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CTRI Number  CTRI/2021/03/032104 [Registered on: 18/03/2021] Trial Registered Prospectively
Last Modified On: 17/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of antibiotic treatment in spontaneous bacterial peritonitis in children with idiopathic nephrotic syndrome 
Scientific Title of Study   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 – an open labelled randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hijam Kherojit 
Designation  Junior Resident 
Affiliation  PGIMER, Chandigarh 
Address  Department of Pediatrics, Advanced Pediatrics Centre, PGIMER, Chandigarh - 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7629022284  
Fax    
Email  kherojitdr2017@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Lesa Dawman 
Designation  Assistant Professor 
Affiliation  PGIMER, Chandigarh 
Address  Room No. 5120, 5A, Advanced Pediatrics Centre, PGIMER, Chandigarh - 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9971957223  
Fax    
Email  lesadawman@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Lesa Dawman 
Designation  Assistant Professor 
Affiliation  PGIMER, Chandigarh 
Address  Room No. 5120, 5A, Advanced Pediatrics Centre, PGIMER, Chandigarh - 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9971957223  
Fax    
Email  lesadawman@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Chandigarh 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  Department of Pediatrics, PGIMER, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lesa Dawman  PGIMER, Chandigarh  Room No. 5120, 5A, Pediatric Nephrology Unit, Department of Pediatrics, Advanced Pediatrics Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH 
9971957223

lesadawman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC PGIMER Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 
Comparator Agent  Ceftriaxone  Intravenous Ceftraixone 75mg/kg/day in two divided doses. Short course (5days) antibiotic treatment of spontaneous bacterial peritonitis in children with nephrotic syndrome 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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
 
5 days and 7 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [lesadawman@gmail.com].

  6. For how long will this data be available start date provided 22-05-2021 and end date provided 22-01-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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.

 
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