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NCT02388035 Clinical Trial

Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

Spontaneous Bacterial Peritonitis Clinical Trial

Official title:
Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

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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Completed NCT02528097 - A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis N/A
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Completed NCT04153604 - Doxycycline for the Prevention of Spontaneous Bacterial Peritonitis
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Completed NCT05401721 - Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
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Recruiting NCT02759497 - Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis N/A
Completed NCT02608658 - Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites N/A
Completed NCT03163745 - Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis
Completed NCT04273373 - Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis. N/A
Active, not recruiting NCT04395365 - Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis Phase 3
Terminated NCT00570960 - Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis Phase 4
Recruiting NCT05422118 - Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis N/A