| CTRI Number |
CTRI/2018/04/013319 [Registered on: 17/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
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Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
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Public Title of Study
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An Observational Study to Evaluate the Safety and Tolerability of Minocycline Hydrochloride Injection in Indian Patients with Multi Drug Resistant Gram-Negative Bacterial Infections. |
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Scientific Title of Study
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An Observational, Practice based, Open label, Prospective Non Comparative, Multicenter, Post Marketing Surveillance Study to Assess Safety and Tolerability of Minocycline Hydrochloride 100 mg Intravenous (I.V.) Injection in Indian Patients with Multi-Drug Resistant Gram (MDR) Negative Bacterial Infections. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CP/09/16(Version 1.0 dated 04 Oct 2017) |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Sawant |
| Designation |
Head, Clinical Trials |
| Affiliation |
Cipla Ltd. |
| Address |
Cipla Ltd., Head Office, 289, Bellasis Road, Opposite Sahil Hotel, Mumbai Central East, Mumbai, Maharashtra. 400008.
Cipla Ltd., Head Office, 289, Bellasis Road, Opposite Sahil Hotel, Mumbai Central East, Mumbai, Maharashtra. 400008.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
022-24814909 |
| Fax |
|
| Email |
Sandesh.sawant3@cipla.com |
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Details of Contact Person
Public Query
|
| Name |
Mr Satish Marukurthi |
| Designation |
Chief Executive Officer |
| Affiliation |
Croissance Clinical Research |
| Address |
402, Vasu Heights, Plot No. 91,92,93, Lumbini Avenue, Lane Opp. Care Hospital, Gachibowli,
Hyderabad
ANDHRA PRADESH
500032
India
Hyderabad
ANDHRA PRADESH
500032
India |
| Phone |
9515161468 |
| Fax |
|
| Email |
ceo@croissancecr.com |
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Source of Monetary or Material Support
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| Cipla Ltd., Head Office, 289, Bellasis Road, Opposite Sahil Hotel, Mumbai Central East, Mumbai, Maharashtra. 400008. |
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Primary Sponsor
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| Name |
Cipla Ltd |
| Address |
Cipla Ltd., Head Office, 289, Bellasis Road, Opposite Sahil Hotel, Mumbai Central East, Mumbai, Maharashtra. 400008. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajib Paul |
Apollo Hospitals |
Department of Internal Medicine & Critical Care,Jubilee Hills,Hyderabad-500033,Telangana.
Hyderabad
ANDHRA PRADESH |
9849079541
drrajibpaul@gmail.com |
| Dr Hemant HR |
Mazumdar Shaw Medical Center A Unit of Narayana Hrudayalaya |
Department of Internal Medicine, No.258/A, Hosur Road, Anekal Taluk, Bommasandra Industrial Area, Bangalore, Karnataka - 56009
Bangalore
KARNATAKA |
9916141408
hemanthr25@gmail.com |
| Dr D Prasada Rao |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
Department of Surgery, Research Wing, 2nd Floor, Beside FM Ward, Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
Srikakulam
ANDHRA PRADESH |
9849702720
drprasadaraod@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RIMS, Srikakulam |
Approved |
| Instuitional Ethics Comittee-Clinical studies Apollo Hospitals |
Submittted/Under Review |
| Narayana Health Medical Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, The patients with Multi Drug Resistant Gram Negative Bacterial Infections., |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Minocycline hydrochloride (Divaine 100 mg) |
Subjects will be administered with 200 mg/day in 2 divided doses (Intravenous infusion)
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Written signed and dated informed consent (patient or LAR)
2. Either gender with age 18 years and above
3. Patients with Multi-Drug Resistant (MDR) gram negative bacterial infection
4. Documented bacteriological infection susceptible to Minocycline Hydrochloride. |
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| ExclusionCriteria |
| Details |
1. Known hypersensitivity to Minocycline Hydrochloride or any of its components
2. Patient unsuitable to participate in the study as per the discretion of investigator
3. Pregnant or nursing females
4. Any other condition in the opinion of the investigator would affect the safety of the patient if Minocycline Hydrochloride is administered. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related)
2.Percentage of patients with adverse events
3.Treatment discontinuation rates |
During Treatment period
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Secondary Outcome
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| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Post Marketing Surveillance |
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Date of First Enrollment (India)
|
30/04/2018 |
| 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 |
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Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
None |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This is an observational, practice-based, open-label, multicenter, post-marketing surveillance study. This study is to assess the safety and tolerability of minocycline hydrochloride 100 mg intravenous (I.V.) injection in Indian patients with multi-drug resistant gram (MDR) negative bacterial infections. Patients who are hospitalized with a confirmed MDR gram-negative bacterial infections will be enrolled in this study The study duration will be at the discretion of the investigator. Croissance Clinical Research is providing the Clinical Trial management Support to this clinical study. |