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CTRI Number  CTRI/2021/09/037013 [Registered on: 30/09/2021] Trial Registered Prospectively
Last Modified On: 20/10/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   An Investigator initiated study comparing of two antifungals Anidulafungin and Caspofungin in patients with Invasive Candida Infections 
Scientific Title of Study   A prospective, observational, open label study to evaluate efficacy and safety of Anidulafungin in comparison to Caspofungin in Invasive Candida infections in India (ADVANCE) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yatin Mehta 
Designation  Chairman 
Affiliation  Medanta The Medicity 
Address  First Floor, Medanta Institute of Critical Care and Anesthesiology Medanta The Medicity CH Baktawar Singh Road, Sector 38 Gurugram

Gurgaon
HARYANA
122001
India 
Phone  01244141414   
Fax    
Email  yatin.mehta@medanta.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Yatin Mehta 
Designation  Chairman 
Affiliation  Medanta The Medicity 
Address  First Floor, Medanta Institute of Critical Care and Anesthesiology Medanta The Medicity CH Baktawar Singh Road, Sector 38 Gurugram

Gurgaon
HARYANA
122001
India 
Phone  01244141414   
Fax    
Email  yatin.mehta@medanta.org  
 
Details of Contact Person
Public Query  
Name  Dr Yatin Mehta 
Designation  Chairman 
Affiliation  Medanta The Medicity 
Address  First Floor, Medanta Institute of Critical Care and Anesthesiology Medanta The Medicity CH Baktawar Singh Road, Sector 38 Gurugram

Gurgaon
HARYANA
122001
India 
Phone  01244141414   
Fax    
Email  yatin.mehta@medanta.org  
 
Source of Monetary or Material Support  
Viatris, 11th Floor, Prestige Platina, Block 3, Kadubeesanahalli Village, Varthur Hobli, Outer Ring Road, Bangalore 560 087 
 
Primary Sponsor  
Name  Dr Yatin Mehta 
Address  First Floor, Medanta Institute of Critical Care and Anesthesiology Medanta The Medicity CH Baktawar Singh Road, Sector 38 Gurugram Haryana 122001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishnu Rao  Apollo Health City  Department of Internal Medicine, Ground Floor, Apollo Hospitals, Jubilee hills, Hyderabad-500033
Hyderabad
TELANGANA 		 9966769630

vishpolati@gmail.com 
Dr Charles Panackel  Aster Medicity  Clinical Research Department Second Floor Annex Building Aster Medcity hospital Kuttisahib Road South Chittoor PO Cheranelloor Kochi 682027 Kerala India
Ernakulam
KERALA 		 9744790970

drcharles.panackel@asterhospital.com 
Dr Rajesh Mahajan  Dayanand Medical College Hospital  Research and development center, Basement, Serai Building, Dayanand medical College and hospital, Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001
Ludhiana
PUNJAB 		 9815620102

dr_rajesh_mahajan@dmch.com 
Dr Prachee Sathe  Grant Medical Foundation Ruby Hall Clinic  First Floor, ICU, Main Building Grant Medical Foundation Ruby Hall Clinic, 40, Sassoon Road, Pune – 411001, Maharashtra, India
Pune
MAHARASHTRA 		 9960686867

prachee.sathe@gmail.com 
Dr Yatin Mehta  Medanta Institute of Critical Care and Anesthesiology  First Floor, Medanta Institute of Critical Care and Anesthesiology Medanta The Medicity CH Baktawar Singh Road, Sector 38 Gurugram - 122001
Gurgaon
HARYANA 		 9971698149

yatin.mehta@medanta.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Drug Trial Ethical Committee, Dayanand Medical College & Hospital, Ludhiana   Approved 
Institutional Ethics Committee-Biomedical Research, Apollo Hospitals  Approved 
Institutional Research and Ethics committee, Aster Medcity, Kochi  Approved 
Medanta Institutional Ethics Committee, Medanta-The Medicity  Approved 
Poona medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B377||Candidal sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients of either sex with age ≥18 years with a confirmed cases of Invasive Candida infection.
2. Patients who will be able to provide the informed consent.
3. Patients prescribed with Caspofungin or Anidulafungin

 
 
ExclusionCriteria 
Details  1. Patients of either sex with age less than 18 years.
2. Patients with aspergillus or any other mold or yeast [Cryptococcus] infections.
3. Patients on Micafungin or other antifungal agents.
4. Pregnant or breast-feeding women  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy and safety of Anidulafungin and Caspofungin in Invasive Candida infections in ICUs.   Day 1 to Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the distribution pattern of co-morbidities and risk factors for Invasive Candida infection  Day 1 to Day 14 
To determine the duration of treatment, number of hospital days and mortality of patients with Invasive Candida Infection.   Day 1 to Day 14 
To assess the clinical signs and symptoms, baseline candida pathogen, candida scores  Day 1 to Day 14 
To assess liver and renal functioning.   Day 1 to Day 14 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   15/10/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective, observational, multicenter, open label study to evaluate and compare the safety and efficacy of 180 adult patients with Invasive Candida infection at 5-7 sites across India. Prior to being enrolled into the study patients must provide a written authorization to the investigator to use or disclose personal and/or clinical data and meet the study eligibility criteria.


The data points to be considered in the study shall include demography, anthropometry, vital signs, body temperature, medical history, prior medications, risk factors for candida, candida scores, microbiology testing, laboratory assessments, concomitant medication, clinical evaluation including APACHE II scores and microbiological evaluation, any treatment emergent adverse events, treatment given and any change in dose or treatment during the hospitalization period 
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