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Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02388035
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : June 4, 2015
Information provided by (Responsible Party):
Dr Ahmed Ali Elbaz, Nasser Institute For Research and Treatment

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.

Condition or disease Intervention/treatment Phase
Spontaneous Bacterial Peritonitis Drug: Cefotaxime Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis
Study Start Date : March 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cefotaxime

Arm Intervention/treatment
Experimental: SBP-group 1
Spontanous bacterial peritonitis
Drug: Cefotaxime
Experimental: CNNA-group 2
Culture negative neutrocytic ascites
Drug: Cefotaxime
Experimental: MNBA-group 3
monomicrobial non-neutrocytic ascites
Drug: Cefotaxime
No Intervention: group 4
no evidence of ascitic fluid infection

Primary Outcome Measures :
  1. Organisms detected with their antibiotics sensitivity [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02388035

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Nasser institute
Cairo, Shubra, Egypt
Sponsors and Collaborators
Dr Ahmed Ali Elbaz

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Responsible Party: Dr Ahmed Ali Elbaz, Dr, Nasser Institute For Research and Treatment Identifier: NCT02388035     History of Changes
Other Study ID Numbers: HHAEREDS-2015
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by Dr Ahmed Ali Elbaz, Nasser Institute For Research and Treatment:
profiles changes
effective antibiotics
Additional relevant MeSH terms:
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Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents