| CTRI Number |
CTRI/2024/09/073598 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of (1,3)-β-D-glucan kit to detect blood fungal infections early in premature babies |
|
Scientific Title of Study
|
Role of (1,3)-β-D-glucan in early diagnosis of invasive fungal infections in preterm neonates admitted in neonatal intensive care unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DURGESH KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of Pediatrics
Uttar Pradesh University of Medical Sciences, Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09917144512 |
| Fax |
|
| Email |
drdurgeshk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DURGESH KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of Pediatrics
Uttar Pradesh University of Medical Sciences, Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09917144512 |
| Fax |
|
| Email |
drdurgeshk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DURGESH KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of Pediatrics
Uttar Pradesh University of Medical Sciences, Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09917144512 |
| Fax |
|
| Email |
drdurgeshk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research cell, Uttar Pradesh University of Mesdical
Sciences, Saifai, Etawah, Uttar Pradesh, India -206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Saifai, Etawah, Uttar Pradesh, India - 206130 |
| 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 Durgesh Kumar |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
Neonatal Intensive Care Unit and Sick Newborn Unit, Department of Pediatrics
Etawah
UTTAR PRADESH |
09917144512
drdurgeshk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P399||Infection specific to the perinatal period, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Male |
| Details |
Ptreterm neonates having suspected fungal sepsis |
|
| ExclusionCriteria |
| Details |
Preterm neonates already on antibiotics before admission |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic efficacy of (1,3)-β-D-glucan will be compared with blood culture for the diagnosis of invasive fungal infections in preterm neonates. |
Any time when fungal infections will be suspected during hospitalization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diagnostic efficacy of one three Beta D Glucan in preterm neonate |
during fungal infections |
|
|
Target Sample Size
|
Total Sample Size="553"
Sample Size from India="553"
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)
|
20/09/2024 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Rationale: Invasive fungal infections are the important
contributor to neonatal morbidity and mortality. Immunocompromised hosts, such
as premature infants, with invasive candidiasis can suffer from severe and
life-threatening illness. The incidence of invasive candidiasis in extremely
low birth weight infants varies by neonatal intensive care unit (NICU) from 10%
to 28%. The most commonly reported risk factors for invasive fungal infection
are prematurity, low birth weight, major congenital malformations, exposure to
broad spectrum antibiotics, central venous catheters, delayed enteral feeds,
prolonged parenteral nutrition, endotracheal intubation, and longer NICU stay.
Invasive fungal infection manifestations are non-specific, and blood culture is
considered the gold standard for its diagnosis. Unfortunately, the results of
blood cultures are usually obtained after 48 h or more. More-over, there are
high rate of false negative results with cultures. Therefore, new tools are
required for early diagnosis of invasive fungal infection in neonates.
1,3-β-D-Glucan (BDG) is a component of the outer cell wall of fungi, including
Candida spp., and it is released into the blood stream during invasive fungal
infection. To date, only few trials have been conducted regarding performance
of 1,3-β-D-Glucan as diagnostic marker of invasive fungal infection in Indian
neonates. Novelty: Culture-based diagnostic media have a recognized and clear role in the
diagnosis of invasive fungal infections but their deficiencies are also known,
particularly in sensitivity and also in speed. Therefore, it is essential to
implement the diagnosis of invasive fungal infections with non-culture-based techniques.
One of the biomarkers targeting specific Candida fungal components is
1,3-β-D-glucan (BDG) which is a constituent of the cell wall of many fungi and
can be detected in the serum during invasive fungal infection. However, there is paucity of data regarding
the performance of this technique in Indian neonates. Objectives: To evaluate the performances of (1,3)-β-D-glucan for the diagnosis of
invasive fungal infections and to compare its diagnostic value with blood
culture for the diagnosis of invasive fungal infections in preterm neonates
admitted in neonatal intensive care unit. Methods: Preterm neonates
admitted in NICU having suspected fungal sepsis (birth weight <1250 g,
history of broad-spectrum antibiotic or a third-generation cephalosporin
coverage > 7 days, platelet count <150,000/µL, enteral feeding by 3 days
of life, use of systemic steroids > 3 days, invasive mechanical ventilation
> 3 days, total parenteral nutrition >5 days, Central catheter, and
length of NICU stay >7 days) will be enrolled in the
study.
Two
samples of whole blood will be collected from each neonate. One
sample for blood culture transported to microbiology department for
automated BACTEC culture and clinical isolates of Candida spp. will be obtained
from blood culture. Serum will be separated from second sample by centrifugation
and the BDG assay will be done immediately or sub-pack for cryopreservation at
-20°C or -80°C. Measured outcomes: Diagnostic efficacy
of (1,3)-β-D-glucan will be compared with blood culture for the diagnosis of
invasive fungal infections in preterm neonates admitted in neonatal intensive
care. |