| CTRI Number |
CTRI/2020/12/029629 [Registered on: 07/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Potential role of topical Tigecycline for for Pythium Keratitis |
|
Scientific Title of Study
|
"Use of antibiotics in the Medical Management of Pythium Keratitis: Pilot Study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, Ophthalomology |
| Affiliation |
L V Prasad Eye Institute |
| Address |
LV Prasad Eye Institute, Room No:123, Clinical Research Department,GPR Building,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102615 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, Ophthalomology |
| Affiliation |
L V Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,Room No:123,Clinical Research Department,GPR Building,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
TELANGANA
500034
India |
| Phone |
04068102615 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrBhupesh Bagga |
| Designation |
consultant, Ophthalomology |
| Affiliation |
L V Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,Room No:123,Clinical Research Department,GPR Building,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
TELANGANA
500034
India |
| Phone |
04068102615 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Instituta |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana. |
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBhupesh Bagga |
L V Prasad Eye Institute |
Room No:123,Clinical Research Department,GPR Building,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA |
04068102615
04023548271
bhupesh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Use of Tigecycline eye drop |
Each infected eye will be be treated with Tigecycline 1% and Azithromycin ointment 1% and Tab azithromycin 500 mg twice a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Age equal to or more than 18 years.
2) Male or female
3) Stromal infiltrate size between 2-8 mm.
4) Corneal scraping positive for Aseptate broad ribbon like filaments characteristic of Pyhthium in direct smear examination by any one or more of the methods used.
|
|
| ExclusionCriteria |
| Details |
1) The corneal scrapings are negative for Pythium
2) The patient has a history of allergy to any of drugs used.
3) The cornea or sclera has been perforated or perforation is impending.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of keratities |
1 week, 2 week, 3 week, 1 month, 3 month, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual acuity, number of PK required |
1 week, 2 week, 3 week, 1 month, 3 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
07/12/2020 |
| 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="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Corneal
infection caused by Pythium Insidiosum is a highly morbid and sight threatening
disease.1 It can be identified by the zoospore formation method on
culture.2 Being an oomycete it has a cell wall made of cellulose and
chitin and hence there is poor response to anti-fungal drugs targeting the ergosterol
biosynthesis pathway.3 It is known to respond poorly to commonly
used therapy such as anti-fungals, antibiotics and also has a high recurrence
following therapeutic penetrating keratoplasty(TPK).1,4 We reported relative success with combination
of antibacterial antibiotics as a primary treatment which was formulated based
on in-vitro susceptibility.5 Subsequently we also reported that
fewer patients underwent TPK with this regime, the outcomes were better in
terms of elimination of infection and there was a reduced recurrence rate.
6 In-vitro susceptibility tests provide clinically relevant information
that would aid in appropriate selection of drugs.7 We have tried combination of Linezolid
and azithromycin for the treatment of Pythium keratitis. Based on the Pythium
inviro and animal trial Tigecycline seems to be nice alternative for Pythium
keratitis. We are planning pilot trial to see its efficacy in combination with
Linezolid and see its efficacy as combination therapy.
|