A Phase 3 interventional study of Rifaximin 550Mg Tab and Ciprofloxacin 750 MG in Spontaneous Bacterial Peritonitis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Ain Shams University · Phase 3, Interventional, and Prevention
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.
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;
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's enrollment of 80 is close to the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.
Drug: Rifaximin 550Mg Tab · Diagnostic Test: ascitic fluid sample
Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
Drug: Ciprofloxacin 750 MG · Diagnostic Test: ascitic fluid sample
group (1) received Rifaximin as 550 mg twice daily dosage for six months.
Also known as: gastrobiotic
group (2) received Ciprofloxacin 750 mg tab mg once weekly dosage for six months.
Also known as: Cipro
aspiration of ascitic fluid sample and analysis for differential cell count
Also known as: aspiration of ascitic fluid
The efficacy of Rifaximin as a prophylactic treatment for SBP.
comparison between Rifaximin and Ciprofloxacin when used as a prophylaxis for the recurrence of SBP.
Time frame: All patients of the two groups were followed up for 6 months.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rifaximin · Ciprofloxacin