Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
-Consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with spontaneous bacterial peritonitis will be evaluated
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norfloxacin with GM-CSF | Experimental | Oral Norfloxacin 400mg daily and GM-CSF (Granulocyte-Macrophage colony-stimulating factor) in a dose of 1.5mcg/kg over 4 hour infusion every 15 days will be given in Group B |
|
| Norfloxacin | Active Comparator | Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMCSF | Drug | GMCSF 1.5mcg/Kg |
| |
| Norfloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups | Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid | 6 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ). | Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid. | 4 weeks |
| Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Tablet Norfloxacin 400 mg |
|
Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid. |
| 12 weeks |
| Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ). | Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid. | 24 weeks |
| Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ). | Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid. | 48 weeks |
| ID | Term |
|---|---|
| D009643 | Norfloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided