Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

NCT ID: NCT02388035

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-06-30

Brief Summary

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Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. It is considered to be one of the first choice antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms have been increasingly reported especially to cefotaxime and its effect on the clinical outcome in treating SBP.

Detailed Description

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Conditions

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Spontaneous Bacterial Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBP-group 1

Spontanous bacterial peritonitis

Group Type EXPERIMENTAL

Cefotaxime

Intervention Type DRUG

CNNA-group 2

Culture negative neutrocytic ascites

Group Type EXPERIMENTAL

Cefotaxime

Intervention Type DRUG

MNBA-group 3

monomicrobial non-neutrocytic ascites

Group Type EXPERIMENTAL

Cefotaxime

Intervention Type DRUG

group 4

no evidence of ascitic fluid infection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cefotaxime

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection

Exclusion Criteria

* Patients were excluded if they received antibiotics ten days prior to the hospital admission or there is evidence of secondary bacterial peritonitis, tuberculous peritonitis, malignant ascites or ascites due to other causes e.g. cardiac or renal diseases
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Ahmed Ali Elbaz

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr Ahmed Ali Elbaz

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nasser institute

Cairo, Shubra, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HHAEREDS-2015

Identifier Type: -

Identifier Source: org_study_id

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