Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Tanta University

Status and phase: Enrolling; Phase 3

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: Itopride; Drug: Norfloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT04161768

SBP Management

Details and patient eligibility

About

Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Full description

Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• cirrhotic patients with ascites who had previous episodes of SBP.

Exclusion criteria

• 1. Allergy or contraindication for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. Pregnant and lactating women.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Norfloxacin

Active Comparator group

Description:

Norfloxacin 400 mg daily

Treatment:

Drug: Norfloxacin

Norfloxacin and Itopride

Experimental group

Description:

Norfloxacin 400 mg daily and Itopride 50 mg three times daily.

Treatment:

Drug: Norfloxacin

Drug: Itopride