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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | They will receive standard therapy plus placebo |
|
| Nitazoxanide Group | Active Comparator | They will receive standard therapy plus nitazoxanide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | nitazoxanide adjuvant to standard therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of Secondary Spontaneous Bacterial Peritonitis | Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| eslam M. Altaras | Contact | 00201010730130 | PG_88188@pharm.tanta.edu.eg | |
| tarek M. Mostafa, A. Professor | Contact | 00201154594035 | Tarek.mostafa@pharm.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sahar M. Elhagar, Professor | Supervisor for my master degree | Study Director |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
| D009643 | Norfloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Randomized Double-Blind Placebo-Controlled study
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| Norfloxacin | Drug | Standard therapy |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |