| CTRI Number |
CTRI/2019/08/020741 [Registered on: 16/08/2019] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of Pythium Keratitis |
|
Scientific Title of Study
|
To see the efficacy of topical Linezolid 0.2%as a monotherapy in patients with Pythium Keratitis in comparison with the combination therapy of Linezolid 0.2% and Azithromycin 1% administered topically. |
| 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-Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
04030612615 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBhupesh Bagga |
| Designation |
Consultant-Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
04030612615 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrBhupesh Bagga |
| Designation |
Consultant-Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
04030612615 |
| Fax |
04023548271 |
| Email |
bhupesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
| LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana. |
|
|
Primary Sponsor
|
| Name |
LV Prasad Eye Institute |
| 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 |
| Dr Bhupesh Bagga |
LV Prasad Eye Institute |
LV Prasad Eye Institute,
LV Prasad Marg,
Room No 123,Clinical Research Department,1st floor , GPR building
Banjara hills, road No :2
Hyderabad-500034
Telangana
Hyderabad
TELANGANA |
04030612615
04023548271
bhupesh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committe, LV 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 |
combination therapy of Linezolid 0.2% and Azithromycin 1% |
Patients of pythium keratitis |
| Intervention |
Linezolid 0.2% |
Use this drop in patients of pythium keratits.
Topically every hourly for 2 weeks followed by 2 hourly till the time of resolution
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.All cases with microbial keratitis confirmed on smears and/or culture as Pythium by Microbiologist.
2.Size of infiltrate less or equal to 8 mm excluding the tentacles.
3.Had not used previously Azithromycin or linezolid
4.Ready to give consent
5.Consent for regular follow-up
6.More than 18 years
|
|
| ExclusionCriteria |
| Details |
1.Mixed infection on smears or cultures
2.Known Allergy to Linezolid or Azithromycin
3.Size of infiltrate > 8 mm
4.Not willing to come for regular follow-up or admission or giving consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ulcer completely resolved on medical therapy or application of tissue adhesive for thinning. |
Ulcer completely resolved on medical therapy or application of tissue adhesive for thinning. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of patients undergone therapeutic Penetrating keratoplasty (TPK) for worsening of infection. |
1 month, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2019 |
| Date of Study Completion (India) |
24/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIl |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Retrospective analysis of cases with laboratory proven P. insidiosum keratitis cases will be done by review of medical and microbiology records and the data will be analyzed for epidemiological and clinical characteristics. 2. Evaluate the efficacy Linezolid 0.2% as a monotherapy in patients with corneal infection by P. insidiosum and compare with the combination therapy (topical Linezolid 0.2% and Azithromycin 1%) in a Prospective clinical trial 1. |