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临床试验/CTRI/2025/09/094071
CTRI/2025/09/094071尚未招募不适用

ASSOCIATION OF CANDIDA SPP. COLONIZATION WITH PATIENT OUTCOME IN PAEDIATRIC INTENSIVE CARE UNIT PATIENTS

Department Of Microbiology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.Proportion of patients colonized by Candida spp. including Candida auris.

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 15.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • Patients transferred or discharged before 3 days of admissions.

结局指标

主要结局

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

时间窗: 1 year

2.Antifungal susceptibility profiles of the Candida species isolates.

时间窗: 1 year

3.Patient outcomes:

时间窗: 1 year

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

时间窗: 1 year

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

时间窗: 1 year

c.Incidence of acquired invasive Candida infections

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Department Of Microbiology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anandita

Maulana Azad Medical College

研究点 (1)

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