| 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
|
|
|
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
|
|
|
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
|
|
|
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 OUTCOME1. 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
|