Microbial Resistance of Rifaximin in Hepatic Encephalopathy
Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Aims and Objectives: To determine the safety and efficacy of rifaximin plus lactulose as
secondary prophylaxis of HE compared to lactulose alone. To evaluate the effect of long-term
administration of rifaximin on development of resistant mutants and investigating its
correlation with its efficacy.
Methods: An open label parallel, prospective interventional study was conducted. One hundred
patients experienced at least one attack of hepatic encephalopathy were included in the
study. Patients were randomly allocated either to receive rifaximin plus lactulose or
lactulose alone for 6 months. Conn score, Model of End stage Liver Disease (MELD) score,
asterixis grade, complete blood count (CBC), liver function tests, kidney function tests,
urine and stool analysis and abdominal ultrasonography were compared in both groups. The
primary efficacy endpoint was the time to the first breakthrough. The secondary efficacy
endpoint was the time to the first hospitalization involving HE. Safety assessment was done
by reporting any adverse events, serious adverse events and by repeating biochemical
evaluation every 2 weeks. Determination of the minimum inhibitory concentration (MIC) of
rifaximin for lactose fermenter isolates was done for the entire patients before starting
treatment and at the end of treatment.
Phase:
Phase 4
Details
Lead Sponsor:
National Hepatology & Tropical Medicine Research Institute