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CTRI Number  CTRI/2025/09/094071 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Studying the Link Between Candida Infection and Recovery in Children Admitted to the ICU" 
Scientific Title of Study   ASSOCIATION OF CANDIDA SPP. COLONIZATION WITH PATIENT OUTCOME IN PAEDIATRIC INTENSIVE CARE UNIT PATIENTS 
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 Anandita 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Department of Microbiology, Maulana Azad Medical College, New Delhi

New Delhi
DELHI
110002
India 
Phone  9625985133  
Fax    
Email  drananditavishwakarma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Oves Siddiqui 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Microbiology, Maulana Azad Medical College, New Delhi

New Delhi
DELHI
110002
India 
Phone  9990766802  
Fax    
Email  oves16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anandita 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Department of Microbiology, Maulana Azad Medical College, New Delhi

New Delhi
DELHI
110002
India 
Phone  9625985133  
Fax    
Email  drananditavishwakarma@gmail.com  
 
Source of Monetary or Material Support  
Department of Microbiology, Maulana Azad Medical College New Delhi 110002 
 
Primary Sponsor  
Name  Department Of Microbiology 
Address  Department of Microbiology, Maulana Azad Medical, New Delhi 
Type of Sponsor  Government medical college 
 
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 Anandita  Lok Nayak Hospital  Paediatric Intensive Care Unit , Lok Nayak Hospital, Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, near Delhi Gate,Balmiki Basti, New Delhi, Delhi, 110002
New Delhi
DELHI 
9625985133

drananditavishwakarma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B372||Candidiasis of skin and nail, (2) ICD-10 Condition: B379||Candidiasis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  15.00 Year(s)
Gender  Both 
Details  All the patients admitted in Paediatric Intensive Care Unit, MAMC 
 
ExclusionCriteria 
Details  Patients transferred or discharged before 3 days of admissions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Proportion of patients colonized by Candida spp. including Candida auris.
2.Antifungal susceptibility profiles of the Candida species isolates.
3.Patient outcomes:
a.Mean duration of ICU stay (number of days admitted)
b.Proportion of patients with Clinical outcome categorized as: cured, improved, worsened and deceased.
c.Incidence of acquired invasive Candida infections 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/09/2025 
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  

Candida spp. are commensal yeasts that can be found in up to 60% of healthy people and are a normal component of the human skin and gut microbiome.1 Fungal infections, particularly those caused by Candida spp. have emerged as a significant threat in critically ill patients, especially within paediatric intensive care units (PICUs). Among the diverse fungal pathogens, Candida albicans remains the most prevalent opportunistic species, known for its ability to colonize mucosal surfaces and transition into invasive infection under immunocompromised conditions.2 

Recent researches have emphasized the high colonization rates of Candida spp. among ICU patients, and how closely it’s tied to patient outcomes. In many cases, colonization is the first step before the infection spreads to the bloodstream—something that can lead to serious complications, longer hospital stays, and even higher chances of death. While Candida albicans is still the most common troublemaker, other species like C. glabrata, C. tropicalis, and C. parapsilosis are becoming more frequent and bring their own challenges, especially when it comes to antifungal resistance.3 

The World Health Organization (2022) has recognized Candida albicans and other Candida spp. as priority fungal pathogens, calling for urgent public health action and research investment.4 This prioritization reflects the growing burden of Candida-related morbidity and the critical knowledge gaps in understanding its pathogenesis, especially in paediatric intensive care environments. A meta-analysis by Thomas-Rüddel et al.5 in 2022 identified several risk factors for invasive Candida infection in critically ill patients, including broad spectrum antibiotic therapy, blood transfusion, candida colonization, central venous catheter uses and parenteral nutrition—all common in PICU settings.

This study has been planned to estimate rate of different Candida spp. colonization with special reference to Candida auris and its association with patient’s outcome in Paediatrics ICU. Antifungal susceptibility testing will be performed on Candida species isolated from patients.

 AIM – To study the association of Candida spp. colonization with patient’s outcome in Paediatric Intensive Care Unit.

 

Primary Objectives:

To estimate the rate of Candida spp. colonization in patients admitted to the Paediatric Intensive Care Unit.

 

Secondary Objective:

1. To estimate the magnitude of Candida auris colonization in Paediatric Intensive Care Unit patients.

2. To correlate the outcome of patients with colonization of Candida spp.

 

 INCLUSION CRITERIA

All the patients admitted in Paediatric Intensive Care Unit, MAMC.

 EXCLUSION CRITERIA

Patients transferred or discharged before 3 days of admissions.

STUDY OUTCOME

1. Proportion of patients colonized by Candida spp. including Candida auris.

2. Antifungal susceptibility profiles of the Candida species isolates.

3. Patient outcomes:

a. Mean duration of ICU stay (number of days admitted)

b. Proportion of patients with Clinical outcome categorized as: cured, improved, worsened and deceased.  

c. Incidence of acquired invasive Candida infections


 
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