| CTRI Number |
CTRI/2017/04/008362 [Registered on: 17/04/2017] Trial Registered Prospectively |
| Last Modified On: |
14/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy and Safety of the Drug Product Caspofungin |
|
Scientific Title of Study
|
International, multicentre, randomized, open-label, comparative clinical study of efficacy and safety of the drug product Caspofungin lyophilized for solution for infusion 50 mg and 70 mg manufactured by Camus Pharma Pvt. Ltd., India and the drug product Cancidas® lyophilized for solution for infusion 50 mg and 70 mg manufactured by Merck Sharp & Dohme BV., Netherlands in patients with invasive candidiasis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CASPO-III-08/2015, Version 1.1, April 11, 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Bhatt |
| Designation |
Director |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
09167243914 |
| Email |
hbo@nexuscro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh khadakban |
| Designation |
Clinical Operations |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
09167243914 |
| Email |
mangesh.khadakban@nexuscro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh khadakban |
| Designation |
Clinical Operations |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
09167243914 |
| Email |
mangesh.khadakban@nexuscro.com |
|
|
Source of Monetary or Material Support
|
| JSC Pharmasyntez, Russia Registered address: 664007, Irkutsk, Krasnogvardeyskaya st., 23, office 3 |
|
|
Primary Sponsor
|
| Name |
JSC Pharmasyntez Russia |
| Address |
Russia Registered address: 664007, Irkutsk, Krasnogvardeyskaya st., 23, office 3 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nexus Clinical Research India Ltd |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India |
|
|
Countries of Recruitment
|
India
Russian Federation |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B Dwari |
Hi Tech Medical College & Hospital |
Hi Tech Medical College & Hospital
Department of Medicine Second floor Room No. 02 Division Skin Department, Pandara Rasulgarh Bhubaneshwar Odisha 751025 Cuttack ORISSA Cuttack ORISSA Cuttack ORISSA
Khordha
ORISSA |
9439129178
dr.dwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hi Tech Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
In patients with invasive candidiasis., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Name of the reference drug: Cancidas®
|
Name of the Marketing Authorization Holder: Merck Sharp & Dohme BV., the Netherlands
Dosage Form: lyophilized for solution for infusion
Description: white to off-white solid lyophilized cake
Day 1, loading dose: 70 mg administered as intravenous infusion for 1 hour (as a single dose).
Maintenance dose: 50 mg administered as intravenous infusion for 1 hour once a day intravenously.
Duration: 28±2 Days
|
| Intervention |
Name of the test drug: Caspofungin
|
Manufacturer: Camus Pharma Pvt. Ltd., India
Dosage Form: lyophilized for solution for infusion
Description: White to off-white lyophilized solution
Day 1, loading dose: 70 mg administered as intravenous infusion for 1 hour (as a single dose).
Maintenance dose: 50 mg administered as intravenous infusion for 1 hour once a day intravenously.
Duration: 28±2 Days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients that are capable and willing to comply with protocol and voluntarily signed the Informed Consent Form prior any study procedure;
2 Patients with invasive candidiasis including candidemia and acute disseminated candidiasis, and confirmed positive result of the following examinations detection of fungi of Candida species through histological examination, cytological examination or direct microscopy of a sample obtained through exploratory puncture or biopsy sampling from normally sterile bio-substrate within the period of the last 4 days.
3 positive result of triple inoculations (within 24 hours) of peripheral blood samples to detect Candida spp., obtained in patients with body temperature exceeding 38°С or having other signs of generalized inflammation response.
4 In case of acute disseminated candidiasis –candidemia in combination with Candida spp. detected through histological examination and/or inoculation of samples obtained from deep tissues of two or more locations. |
|
| ExclusionCriteria |
| Details |
1 Pregnant or breast feeding patients.
2 Patients with hepatic diseases with Child-Pugh score exceeding 9.
3 Patients with life expectancy less than half a year.
4 Patients diagnosed with or suspected of Candida endocarditis, osteomyelitis or meningitis.
5 Combined fungemia.
6 Patients with neutropenia (neutrophil count ≤1000/μl).
7 Patients underwent organ transplantation.
8 Hindered vein access complicating intravenous administration of the drug.
9 Concomitant treatment with cyclosporine.
10 Echinocandin treatment within period of 1-month prior randomizatio |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Clinical response rate in patients with invasive candidiasis, including candidaemia and acute disseminated candidiasis, in each treatment group.
2 Bacterial efficacy rate
|
at the end of the therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of stay of the compared groups’ patients in the hospital. |
At the end of the therapy |
| Relapse rate |
At the follow-up visit. |
|
|
Target Sample Size
|
Total Sample Size="244"
Sample Size from India="194"
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)
|
20/04/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/04/2017 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a prospective, randomized, multicentre, open-label, comparative study. After having signed the Informed consent the successfully screened patients with clinical signs and symptoms of invasive candidiasis and without neutropenia, meeting all the inclusion and none of exclusion criteria, will be included in the study. Patients are proposed to be in the hospital for at least 28 days. A patient diagnosed with clinical and microbiological recovery will be discharged from the hospital and switched to out-patient treatment. The study will be initiated from evaluation of inclusion/exclusion criteria in the course of screening visit. Patients meeting all the inclusion criteria at moment of the randomisation visit will be randomised in one of the study groups at a ratio of 1:1 to receive either the test drug Caspofungin (70 mg at day 1 followed by 50 mg) once a day intravenously or the reference drug Cancidas® (70 mg at day 1 followed by 50 mg) once a day intravenously. Caspofungin maintenance dose will be adjusted to 35 mg for the patients with moderate hepatic impairment, diagnosed according to Child-Pugh score in the range of 7 to 9. Dosage adjustment will not be required for the patients with renal impairment. TD/RD extent of exposure will be individual for each of patients and will be at least 14 days after the negative culture-based test in blood or infection site are obtained and clinical signs of invasive candidiasis are stopped. 28 ± 2 days after TD/RD treatment termination, relapse rate and safety parameters will be assessed. |