Spontaneous Bacterial PeritonitisPhase 43C-SPSNCT06827756
Comparative Study of Secondary Prophylaxis for SBP
A Phase 4 study testing Norfloxacin 400 MG, Nitazoxanide 500 MG and Colistin in people with Spontaneous Bacterial Peritonitis and Cirrhoses, Liver, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spontaneous Bacterial Peritonitis, Cirrhoses, Liver, Ascites
- What is being tested?
- Norfloxacin 400 MG, Nitazoxanide 500 MG and Colistin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Feb 2022
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.
- Ascitic patients diagnosed with Spontaneous Bacterial Peritonitis (SBP) by paracentesis.
- Ascitic fluid polymorphonuclear (PMN) cell count > 250/mm³.
- Age 50 years to 80 years.
- Willing to provide informed consent.
Who cannot join
- Pregnant or breastfeeding females.
- History of allergic reactions to Norfloxacin, Nitazoxanide, or Colistin.
- Patients with recurrent spontaneous peritonitis.
- Presence of gastrointestinal hemorrhage.
- Renal failure (Creatinine > 2 mg/dL or on dialysis).
- Presence of severe infection-related sequelae (e.g., persistent fever, abdominal discomfort, sepsis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis
The goal of this clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:
Are nitazoxanide and colistin as effective as norfloxacin in preventing recurrent SBP?
Read more
What medical outcomes do participants experience when taking norfloxacin, nitazoxanide, or colistin?
Researchers will compare norfloxacin, nitazoxanide, and colistin to determine their effectiveness in preventing SBP recurrence in cirrhotic patients.
Participants will:
Be randomly assigned to receive either 400 mg norfloxacin daily, 500 mg nitazoxanide twice daily, or 15 ml colistin syrup three times daily (2.25 MIU total per day).
Undergo regular blood tests and ascitic fluid analysis at discharge, 2 months, and 6 months post-treatment.
Be monitored for any side effects and recurrence of SBP.
- Conditions
- Spontaneous Bacterial Peritonitis, Cirrhoses, Liver, Ascites
- Being tested
- Norfloxacin 400 MG, Nitazoxanide 500 MG, Colistin
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norfloxacin 400 MGDrug
Patients receiving Norfloxacin 400 Mg to prevent SBP
Nitazoxanide 500 MGDrug
Patients receiving Nitazoxaide 500 Mg to prevent SBP
ColistinDrug
Patients receiving Colistin 15ml three times/ day to prevent SBP
| Study group | Role | What they receive |
|---|---|---|
| Norfloaxcin arm | Active comparator | patients to receive norflxacin 400mg daily Receives: Drug: Norfloxacin 400 MG |
| Nitazoxaide arm | Active comparator | patients to receive nitazoxaide 500mg daily Receives: Drug: Nitazoxanide 500 MG |
| Colisitn arm | Active comparator | patients to receive Colistin 15 ml three times daily, totalling 2,25 MIU/ day Receives: Drug: Colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Spontaneous Bacterial Peritonitis (SBP)
Definition: The percentage of patients experiencing a recurrence of SBP within 6 months of treatment initiation.
Measurement: Diagnosis confirmed by ascitic fluid analysis (PMN count > 250 cells/mm³ and positive culture).
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (3)
C-Reactive Protein (CRP) Reduction
Definition: A decrease in CRP levels, indicating a reduction in systemic inflammation.
Measurement: CRP levels measured in mg/L.
Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.
Measured: Baseline, 1 month, 3 months, and 6 months
White Blood Cell (WBC) Count Reduction
Definition: Reduction in WBC count as a marker of infection control.
Measurement: WBC count measured in x10³/µL.
Success Criteria: A return to normal WBC count (<10,000/µL) by 3 months.
Measured: Baseline, 1 month, 3 months, and 6 months
Renal Function Stability
Definition: Prevention of renal impairment during treatment.
Measurement: Serum Creatinine (mg/dL) and Blood Urea Nitrogen (BUN) (mg/dL).
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Mar 2021
- Primary completion1 Dec 2021
- Study completion1 Feb 2022
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ahmed Esmat, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827756
- Sponsor's protocol ID
- 33045/04/19
- Acronym
- 3C-SPS
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis
- ClinicalTrials.gov ID
- NCT06827756
- Acronym / sponsor ID
- 3C-SPS / 33045/04/19
- Conditions
- Spontaneous Bacterial Peritonitis, Cirrhoses, Liver, Ascites
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 14 Feb 2025 (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 clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:
Are nitazoxanide and colistin as effective as norfloxacin in preventing recurrent SBP?
What medical outcomes do participants experience when taking norfloxacin, nitazoxanide, or colistin?
Researchers will compare norfloxacin, nitazoxanide, and colistin to determine their effectiveness in preventing SBP recurrence in cirrhotic patients.
Participants will:
Be randomly assigned to receive either 400 mg norfloxacin daily, 500 mg nitazoxanide twice daily, or 15 ml colistin syrup three times daily (2.25 MIU total per day).
Undergo regular blood tests and ascitic fluid analysis at discharge, 2 months, and 6 months post-treatment.
Be monitored for any side effects and recurrence of SBP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Norfloaxcin arm | Active comparator | Drug: Norfloxacin 400 MGpatients to receive norflxacin 400mg daily |
| Nitazoxaide arm | Active comparator | Drug: Nitazoxanide 500 MGpatients to receive nitazoxaide 500mg daily |
| Colisitn arm | Active comparator | Drug: Colistinpatients to receive Colistin 15 ml three times daily, totalling 2,25 MIU/ day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.
- Ascitic patients diagnosed with Spontaneous Bacterial Peritonitis (SBP) by paracentesis.
- Ascitic fluid polymorphonuclear (PMN) cell count > 250/mm³.
- Age 50 years to 80 years.
- Willing to provide informed consent.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding females.
- History of allergic reactions to Norfloxacin, Nitazoxanide, or Colistin.
- Patients with recurrent spontaneous peritonitis.
- Presence of gastrointestinal hemorrhage.
- Renal failure (Creatinine > 2 mg/dL or on dialysis).
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 |
|---|---|---|
| Norfloxacin 400 MGPatients receiving Norfloxacin 400 Mg to prevent SBP | Drug | Norfloaxcin arm |
| Nitazoxanide 500 MGPatients receiving Nitazoxaide 500 Mg to prevent SBP | Drug | Nitazoxaide arm |
| ColistinPatients receiving Colistin 15ml three times/ day to prevent SBP | Drug | Colisitn arm |
Primary outcome
Recurrence of Spontaneous Bacterial Peritonitis (SBP)
Time frame: Baseline, 3 months, and 6 months
Definition: The percentage of patients experiencing a recurrence of SBP within 6 months of treatment initiation. Measurement: Diagnosis confirmed by ascitic fluid analysis (PMN count > 250 cells/mm³ and positive culture).
3 secondary outcomes
C-Reactive Protein (CRP) Reduction
Time frame: Baseline, 1 month, 3 months, and 6 months
White Blood Cell (WBC) Count Reduction
Time frame: Baseline, 1 month, 3 months, and 6 months
Renal Function Stability
Time frame: Baseline, 3 months, and 6 months
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 14 Feb 2025.
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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 4 study testing Norfloxacin 400 MG, Nitazoxanide 500 MG and Colistin in people with Spontaneous Bacterial Peritonitis and Cirrhoses, Liver, 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 5 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 14 Feb 2025. 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 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?
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?
Recurrence of Spontaneous Bacterial Peritonitis (SBP) (time frame: Baseline, 3 months, and 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 14 Feb 2025.