Spontaneous Bacterial PeritonitisPhase 3SBPNCT02120196
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
A Phase 3 study testing Rifaximin and Norfloxacin in people with Spontaneous Bacterial Peritonitis and Ascites, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis, Ascites, Liver Cirrhosis
- What is being tested?
- Rifaximin and Norfloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous episode of SBP
- Total protein in the ascitic fluid below or equal to 1.5 g/dL
Who cannot join
- Allergy to quinolones
- Antibiotic therapy in the 2 weeks preceding inclusion
- Recent ( within the previous 2 weeks) episode of digestive hemorrhage
- Hepatocellular carcinoma or other neoplasias able to shorten life expectancy
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university hospital
Tanta
Sherief Abd-Elsalam, 00201000040794, Sherif_tropical@yahoo.com
About this study
The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.
Read the detailed description
This study will be carried out on 100 patients with liver cirrhosis and ascites who will be enrolled from Tanta University, Tropical Medicine Department in the period between January 2014 to 6 months. The selected patients will be randomly assigned to receive 400 mg of norfloxacin daily or 1200 mg of rifaximin daily and will be classified into two groups :
Group 1 : 50 patients will be treated with 1200 mg of rifaximin daily. Group 2 : 50 patients will be treated with 400 mg of norfloxacin daily.
- Conditions
- Spontaneous Bacterial Peritonitis, Ascites, Liver Cirrhosis
- Being tested
- Rifaximin, Norfloxacin
- Medical subject headings
- Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Gastrobiotic, Trencedia
rifaximin 1200 mg daily versus norfloxacin 400 mg once daily
NorfloxacinDrug
Also called Epinor
FDA approved:400mg once daily
| Study group | Role | What they receive |
|---|---|---|
| rifaximin | Experimental | Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months. Receives: Drug: Rifaximin |
| norfloxacin | Active comparator | Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months. Receives: Drug: Norfloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recurrence of SBP
The total number of paper of participitants with recurrence of SBP
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Asem A Elfert, Principal investigator, TUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120196
- Sponsor's protocol ID
- Asem Ahmed Elfert
- Acronym
- SBP
- Status last verified
- Jan 2018
- First submitted
- 7 Apr 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT02120196
- Acronym / sponsor ID
- SBP / Asem Ahmed Elfert
- Conditions
- Spontaneous Bacterial Peritonitis, Ascites, Liver Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Jan 2014
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Apr 2014 (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.
The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.
Detailed description
This study will be carried out on 100 patients with liver cirrhosis and ascites who will be enrolled from Tanta University, Tropical Medicine Department in the period between January 2014 to 6 months. The selected patients will be randomly assigned to receive 400 mg of norfloxacin daily or 1200 mg of rifaximin daily and will be classified into two groups :
Group 1 : 50 patients will be treated with 1200 mg of rifaximin daily. Group 2 : 50 patients will be treated with 400 mg of norfloxacin daily.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rifaximin | Experimental | Drug: RifaximinArm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months. |
| norfloxacin | Active comparator | Drug: NorfloxacinArm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous episode of SBP
- Total protein in the ascitic fluid below or equal to 1.5 g/dL
Key exclusion criteria (5 listed)
- Allergy to quinolones
- Antibiotic therapy in the 2 weeks preceding inclusion
- Recent ( within the previous 2 weeks) episode of digestive hemorrhage
- Hepatocellular carcinoma or other neoplasias able to shorten life expectancy
- Pregnant and lactating women
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 |
|---|---|---|
| RifaximinAlso: Gastrobiotic, Trencediarifaximin 1200 mg daily versus norfloxacin 400 mg once daily | Drug | rifaximin |
| NorfloxacinAlso: EpinorFDA approved:400mg once daily | Drug | norfloxacin |
Primary outcome
Number of participants with recurrence of SBP
Time frame: 6 months
The total number of paper of participitants with recurrence of SBP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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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.
Asem A Elfert principal investigator
TUH
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 and Norfloxacin in people with Spontaneous Bacterial Peritonitis and Ascites, run by Sherief Abd-Elsalam 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 5 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 9 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief M. Abd-Elsalam, Lecturer (00201000040794, Sheif_tropical@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with recurrence of SBP (time frame: 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 9 Jan 2018.