bacterial pathogens of SBP over last two decades as now gram positive bacteria and multi drug resistance organism (MDRO) are increasingly being isolated in SBP. It is the consequence of undue, over the counter misuse of cephalosporins in community and frequent exposure of cirrhosis patients to these drugs during recurrent hospital admissions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cefotaxime | Experimental | Drug: cefotaximeceotaxime 2g iv /8hr |
| meropenem | Experimental | Drug: cefotaximemeropenem 1g iv /8hr |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Liver cirrhosis patients with ascites Ascitic fluid PMN cell count >250/mm3 Age: 18:80
Key exclusion criteria (1 listed)
- : history of abdominal surgery within 4 weeks, secondary peritonitis, tuberculous peritonitis, Malignant tumor, patients who use hormones or immunosuppressants, AIDS patients.
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 |
|---|---|---|
| cefotaximeAlso: meropenemOne group will be given cefotaxime and another group meropenem. The efficacy of antibiotic therapy will be checked with: * Follow-up paracentesis after 48 hours of initiation of empiric antibiotic treatment showing reduction in neutrophil count of at least 25% . * Decrease of peritoneal fluid PMN count to < 250 cells/μ at end of treatment and negative previously positive ascitic fluid culture. | Drug | cefotaxime, meropenem |
Primary outcome
Response to treatment within 5 days
Time frame: 5 days
The response to therapy is defined as the reduction of polymorphonuclear leukocytes (PMN) count in ascitic fluid more than 25 % from baseline after 48 hours and as a PMN count in ascitic fluid less then 250/mm³ after 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Results publication: PubMed 28876707Finci L, Mouraux S, Knuchel J, Bochatay L. [Initial management of new onset ascites in patient with cirrhosis]. Rev Med Suisse. 2017 Sep 6;13(573):1509-1515. French.
- Results publication: PubMed 30881387Sarwar S, Tarique S, Waris U, Khan AA. Cephalosporin resistance in community acquired spontaneous bacterial peritonitis. Pak J Med Sci. 2019 Jan-Feb;35(1):4-9. doi: 10.12669/pjms.35.1.17.
- Results publication: PubMed 22147550Wiest R, Krag A, Gerbes A. Spontaneous bacterial peritonitis: recent guidelines and beyond. Gut. 2012 Feb;61(2):297-310. doi: 10.1136/gutjnl-2011-300779. Epub 2011 Dec 6. No abstract available.
- Results publication: PubMed 28846337Ameer MA, Foris LA, Mandiga P, Haseeb M. Spontaneous Bacterial Peritonitis. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448208/
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cefotaxime in people with Spontaneous Bacterial Peritonitis, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Taha hussein Abdelrahman, resident (+201114236391 ext. +201068012930, elsheriftaha74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment within 5 days (time frame: 5 days). 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 NCT05427747, which also lists 4 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 22 Jun 2022.