To compare the efficacy of antibiotic treatment in spontaneous bacterial peritonitis in children with idiopathic nephrotic syndrome
- Conditions
- Nephrotic syndrome with minor glomerular abnormality,
- Registration Number
- CTRI/2021/03/032104
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Nephrotic syndrome is a common problem in children with good prognosis, but the disease course is associated with significant morbidity due to multiple relapses and its associated complications. Almost 95% case of nephrotic syndrome are primary with no identified cause. Approximately 85 – 90% of children with idiopathic nephrotic syndrome are steroid responsive while 10 – 15 % are partial or steroid resistant nephrotic syndrome. Infections remain an important cause of mortality and morbidity in children with nephrotic syndrome. It triggers the onset of disease or relapses and may also be responsible for a poor response to steroid therapy. Infections can lead to repeated relapses, poor response to steroid therapy and prolonged hospitalization. Spontaneous bacterial peritonitis is a serious complication of nephrotic syndrome with an incidence of 2-6%, and overwhelming infection carries a mortality risk of 1 – 5%. It usually occurs within the first 2 years of diagnosis of nephrotic syndrome. Low serum albumin, ascites, and an impaired immune system predispose to peritonitis and most often it is multifactorial in origin. Majority of peritonitis are caused by encapsulated gram positive organisms, particularly streptococcus pneumoniae, but may also be caused by gram-negative organisms. We plan to do a pilot study, which will be an open labelled randomized control trial, on the efficacy, safety and cost of short course (5days) versus usual course (7days) antibiotic treatment of spontaneous bacterial peritonitis in children with nephrotic syndrome aged 3 to 14 years. It will be an RCT with one short course and one long course antibiotic regimen, which will be compared head to head in this study. This will help us in better understanding of the optimum duration of antibiotic needed to treat SBP and help in the decision making of further treatment plan. There is limited data on antibiotic duration for SBP in children with nephrotic syndrome as well as its correlation with the clinical outcome, hence the importance of this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
- 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.
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. 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 - 1.The percentage of bacteriological cure
Trial Locations
- Locations (1)
PGIMER, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
PGIMER, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDr Lesa DawmanPrincipal investigator9971957223lesadawman@gmail.com