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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norfloaxcin arm | Active Comparator | patients to receive norflxacin 400mg daily |
|
| Nitazoxaide arm | Active Comparator | patients to receive nitazoxaide 500mg daily |
|
| Colisitn arm | Active Comparator | patients to receive Colistin 15 ml three times daily, totalling 2,25 MIU/ day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norfloxacin 400 MG | Drug | Patients receiving Norfloxacin 400 Mg to prevent SBP |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 3 months, and 6 months |
| White Blood Cell (WBC) Count Reduction |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (Safety Assessment) | Definition: Frequency and severity of treatment-related side effects (e.g., diarrhea, nephrotoxicity, hypersensitivity reactions). Measurement: Patient-reported symptoms and clinical examination findings. | Throughout study duration (0-6 months) |
Inclusion Criteria:
Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University, Faculty of Medicine | Tanta | Egypt |
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| ID | Term |
|---|---|
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009643 | Norfloxacin |
| C041747 | nitazoxanide |
| D003091 | Colistin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Nitazoxanide 500 MG |
| Drug |
Patients receiving Nitazoxaide 500 Mg to prevent SBP |
|
| Colistin | Drug | Patients receiving Colistin 15ml three times/ day to prevent SBP |
|
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. |
| 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). | Baseline, 3 months, and 6 months |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |