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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02388035
Other study ID # HHAEREDS-2015
Secondary ID
Status Completed
Phase N/A
First received March 9, 2015
Last updated June 3, 2015
Start date March 2015
Est. completion date June 2015

Study information

Verified date June 2015
Source Nasser Institute For Research and Treatment
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 254
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Cefotaxime


Locations

Country Name City State
Egypt Nasser institute Cairo Shubra

Sponsors (1)

Lead Sponsor Collaborator
Dr Ahmed Ali Elbaz

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Organisms detected with their antibiotics sensitivity 8 months Yes
See also
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