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To compare the efficacy of antibiotic treatment in spontaneous bacterial peritonitis in children with idiopathic nephrotic syndrome

Comparison of efficacy of short course versus usual course antibiotic treatment of spontaneous bacterial peritonitis in children with nephrotic syndrome aged 3 to 14 years â?? an open labelled randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032104
Enrollment
50
Registered
2021-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality

Interventions

Intervention1: Ceftriaxone: Intravenous Ceftraixone 75mg/kg/day in two divided doses. Long course (7 days) antibiotic treatment of spontaneous bacterial peritonitis in children with nephrotic syndrome

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To compare the following in both arms at the end of the treatment period - 1. The percentage of bacteriological cure 2. Ascitic fluid neutrophil response at different time points (at admission, at 72 hours if no clinical response and at the time of discharge) 3. Need for additional antibiotic treatment because of microbiological resistance/clinical non-response Timepoint: 5 days and 7 days—

Countries

India

Contacts

Public ContactLesa Dawman

PGIMER, Chandigarh

lesadawman@gmail.com9971957223

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026