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 - Anyone
   


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 [vrmasaumya@gmail.com].
   


6. For how long will this data be available start date provided 14-09-2026 and end date provided 14-09-2028?
   Response - Immediately following publication. No end date.
   


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

Urinary tract infection (UTI) is one of the most common bacterial infections in children that can      be associated with renal parenchymal injuries and late scars suggestive of Acute pyelonephritis (APN).

  DMSA scan known as gold standard for detecting Acute Pyelonephritis has lot of limitations. It is expensive, not easily available, has risks for radiation exposure and failure to distinguish between old and new scars unless follow-up scan is done. Gold Standard for diagnosis of UTI is urine culture which is time consuming and yield contamination if sample is not taken properly.

   The clinical diagnosis is also difficult, as both cystitis and acute pyelonephritis patients sometimes present with non-specific symptoms of UTI. Delay in diagnosis eventually leads to delay in treatment causing more damages to renal parenchyma; or outpatient abuse of unnecessary antibiotics which can lead to subsequent development of antibiotic resistance.

D-dimer and PCT level can be determined by venous blood samples that is generally available in all hospitals, therefore we sought to use them as an inflammatory marker in UTI for early diagnosis of Acute pyelonephritis.

  PCT is a precursor of calcitonin, with negligible blood levels under normal circumstances which appears in blood in few hours after inflammation, that could determine early renal parenchymal injury and helps to diagnose and treat children in best time possible to prevent renal scar. A meta-analysis of 18 studies concluded that PCT>= 1.0ng/ml has highest diagnostic performance for differentiation of acute pyelonephritis from cystitis. Studies also showed that PCT can also predict UTI severity.

  D-dimer is a fibrin degradation product which represents the activation of coagulation system which can increase in conditions involving inflammation. Studies have reported its significance as an inflammatory marker of UTI.