CompletedNCT02388035Updated Jun 4, 2015

Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis

An interventional study of Cefotaxime in Spontaneous Bacterial Peritonitis, sponsored by Dr Ahmed Ali Elbaz. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2015-06-04.

Sponsored by Dr Ahmed Ali Elbaz · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 254
Allocation: Randomized
Sex: All

Study 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.

Conditions studied

Spontaneous Bacterial Peritonitis

Browse trials for

Peritonitis 185

Keywords

profiles changes
microorganisms
cefotaxime
SBP
Egyptian
effective antibiotics

In context

Peritonitis

185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.

This study's enrollment of 254 is above the median of 95 across 118 interventional studies indexed under Peritonitis.

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Lead sponsor

This is the only study on the registry with Dr Ahmed Ali Elbaz as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 254 participants (actual)

Study arms

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

Interventions

DrugCefotaxime

What researchers measure

Primary outcomes

Organisms detected with their antibiotics sensitivity
Time frame: 8 months

Study locations

1 site

Nasser institute
Cairo, Shubra, Egypt

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02388035
Lead sponsor: Dr Ahmed Ali Elbaz
Responsible party: Dr Ahmed Ali Elbaz (Dr, Nasser Institute For Research and Treatment) — Sponsor-investigator
First posted: Mar 13, 2015
Start date: Mar 2015
Primary completion: May 2015
Completion: Jun 2015
Last update: Jun 4, 2015

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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