Spontaneous Bacterial PeritonitisPhase 3NCT04161768
Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
A Phase 3 study testing Norfloxacin and Itopride in people with Spontaneous Bacterial Peritonitis, run by Tanta University at 1 site in Egypt.
Trial summary
Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Norfloxacin and Itopride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- cirrhotic patients with ascites who had previous episodes of SBP.
Who cannot join
- 1. Allergy or contraindication for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam
About this study
Official title: Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Read the detailed description
Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Norfloxacin, Itopride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorfloxacinDrug
Also called Epinor
Norfloxacin 400 mg daily
ItoprideDrug
Also called Ganaton
Itopride 50 mg three times daily
| Study group | Role | What they receive |
|---|---|---|
| Norfloxacin | Active comparator | Norfloxacin 400 mg daily Receives: Drug: Norfloxacin |
| Norfloxacin and Itopride | Experimental | Norfloxacin 400 mg daily and Itopride 50 mg three times daily. Receives: Drug: Norfloxacin; Drug: Itopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bouts of recurrence during treatment.
The recurrence of infection during treatment.
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 posted13 Nov 2019
- Study start1 Dec 2018
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 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
- Afaf Younes Mohammed Younes, Msc, Principal investigator, Tanta University - Faculty of MedicineMona Ahmed Helmy Shehata, Prof., Principal investigator, Tanta University - Faculty of MedicineSherief Abd-Elsalam, Ass. Prof., Principal investigator, Tanta University - Tropical Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161768
- Sponsor's protocol ID
- SBP Management
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT04161768
- Acronym / sponsor ID
- SBP Management
- Conditions
- Spontaneous Bacterial Peritonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 13 Nov 2019 (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.
Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Detailed description
Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norfloxacin | Active comparator | Drug: NorfloxacinNorfloxacin 400 mg daily |
| Norfloxacin and Itopride | Experimental | Drug: Norfloxacin, Drug: ItoprideNorfloxacin 400 mg daily and Itopride 50 mg three times daily. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- cirrhotic patients with ascites who had previous episodes of SBP.
Key exclusion criteria (1 listed)
- 1. Allergy or contraindication for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. 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 |
|---|---|---|
| NorfloxacinAlso: EpinorNorfloxacin 400 mg daily | Drug | Norfloxacin, Norfloxacin and Itopride |
| ItoprideAlso: GanatonItopride 50 mg three times daily | Drug | Norfloxacin and Itopride |
Primary outcome
Number of bouts of recurrence during treatment.
Time frame: 6 months
The recurrence of infection during treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
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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
Cirrhosis With Spontaneous Bacterial Peritonitis
Not yet recruitingObservational study
Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.
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.
Afaf Younes Mohammed Younes, Msc principal investigator
Tanta University - Faculty of Medicine
Mona Ahmed Helmy Shehata, Prof. principal investigator
Tanta University - Faculty of Medicine
Sherief Abd-Elsalam, Ass. Prof. principal investigator
Tanta University - Tropical Medicine Department
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 Norfloxacin and Itopride in people with 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 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: looking for participants now, as of the sponsor's last update on 13 Nov 2019. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, 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 bouts of recurrence during treatment. (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 13 Nov 2019.