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CTRI Number  CTRI/2021/07/035281 [Registered on: 30/07/2021] Trial Registered Prospectively
Last Modified On: 23/11/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational Study of Patients with Mucormycosis 
Study Design  Other 
Public Title of Study   Mucormycosis Study 
Scientific Title of Study   Evaluating the Use of Blood based Real Time Polymerase Chain Reaction Testing for Early Detection and Monitoring of Mucormycosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EC/Gen/2021-2/DA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dadasaheb Akolkar 
Designation  Director- Research and Innovations 
Affiliation  Datar Cancer Genetics Private Limited 
Address  Dr. Dadasabeb Akolkar Department - Research and Innovations Dartar Cancer Genetics F-8, D Road, Ambad, MIDC, Nashik - 422010, Maharashtra, India

Nashik
MAHARASHTRA
422010
India 
Phone  02536690804  
Fax    
Email  dadasaheb.akolkar@datarpgx.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dadasaheb Akolkar 
Designation  Director- Research and Innovations 
Affiliation  Datar Cancer Genetics Private Limited 
Address  Dr. Dadasabeb Akolkar Department - Research and Innovations Dartar Cancer Genetics F-8, D Road, Ambad, MIDC, Nashik - 422010, Maharashtra, India

Nashik
MAHARASHTRA
422010
India 
Phone  02536690804  
Fax    
Email  dadasaheb.akolkar@datarpgx.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashwini Ghaisas 
Designation  Director – Application 
Affiliation  Datar Cancer Genetics Private Limited 
Address  Dr. Ashwini Ghaisas Department - Application Dartar Cancer Genetics F-8, D Road, Ambad, MIDC, Nashik - 422010, Maharashtra, India

Nashik
MAHARASHTRA
422010
India 
Phone  02536690804  
Fax    
Email  anghaisas@datarpgx.com  
 
Source of Monetary or Material Support  
Datar Cancer Genetics  
 
Primary Sponsor  
Name  Datar Cancer Genetics Private Limited 
Address  F-8, D Road, Ambad, MIDC, Nashik, Maharashtra 422010 
Type of Sponsor  Other [Private Molecular Laboratory] 
 
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 Dadasaheb Akolkar  Datar Cancer Genetics Private Limited  Datar Cancer Genetics Private Limited COVID Laboratory F-7, D Road, Ambad, MIDC, Nashik - 422010, Maharashtra, India
Nashik
MAHARASHTRA 
02536690804

dadasaheb.akolkar@datarpgx.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datar Cancer Genetics Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • High risk patients (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressor, recipients of allogeneic Hematopoietic stem-cell transplantation (HSCT), or inherited severe immunodeficiency)
• Patients with other predisposing factors of invasive mould disease (Uncontrolled blood sugars, known diabetic on steroids , Acquired immunodeficiency syndrome (AIDS), haematological malignancies or solid tumours, prolonged Intensive Care Unit, or hospital stay abnormal D Dimer test).
• Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions, including patients referred from other centers.
 
 
ExclusionCriteria 
Details  • Presence of any medical condition that would not allow collection of blood samples for the Real-time polymerase chain reaction test.
• History of documented, successfully treated, prior Mucormycosis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To diagnose early Mucormycosis and assess the sensitivity and specificity of the test  Date of first enrollment - 15th June 2021
Target to achieve sample size - In three months
Study completion - As per study criteria  
 
Secondary Outcome  
Outcome  TimePoints 
Any other incidental or significant observation  Six months from completion of study 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/08/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Mucormycosis is a rare invasive fungal infection with exceedingly high mortality and few therapeutic options. The disease is caused by Mucorales, which is a large group of species within the order of zygomycetes1,2.

Amidst the catastrophe of the second wave of the Coronavirus, the challenge of black fungus is constantly increasing. Many cases of this rare fungal infection have been reported in different parts of the country. Deaths have also been recorded in many places. In Maharashtra alone, 90 people have lost their lives due to black fungus. Every day new cases are coming up in other states including Delhi, Rajasthan, Madhya Pradesh. Rajasthan has even declared black fungus as an epidemic1.

Which patients have the highest risk?

·       Patients with uncontrolled diabetes, diabetic ketoacidosis, and diabetics on steroids or tocilizumab

·       Patients on immune-suppressants or anti-cancer treatment, and patients with chronic debilitating illness

·       Patients on high dose steroids for longer duration or tocilizumab and clinical evidence of thromboembolic episodes like abnormal D’Dimer test.

·       Severe Covid cases

·       Patients on oxygen support – nasal springs, by mask, or on a ventilator.

Recently, molecular techniques have offered an additional opportunity to improve the diagnostic sensitivity3. PCR assays using either primers for specific Mucorales genera, as well as pan-fungal assays targeting ribosomal targets followed by ITS sequencing, have successfully been used to identify Mucorales in different matrices, such as bronchoalveolar lavage fluid or tissue specimens3,4. Additionally, two different assays for detecting circulating Mucorales DNA in peripheral blood have been developed4,5. The assay by Millon et al. uses three different PCR reactions for the detection of Mucor/Rhizopus, Lichtheimia, and Rhizomucor, respectively5. On the other hand, the assay by Springer et al. uses a more generic approach and targets specific fragments of the 18S and 28S genes4.

Early diagnosis of mucormycosis is of utmost importance, since it may improve outcome. In clinical practice, laboratory diagnosis of mucormycosis includes histopathology, direct examination. As such, the current diagnosis of mucormycosis continues to rely on traditional microbiologic techniques such as fungal culture, direct microscopy (using optical brighteners), and histology, all of which have a notoriously low sensitivity3,5,6. Recently, molecular techniques have offered an additional opportunity to improve the diagnostic of mucormycosis 3,4. Methods on detection of Mucorales DNA in blood have shown promising results for earlier and rapid diagnosis and could be used as screening tests in high-risk patients3,5,6. This makes blood based PCR tests attractive as screening assays, as well as a diagnostic test in cases in which more invasive sampling is not feasible.

Purpose of the study:

·       To diagnose early which leads to prompt treatment, to reduce morbidity and mortality, to improve survival and to reduce surgical intervention.

·       Advantage of blood based test- detection 3-68 days earlier that conventional methods

·       To evaluate the sensitivity of qPCR/ Multiplex PCR assay for the detection of circulating Mucorales DNA in patients with invasive mucormycosis.

 
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