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

T

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

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

Trial contacts and locations

1

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Central trial contact

Sherief Abd-Elsalam, ass. prof.; sherief abd-elsalam, ass. prof.

Data sourced from clinicaltrials.gov

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