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CTRI Number  CTRI/2018/05/013668 [Registered on: 03/05/2018] Trial Registered Prospectively
Last Modified On: 31/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A phase 3 Study to assess the Effectiveness Safety Tolerability and Pharmacokinetics (what happens to drug in body) of SCY 078 (antifungal drug) in Patients with Candidiasis (Fungal infection) including Candidemia (Fungus in blood ) Caused by Candida auris (Type of fungus) 
Scientific Title of Study   Open-Label Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SCY 078 in Patients with Candidiasis, Including Candidemia, Caused by Candida auris. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SCY-078-305 Date:06 Oct 2017 Version:1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Puneet Dhar 
Designation  Professor & head of the department of GI surgery  
Affiliation  Amrita Institute of Medical Sciences and Research Centre 
Address  Amrita Institute of Medical Sciences and Research Centre department of GI surgery First Floor GI surgery Unit PO AIMS Ponekkara Cochin

Ernakulam
KERALA
682 041
India 
Phone  9447736769   
Fax  914846681124  
Email  pdhar@aims.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Anand Eswaraiah MD 
Designation  Head Regulatory Affairs Department Clinical Development  
Affiliation  Syngene International Limited, Clinical Development 
Address  Syngene International Limited Clinical Development division Tower 1 Semicon Park Electronics City Phase 2 Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  9945622776  
Fax  08023601983  
Email  anand.eswaraiah@syngeneintl.com  
 
Details of Contact Person
Public Query  
Name  Dr Anand Eswaraiah MD 
Designation  Head Regulatory Affairs Department Clinical Development  
Affiliation  Syngene International Limited, Clinical Development 
Address  Syngene International Limited Clinical Development division Tower 1 Semicon Park Electronics City Phase 2 Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  9945622776  
Fax  08023601983  
Email  anand.eswaraiah@syngeneintl.com  
 
Source of Monetary or Material Support  
SCYNEXIS Inc. 101 Hudson Street,Suite 3610 Jersey City NJ 07302  
 
Primary Sponsor  
Name  SCYNEXIS Inc  
Address  101 Hudson Street, Suite 3610 Jersey City NJ 07302  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     United States of America
India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Puneet Dhar  Amrita Institute of Medical Sciences  Amrita Institute of Medical Sciences and Research Centre department of GI surgery First Floor GI surgery Unit PO AIMS Ponekkara Cochin
Ernakulam
KERALA 		 9447736769
91-484-6681124
pdhar@aims.amrita.edu 
Dr Sulekha Saxena  King George Medical University, Lucknow  King George Medical University Department of Critical Care Medicine, King George Medical University, Chowk, Lucknow – 226003, Uttar Pradesh, India.
Lucknow
UTTAR PRADESH 		 7376636039

dr.sulekha2008@gmail.com 
Dr Deven Juneja   Max Super Specialty Hospital New Delhi  Institute of Critical Care Medicine Max Super Specialty Hospital, 2, Press Enclave Road, Saket New Delhi 110017
West
DELHI 		 9818290380

deven.juneja@maxhealthcare.com 
DrNarayana Yaddanapudi  Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh  Department of Anaesthesia and special care,Postgraduate Institute of Medical Education and Research, Chandigarh, India 160012
Chandigarh
CHANDIGARH 		 9815836656

narayana.yaddanapudi@gmail.com 
Dr Ross Cecil Reuben   St. Johns Medical College Hospital  St. Johns Medical College Hospital Dept. of Medicine and Hematology Sarjapur Road 560034 Bangalore Karnataka India.
Bangalore
KARNATAKA 		 9448493705
08022065229
cecilrross@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee Amrita Institute of Medical Sciences Cochin  Approved 
Institutional Ethics Committee King George Medical University, Lucknow  Approved 
Institutional Ethics Committee Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh  Approved 
Institutional Ethics Committee St John s Medical College  Approved 
Max Healthcare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with Candidiasis, Including Candidemia, Caused by Candida auris ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  SCY-078 750 mg Tablets (3 tablets of 250 mg)  oral loading dose of 750 mg of SCY-078 (3 tablets of 250 mg) BID during the first 2 days of treatment and then subsequent oral doses of 750 mg QD for up to 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subject is a male or female adult ≥18 years of age on the day the study informed consent form (ICF) is signed.
2.Subject has a documented candidiasis, including candidemia,caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances.
A documented candidiasis, including candidemia, caused by Candida auris is defined as the
recovery of Candida auris by culture of a sample obtained within the last 7 days.
3.Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.
4.Subject is not pregnant and is highly unlikely to become pregnant or to impregnate a partner since he/she meets at least one of the following criteria:
a.Subject is a female subject who is not of reproductive potential and is eligible without
requiring the use of contraception. A female subject who is not of reproductive potential
is defined as one who: (1) has reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (3) has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (i.e., anorexia nervosa).
b.Subject is a male subject who is not of reproductive potential and is eligible without
requiring the use of contraception. A male subject who is not of reproductive potential is
defined as one whom has undergone a successful vasectomy. A successful vasectomy is defined as (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.
c.Subject is a male or female subject who is of reproductive potential and agrees to remain
abstinent or use (or have his/her partner use) 2 acceptable methods of contraception starting from the time of consent through 28 days after the completion of study therapy.
Acceptable methods of birth control are intrauterine device, condom, hormonal contraceptives and vasectomy.
It is not yet known if the use of SCY-078 reduces the efficacy of hormonal contraception (including but not limited to oral, injectable, or implantable methods). Therefore,
hormonal contraception should not be used without a second study acceptable method of
birth control.
Note:Women of childbearing potential must have a negative serum pregnancy test (β-human
chorionic gonadotropin [β-hCG]) prior to enrollment (performed by the site’s local
laboratory).
5.Subject and/or legal representative is/are able to understand and sign a written ICF, which must be obtained prior to treatment and any study-related procedures.
6.Subject and/or legal representative is able to understand and sign a consent or authorization form, which shall permit the use, disclosure and transfer of the subject’s personal health information (e.g., in the US, a Health Information Portability and Accountability Act Authorization form).
7.Subject and/or legal representative is able to understand and follow all study-related
procedures including study drug administration. 
 
ExclusionCriteria 
Details  1.Subject has a fungal disease with central nervous system involvement.
2.Subject has a fungal disease of the bone and/or joint that is expected to require >90 days of study drug treatment.
3.Subject has an inappropriately controlled fungal infection source (e.g. persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
4.Subject is hemodynamically unstable and/or requiring vasopressor medication for blood
pressure support.
5.Subject has abnormal liver test parameters: AST or ALT >10 x ULN and/or total bilirubin >5
x ULN. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of SCY-078 as determined by a Data Monitoring Committee (DMC) by assessing global success (composite assessment of clinical and mycological success) at End
of Treatment (EoT). 		 Efficacy as measured by the percentage of subjects with global success (complete or partial global response) at EoT as determined by the DMC. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety and tolerability of SCY-078
To evaluate the efficacy of SCY-078 by measuring recurrence of the baseline fungal infection 42 days after EoT (Week 6 Follow up)
To determine the efficacy of SCY-078 by measuring subject survival 42 and 84 days after Day 1 (first dose of study drug) 		 Safety and tolerability as measured by: Physical examination, vital signs, 12-lead electrocardiogram (ECG), safety laboratory
tests, AEs and treatment discontinuations The percentage of subjects with treatment-emergent AEs 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3 
Date of First Enrollment (India)   28/05/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/05/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="12" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   We will update 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Candida auris is an emerging fungus that presents a serious global health threat. Healthcare facilities in several countries have reported that C. auris has caused severe illness in hospitalized patients. Some strains of Candida auris are resistant to all three major classes of antifungal drugs.This type of multidrug resistance has not been seen before in other species of Candida. Also of concern, C. auris can persist on surfaces in healthcare environments and spread between patients in healthcare facilities, unlike most other Candida species. The CDC surveillance data conducted in developed countries have reported that approximately 7% of all Candida bloodstream isolates tested are resistant to fluconazole and some Candida strains are increasingly resistant to first-line and second-line antifungal treatment agents, including azoles and echinocandins. Centers specialized in the treatment of immune-compromised patients report increased frequency of non-albicans species of Candida with higher incidence of resistance.

India being burdened with multiple immunocompromised disease conditions, secondary infection with candida has higher prevalence rate and the incidence rate is increasing day by day.  Many of the candida infectious conditions treated with existing antifungal drugs have developed resistance to these drugs. Lack of alternative treatment regimens have added up to high morbid and mortality rates in these conditions.

SCY-078 has been evaluated against >1600 Candida isolates, including all clinically relevant species, more than 400 C. glabrata isolates and >100 C. auris isolates.

The study will be conducted at approximately 10 sites globally, and is planned to enroll and treat approximately 30 subjects. Thus India will be one of the country to contribute for the global assessment.

 
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