Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

Dr Ahmed Ali Elbaz

Status: Completed

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: Cefotaxime

Study type: Interventional

Funder types: Other

Identifiers

NCT02388035

HHAEREDS-2015

Details and patient eligibility

About

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.

Enrollment: 254 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

254 participants in 4 patient groups

SBP-group 1

Experimental group

Description:

Spontanous bacterial peritonitis

Treatment:

Drug: Cefotaxime

CNNA-group 2

Experimental group

Description:

Culture negative neutrocytic ascites

Treatment:

Drug: Cefotaxime

MNBA-group 3

Experimental group

Description:

monomicrobial non-neutrocytic ascites

Treatment:

Drug: Cefotaxime

group 4

No Intervention group

Description:

no evidence of ascitic fluid infection