Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

Tanta University

Status and phase: Unknown; Phase 3

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: Norfloxacin; Drug: Nitazoxanide

Study type: Interventional

Funder types: Other

Identifiers

NCT04746937

NTZ in Prevention of SBP

Details and patient eligibility

About

the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Full description

due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of NTZ as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis.

Exclusion criteria

• Exclusion criteria included active gastrointestinal bleeding Hepatic encephalopathy (>grade 2) Hepatocellular carcinoma (HCC) or other malignancies Allergy to used medications.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

They will receive standard therapy plus placebo

Treatment:

Drug: Norfloxacin

Nitazoxanide Group

Active Comparator group

Description:

They will receive standard therapy plus nitazoxanide

Treatment:

Drug: Norfloxacin

Drug: Nitazoxanide