Active substance: Norfloxacin
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Clonidine 0. In principle, all patients with cirrhosis of the liver who have already developed ascites but not SBP, are eligible for the trial.
Particularly, SBP has to be excluded and ascitic protein content has to be determined by a clinically indicated index paracentesis maximally 10 days prior to baseline visit. Patients who cannot undergo paracentesis because of small amounts of ascites can only be included in the trial if SBP is unlikely taking into account clinical and blood test indicators.
A randomized allocation of the study participants in one of the two treatment arms ratio 1:1 will be performed.
The remaining measures in both treatment arms are identical so that neither the patient nor the investigator know which arm the patient is assigned to double-blind.
One half of the patients will then receive a daily dose of norfloxacin capsule of 400 mg over a time period of 12 months, while the other half in the control-arm receive an identical-looking capsule with an inactive ingredient placebo over 12 months.
In this multicenter national study, patients will be recruited at a minimum of 13 participating referral centers.
These centers have specific clinical expertise in treating patients with advanced liver diseases, and ten of them are centers for liver transplantation. These centers were also selected because of their experience in conducting randomized, controlled trials, their specialized outpatient structure and their collaboration with local primary and secondary care hospitals.
The secondary aims are to evaluate if the frequencies of SBP and other clinically relevant infections necessitating antibiotic treatment for example, urinary tract infection, pneumonia, sepsis, bacteremia, as well as the total duration of unplanned hospitalization due to cirrhosis, differ between study arms.
In addition, safety aspects, including the impact of norfloxacin on the intestinal microbiome, will be addressed.
Table 2 Study endpoints Full size table Frequency and scope of study visits and interventions All patients who have already developed ascites should be screened for trial participation. Particularly, SBP has to be excluded, and ascitic protein content has to be determined by a clinically indicated index paracentesis maximally 10 days prior to baseline visit.
Patients who cannot undergo paracentesis because of small amounts of ascites can be included in the trial only if SBP is unlikely, taking into account clinical and blood test indicators. Hereafter potentially eligible patients must be informed about the study and genetic testing by an investigator with the use of a specific information sheet.
Patients who fulfill all inclusion criteria but no exclusion criteria proceed to randomization.
Treatment with the study medication must be initiated within 7 days after randomization. Adverse reactions to the study medication are more likely to occur early after treatment initiation, so that closely scheduled visits are implemented for the first 4 weeks.
Patients with cirrhosis fight a tenfold risk for bacterial infections. Do clear keep out-of-date or by medicines.