Spontaneous Bacterial PeritonitisPhase 3NCT06234046
Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin
A Phase 3 study testing Rifaximin 550Mg Tab, Ciprofloxacin 750 MG and ascitic fluid sample in people with Spontaneous Bacterial Peritonitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this Randomized controlled trial is to assessment the efficacy of Rifaximin as a prophylaxis of SBP in comparison with ciprofloxacin in Egyptian patients. This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Rifaximin 550Mg Tab, Ciprofloxacin 750 MG and ascitic fluid sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2023to 15 Dec 2023
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cirrhotic liver disease patients with ascites just recovered from SBP attack.
- Must be able to swallow tablets
Who cannot join
- Cases with metastatic HCC.
- patients with drug allergy from Ciprofloxacin or Rifaximin.
- those having ascites secondary to other causes rather than liver cirrhosis.
- those having gastroenterology malignancy.
- patients on immunotherapy.
- HIV patients.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this Randomized controlled trial is to assessment the efficacy of Rifaximin as a prophylaxis of SBP in comparison with ciprofloxacin in Egyptian patients.
This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as; Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period and group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.
Read the detailed description
This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as;
- Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.
- Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
The included cases were collected from hepatology outpatient clinic and inpatient department at Ain shams University hospital between May 2023 and November 2023 after the scientific ethical committee approval. A written consent was obtained from the included cases.
Cases with metastatic HCC, patients with drug allergy from Ciprofloxacin or Rifaximin, those having ascites secondary to other causes rather than liver cirrhosis, those having gastroenterology malignancy, patients on immunotherapy, and HIV patients were all excluded from the trial. Before starting the trial, the all cases were diagnosed as SBP with ascitic fluid sample with polymorphonuclear cell count more than 250 cells /µL and received medical treatment of SBP according to EASL guidelines for treatment of SBP.
All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.
All included patients went through a comprehensive medical history, full physical assessment as well as full laboratory examination including; CBC, liver profile (ALT, AST, ALP, GGT, total \& direct bilirubin, serum albumin, serum total proteins), kidney function tests (S.creat, BUN), ascitic fluid sample was taken from every patients at the starting of the trial to make sure the recovery from the previous SBP attack (AFS1) and another sample was taken once the patient was suspected to have another attack of SBP or after 6 months of treatment (AFS2). The ascitic samples were subjected to analysis of the differential cell count and measurement of ascitic albumin, glucose, total proteins and LDH, culture and sensitivity were assessed. The Child-Pugh's score were assessed, and pelvi-abdominal ultrasound were done for all patients.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Rifaximin 550Mg Tab, Ciprofloxacin 750 MG, ascitic fluid sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin 550Mg TabDrug
Also called gastrobiotic
group (1) received Rifaximin as 550 mg twice daily dosage for six months.
Ciprofloxacin 750 MGDrug
Also called Cipro
group (2) received Ciprofloxacin 750 mg tab mg once weekly dosage for six months.
ascitic fluid sampleDiagnostic test
Also called aspiration of ascitic fluid
aspiration of ascitic fluid sample and analysis for differential cell count
| Study group | Role | What they receive |
|---|---|---|
| group (1) | Active comparator | Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period. Receives: Drug: Rifaximin 550Mg Tab; Diagnostic Test: ascitic fluid sample |
| group (2) | Active comparator | Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period. Receives: Drug: Ciprofloxacin 750 MG; Diagnostic Test: ascitic fluid sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of Rifaximin as a prophylactic treatment for SBP.
comparison between Rifaximin and Ciprofloxacin when used as a prophylaxis for the recurrence of SBP.
Measured: All patients of the two groups were followed up for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start28 May 2023
- Primary completion30 Nov 2023
- Study completion15 Dec 2023
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 Ain Shams 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled trial was performed on two groups of Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack, group (1) included 40 patients were administered Rifaximin as 550 mg twice daily dosage for six months and group (2)included 40 patients were administered Ciprofloxacin as 750 mg once weekly dose for 6 months. All patients of the two groups were followed up for recurrence of SBP for 6 months.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234046
- Sponsor's protocol ID
- FMASU R140/2023
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin
- ClinicalTrials.gov ID
- NCT06234046
- Acronym / sponsor ID
- FMASU R140/2023
- Conditions
- Spontaneous Bacterial Peritonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 31 Jan 2024 (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.
The goal of this Randomized controlled trial is to assessment the efficacy of Rifaximin as a prophylaxis of SBP in comparison with ciprofloxacin in Egyptian patients.
This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as; Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period and group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.
Detailed description
This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as;
- Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.
- Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
The included cases were collected from hepatology outpatient clinic and inpatient department at Ain shams University hospital between May 2023 and November 2023 after the scientific ethical committee approval. A written consent was obtained from the included cases.
Cases with metastatic HCC, patients with drug allergy from Ciprofloxacin or Rifaximin, those having ascites secondary to other causes rather than liver cirrhosis, those having gastroenterology malignancy, patients on immunotherapy, and HIV patients were all excluded from the trial. Before starting the trial, the all cases were diagnosed as SBP with ascitic fluid sample with polymorphonuclear cell count more than 250 cells /µL and received medical treatment of SBP according to EASL guidelines for treatment of SBP.
All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.
All included patients went through a comprehensive medical history, full physical assessment as well as full laboratory examination including; CBC, liver profile (ALT, AST, ALP, GGT, total \& direct bilirubin, serum albumin, serum total proteins), kidney function tests (S.creat, BUN), ascitic fluid sample was taken from every patients at the starting of the trial to make sure the recovery from the previous SBP attack (AFS1) and another sample was taken once the patient was suspected to have another attack of SBP or after 6 months of treatment (AFS2). The ascitic samples were subjected to analysis of the differential cell count and measurement of ascitic albumin, glucose, total proteins and LDH, culture and sensitivity were assessed. The Child-Pugh's score were assessed, and pelvi-abdominal ultrasound were done for all patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized controlled trial was performed on two groups of Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack, group (1) included 40 patients were administered Rifaximin as 550 mg twice daily dosage for six months and group (2)included 40 patients were administered Ciprofloxacin as 750 mg once weekly dose for 6 months. All patients of the two groups were followed up for recurrence of SBP for 6 months.
| Arm | Type | Receives |
|---|---|---|
| group (1) | Active comparator | Drug: Rifaximin 550Mg Tab, Diagnostic Test: ascitic fluid sampleGroup (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period. |
| group (2) | Active comparator | Drug: Ciprofloxacin 750 MG, Diagnostic Test: ascitic fluid sampleGroup (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cirrhotic liver disease patients with ascites just recovered from SBP attack.
- Must be able to swallow tablets
Key exclusion criteria (6 listed)
- Cases with metastatic HCC.
- patients with drug allergy from Ciprofloxacin or Rifaximin.
- those having ascites secondary to other causes rather than liver cirrhosis.
- those having gastroenterology malignancy.
- patients on immunotherapy.
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 |
|---|---|---|
| Rifaximin 550Mg TabAlso: gastrobioticgroup (1) received Rifaximin as 550 mg twice daily dosage for six months. | Drug | group (1) |
| Ciprofloxacin 750 MGAlso: Ciprogroup (2) received Ciprofloxacin 750 mg tab mg once weekly dosage for six months. | Drug | group (2) |
| ascitic fluid sampleAlso: aspiration of ascitic fluidaspiration of ascitic fluid sample and analysis for differential cell count | Diagnostic test | group (1), group (2) |
Primary outcome
The efficacy of Rifaximin as a prophylactic treatment for SBP.
Time frame: All patients of the two groups were followed up for 6 months.
comparison between Rifaximin and Ciprofloxacin when used as a prophylaxis for the recurrence of SBP.
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 31 Jan 2024.
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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.
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 Phase 3 study testing Rifaximin 550Mg Tab, Ciprofloxacin 750 MG and ascitic fluid sample in people with Spontaneous Bacterial Peritonitis, run by Ain Shams 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 2 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: finished, as of the sponsor's last update on 31 Jan 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The efficacy of Rifaximin as a prophylactic treatment for SBP. (time frame: All patients of the two groups were followed up for 6 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 31 Jan 2024.