Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT00570960
Eligibility Criteria:
Inclusion Criteria:
* Meets all criteria for SBP as outlined below:
* Ascites fluid analysis showing greater than or equal to 250 PMN permm3 as reported by automated or manual differential cell count
* Lack of source of secondary peritonitis (e.g. appendicitis, acute cholecystitis)
* Lack of a ruptured hollow viscous resulting in peritoneal soilage with multiple organisms
* Age \> 18
* No antibiotic treatment within seven days prior to the diagnosis of SBP (except routine prophylaxis for SBP or initial empiric antibiotics at the time of diagnosis)
* Absence of other clinical infections
* Lack of any other systemic disease that could limit lifespan to less than 90 days
* Serum creatinine \<3.0 mg/dL or calculated GFR\>15 ml/min
* Serum international normalized ratio (INR)\<3.0
Exclusion Criteria:
* Known hypersensitivity to a component of either of the study drugs
* Unwillingness to undergo diagnostic paracentesis
* Inability or unwillingness to give informed consent for study participation
* Shock or hemodynamic instability
* Active, clinically evident gastrointestinal bleeding, excluding heme-positive stools only
* Active congestive heart failure or inability to tolerate fluid volumes of study drugs
* Uncontrolled diabetes mellitus or hyperglycemia \>400 mg/dl at screening
* Evidence for organic nephropathy, e.g. proteinuria \>2+ on spot urine, hematuria\>15 RBC's per HPF, abnormality on renal ultrasound
* Clinical history of severe volume depletion (i.e. severe diarrhea or brisk response to diuretics) within one week of diagnosis of SBP
* Laparotomy within the past 30 days prior to diagnosis of SBP
* Peritoneovenous shunt in place (i.e. Denver or LaVeen shunt)
* Prison inmate or resident of psychiatric facility
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00570960
Study Brief:
Protocol Section:
NCT00570960