To compare the efficacy of antibiotic treatment in spontaneous bacterial peritonitis in children with idiopathic nephrotic syndrome
Not Applicable
- Conditions
- Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
- Registration Number
- CTRI/2021/03/032104
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children with idiopathic nephrotic syndrome aged 1 to 14 years presenting to Pediatric OPD/ Emergency/ Ward with clinical symptoms of spontaneous bacterial peritonitis.
2.Ascitic fluid cell count >= 100 leucocytes/mm3with >50% neutrophils with clinical symptoms suggestive of SBP (i.e. abdominal pain, tenderness, distension, diarrhoea, or vomiting)
3.Caregivers giving informed written consent
Exclusion Criteria
1.Hypersensitivity to cephalosporins/penicillin
2.Current treatment with antibiotics or history of treatment with antibiotics prior to 3 days of admission to hospital
3.Suspected meningitis or presence of septic shock or severe sepsis with MODS
4.Caregiver not providing informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion with resolution of clinical symptoms of SBP after 5 days and 7 days of IV antibiotics treatment in both arms. It will be determined by reviewing the clinical symptoms and peritoneal fluid analysis at admission and at the time of completion of treatment duration.Timepoint: 5 days and 7 days or at the time of discharge
- Secondary Outcome Measures
Name Time Method To compare the following in both arms at the end of the treatment period - <br/ ><br>1.The percentage of bacteriological cure <br/ ><br>2.Ascitic fluid neutrophil response at different time points (at admission, at 72 hours if no clinical response and at the time of discharge) <br/ ><br>3.Need for additional antibiotic treatment because of microbiological resistance/clinical non-response <br/ ><br>Timepoint: 5 days and 7 days