Clinical trial NCT06234046: Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin
Official title: Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled trial was performed on two groups of Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack, group (1) included 40 patients were administered Rifaximin as 550 mg twice daily dosage for six months and group (2)included 40 patients were administered Ciprofloxacin as 750 mg once weekly dose for 6 months. All patients of the two groups were followed up for recurrence of SBP for 6 months.
Primary purpose: PREVENTION

Brief summary: The goal of this Randomized controlled trial is to assessment the efficacy of Rifaximin as a prophylaxis of SBP in comparison with ciprofloxacin in Egyptian patients.

This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as; Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period and group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.

All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.

Detailed description: This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as;

* Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.
* Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.

The included cases were collected from hepatology outpatient clinic and inpatient department at Ain shams University hospital between May 2023 and November 2023 after the scientific ethical committee approval. A written consent was obtained from the included cases.

Cases with metastatic HCC, patients with drug allergy from Ciprofloxacin or Rifaximin, those having ascites secondary to other causes rather than liver cirrhosis, those having gastroenterology malignancy, patients on immunotherapy, and HIV patients were all excluded from the trial. Before starting the trial, the all cases were diagnosed as SBP with ascitic fluid sample with polymorphonuclear cell count more than 250 cells /µL and received medical treatment of SBP according to EASL guidelines for treatment of SBP.

All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.

All included patients went through a comprehensive medical history, full physical assessment as well as full laboratory examination including; CBC, liver profile (ALT, AST, ALP, GGT, total \& direct bilirubin, serum albumin, serum total proteins), kidney function tests (S.creat, BUN), ascitic fluid sample was taken from every patients at the starting of the trial to make sure the recovery from the previous SBP attack (AFS1) and another sample was taken once the patient was suspected to have another attack of SBP or after 6 months of treatment (AFS2). The ascitic samples were subjected to analysis of the differential cell count and measurement of ascitic albumin, glucose, total proteins and LDH, culture and sensitivity were assessed. The Child-Pugh's score were assessed, and pelvi-abdominal ultrasound were done for all patients.

Eligibility criteria: Inclusion Criteria:

* cirrhotic liver disease patients with ascites just recovered from SBP attack.
* Must be able to swallow tablets

Exclusion Criteria:

* Cases with metastatic HCC.
* patients with drug allergy from Ciprofloxacin or Rifaximin.
* those having ascites secondary to other causes rather than liver cirrhosis.
* those having gastroenterology malignancy.
* patients on immunotherapy.
* HIV patients.

Primary outcomes:
measure: The efficacy of Rifaximin as a prophylactic treatment for SBP.
timeFrame: All patients of the two groups were followed up for 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mostafa Elfors
Study officials:
References: