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
|
|
Primary Sponsor
|
Name |
PGIMER Chandigarh |
Address |
Department of Pediatrics, PGIMER, Chandigarh |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lesadawman@gmail.com].
- 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.
- 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. |