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Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

Primary Purpose

Spontaneous Bacterial Peritonitis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Cefotaxime

About this trial

This is an interventional treatment trial for Spontaneous Bacterial Peritonitis focused on measuring profiles changes, microorganisms, cefotaxime, SBP, Egyptian, effective antibiotics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nasser institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

SBP-group 1

CNNA-group 2

MNBA-group 3

group 4

Arm Description

Spontanous bacterial peritonitis

Culture negative neutrocytic ascites

monomicrobial non-neutrocytic ascites

no evidence of ascitic fluid infection

Outcomes

Primary Outcome Measures

Organisms detected with their antibiotics sensitivity

Secondary Outcome Measures

Full Information

NCT ID

NCT02388035

First Posted

March 9, 2015

Last Updated

June 3, 2015

Sponsor

Dr Ahmed Ali Elbaz

1. Study Identification

Unique Protocol Identification Number

NCT02388035

Brief Title

Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

Official Title

Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr Ahmed Ali Elbaz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spontaneous Bacterial Peritonitis

Keywords

profiles changes, microorganisms, cefotaxime, SBP, Egyptian, effective antibiotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

254 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SBP-group 1

Arm Type

Experimental

Arm Description

Spontanous bacterial peritonitis

Arm Title

CNNA-group 2

Arm Type

Experimental

Arm Description

Culture negative neutrocytic ascites

Arm Title

MNBA-group 3

Arm Type

Experimental

Arm Description

monomicrobial non-neutrocytic ascites

Arm Title

group 4

Arm Type

No Intervention

Arm Description

no evidence of ascitic fluid infection

Intervention Type

Drug

Intervention Name(s)

Cefotaxime

Primary Outcome Measure Information:

Title

Organisms detected with their antibiotics sensitivity

Time Frame

8 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Nasser institute

City

Cairo

State/Province

Shubra

Country

Egypt

12. IPD Sharing Statement

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Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

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