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CTRI Number  CTRI/2026/03/105869 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 16/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Occurrence of Candida fungus in the urine of ICU patients 
Scientific Title of Study   Incidence of candiduria and its outcomes in ICU patients- a single centre, prospective, observational study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prishel Mariam Prasad  
Designation  Senior Resident, Department of critical care medicine, St Johns medical college and hospital  
Affiliation  St. Johns National Academy of Health Sciences 
Address  St. Johns National Academy of Health Sciences, Sarjapur Road, Bangalore - 560034, Karnataka, India.

Bangalore
KARNATAKA
560034
India 
Phone  8590117421  
Fax    
Email  prishel.mariam@stjohns.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhuvana Krishna  
Designation  Professor and Head Of The Department, Department of critical care medicine  
Affiliation  St. Johns National Academy of Health Sciences 
Address  St. Johns National Academy of Health Sciences, Sarjapur Road, Bangalore - 560034, Karnataka, India.

Bangalore
KARNATAKA
560034
India 
Phone  9945693221  
Fax    
Email  bhuvana.11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prishel Mariam Prasad  
Designation  Senior Resident, Department of critical care medicine, St Johns medical college and hospital  
Affiliation  St. Johns National Academy of Health Sciences 
Address  St. Johns National Academy of Health Sciences, Sarjapur Road, Bangalore - 560034, Karnataka, India.

Bangalore
KARNATAKA
560034
India 
Phone  8590117421  
Fax    
Email  prishel.mariam@stjohns.in  
 
Source of Monetary or Material Support  
Department of critical care medicine St Johns medical college and hospital Bengaluru - 560034 
nil 
 
Primary Sponsor  
Name  Dr Prishel Mariam Prasad  
Address  Department of critical care medicine St. Johns National Academy of Health Sciences, Sarjapur Road, Bangalore - 560034, Karnataka, India.  
Type of Sponsor  Other [Self] 
 
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 Prishel Mariam Prasad   St. Johns National Academy of Health Sciences  Department of critical care medicine, Sarjapur Road, Bangalore - 560034, Karnataka, India.
Bangalore
KARNATAKA 		 08590117421

prishel.mariam@stjohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee , St Johns medical college and hospital, Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B379||Candidiasis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients greater than or equal to 18 years of age admitted to ICU.
2.Patients with urinary catheter greater than or equal to 48 hours of ICU admission.
3.Urine culture samples sent after greater than or equal to 48 hours of ICU admission only
 
 
ExclusionCriteria 
Details  1. Patients who are already started on antifungal therapy at ICU admission.
2. Patients with all stages of CKD
3. Patients who are already initiated on RRT
4. Patients without urinary catheter
5. Patients with pre existing candiduria
6. Pregnant women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the incidence of candiduria in ICU patients .

 		 Over a period of one year

 
 
Secondary Outcome  
Outcome  TimePoints 
2.To determine the incidence of Acute kidney injury in ICU patients with candiduria
3.To estimate the incidence of need for renal replacement therapy in ICU patients with candiduria
4.To find the percentage of 90 day hospital mortality in ICU patients with candiduria
5.To find the mean ICU length of stay in ICU patients with candiduria

 		 1 year 
 
Target Sample Size   Total Sample Size="263"
Sample Size from India="263" 
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)   15/03/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·         Candiduria  is commonly encountered especially in ICU patients.

·         The patients who are susceptible for candiduria are the elderly, females, diabetic patients with indwelling urinary devices, those on antibiotics and those who have had prior surgical procedures.

·         The decision to treat or not treat candiduria is important since it may indicate an innocuous colonization in some cases whereas in others it may also be a marker of urinary tract infection.

·         Also,candiduria is a well-established risk factor for invasive candidiasis which in turn is associated with significant morbidity, mortality and cost in ICU patients. 

·         Acute kidney injury (AKI) in the context of candiduria is primarily driven by direct fungal invasion and obstruction, with additional contributions from inflammation and immune dysregulation.

·         Candida can ascend from the lower urinary tract or seed the kidneys via hematogenous spread (candidemia). The kidneys are particularly susceptible due to their blood flow and filtration function, which allows for deposition and proliferation of fungal elements within renal tissue. Hence, AKI in candiduria is multifactorial, involving direct fungal invasion, obstruction from fungal balls or necrotic tissue, and dysregulated inflammation leading to tubular and papillary damage.Thus, early recognition and intervention are crucial to prevent irreversible renal injury and renal replacement therapy.Current guidelines only recommend the elimination of predisposing factors, such as indwelling bladder catheters ,whenever feasible for asymptomatic candiduria.Treatment with antifungal agents is not recommended unless the patient belongs to a group at high risk for dissemination such as neutropenic patients and very low-birth-weight infants.Since there are few guidelines to follow, physicians tend to make decisions by personal experience in many cases in clinical practice and presently there are very few studies that have been conducted in ICU to study the effect of candiduria on AKI and need for renal replacement therapy.

·         Hence, it becomes necessary to study regarding the incidence of candiduria in ICU patients and its outcomes in terms of incidence of acute kidney injury, need for renal replacement therapy, length of ICU stay and hospital mortality.


 
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