Spontaneous Bacterial PeritonitisPhase 3NCT04746937
Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis
A Phase 3 study testing Nitazoxanide and Norfloxacin in people with Spontaneous Bacterial Peritonitis, run by Tanta University.
Trial summary
the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Nitazoxanide and Norfloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to May 2022
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis.
Who cannot join
- Exclusion criteria included active gastrointestinal bleeding Hepatic encephalopathy (>grade 2) Hepatocellular carcinoma (HCC) or other malignancies Allergy to used medications.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.
Read the detailed description
due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of NTZ as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Nitazoxanide, Norfloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called NTZ
nitazoxanide adjuvant to standard therapy
NorfloxacinDrug
Standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | They will receive standard therapy plus placebo Receives: Drug: Norfloxacin |
| Nitazoxanide Group | Active comparator | They will receive standard therapy plus nitazoxanide Receives: Drug: Nitazoxanide; Drug: Norfloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Secondary Spontaneous Bacterial Peritonitis
Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group
Measured: 3 months
Secondary outcomes (1)
Change in Biological Biomarkers
Measurement of Tumor necrosis factor alfa , Procalcitonin(PCT), C-Reactive protein(CRP) and Erythrocyte sedimentation rate(ESR) with further calculation of PEC index [PEC index = PCT × (ESR + CRP)] before and after trial period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (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
- Model description
- Randomized Double-Blind Placebo-Controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mostafa Elasawy AlTaras, Tanta University
- Investigators
- Sahar M. Elhagar, Professor, Study director, Supervisor for my master degree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746937
- Sponsor's protocol ID
- NTZ in Prevention of SBP
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04746937
- Acronym / sponsor ID
- NTZ in Prevention of SBP
- Conditions
- Spontaneous Bacterial Peritonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 10 Feb 2021 (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 study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.
Detailed description
due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of NTZ as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Double-Blind Placebo-Controlled study
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: NorfloxacinThey will receive standard therapy plus placebo |
| Nitazoxanide Group | Active comparator | Drug: Nitazoxanide, Drug: NorfloxacinThey will receive standard therapy plus nitazoxanide |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis.
Key exclusion criteria (1 listed)
- Exclusion criteria included active gastrointestinal bleeding Hepatic encephalopathy (>grade 2) Hepatocellular carcinoma (HCC) or other malignancies Allergy to used medications.
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 |
|---|---|---|
| NitazoxanideAlso: NTZnitazoxanide adjuvant to standard therapy | Drug | Nitazoxanide Group |
| NorfloxacinStandard therapy | Drug | Control Group, Nitazoxanide Group |
Primary outcome
Prevention of Secondary Spontaneous Bacterial Peritonitis
Time frame: 3 months
Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group
1 secondary outcome
Change in Biological Biomarkers
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
Related trials for Spontaneous Bacterial Peritonitis
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Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
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N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
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Not yet recruitingPhase 4
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. This study is not recruiting at the moment.
Sahar M. Elhagar, Professor study director
Supervisor for my master degree
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitazoxanide and Norfloxacin in people with Spontaneous Bacterial Peritonitis, run by Tanta 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 10 Feb 2021. 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. Some participants in this study may receive a placebo. 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 eslam M. Altaras (00201010730130, PG_88188@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of Secondary Spontaneous Bacterial Peritonitis (time frame: 3 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 10 Feb 2021.