| CTRI Number |
CTRI/2021/10/037466 [Registered on: 22/10/2021] Trial Registered Prospectively |
| Last Modified On: |
08/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess predisposing factors in patients of mucormycosis following COVID infection at a tertiary hospital in North India |
|
Scientific Title of Study
|
Epidemiological analysis in patients of Mucormycosis at a tertiary care center in North India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NITIKA BERI |
| Designation |
Senior Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Room number 510, Department of Ophthalmology, University college of Medical Sciences and GTB Hospital
East
DELHI
110095
India |
| Phone |
9871130760 |
| Fax |
|
| Email |
berinitika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NITIKA BERI |
| Designation |
Senior Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Room Number 510, Department of Ophthalmology, University College of Medical Sciences and GTB Hospital
East
DELHI
110095
India |
| Phone |
9871130760 |
| Fax |
|
| Email |
berinitika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NITIKA BERI |
| Designation |
Senior Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Room Number 510, Department of Ophthalmology, University College of Medical Sciences and GTB Hospital
East
DELHI
110095
India |
| Phone |
9871130760 |
| Fax |
|
| Email |
berinitika@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi -110095 |
|
|
Primary Sponsor
|
| Name |
NITIKA BERI |
| Address |
Department of Ophthalmology,UCMS and GTB Hospital, Dilshad Garden, Delhi -110095 |
| Type of Sponsor |
Other [Self] |
|
|
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 NITIKA BERI |
University College of Medical Sciences And GTB Hospital |
Room Number 510, ward 15, Department of Ophthalmology
East
DELHI |
9871130760
berinitika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GURU TEG BAHADUR ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: B463||Cutaneous mucormycosis, (3) ICD-10 Condition: B464||Disseminated mucormycosis, (4) ICD-10 Condition: B465||Mucormycosis, unspecified, (5) ICD-10 Condition: B461||Rhinocerebral mucormycosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Mucormycosis admitted at the tertiary care center |
|
| ExclusionCriteria |
| Details |
Patients without Mucormycosis admitted at the hospital and patients who do not give consent to be a part of the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess predisposing factors for Mucormycosis |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of severity of disease with predisposing factors. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2021 |
| Date of Study Completion (India) |
30/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Indian Journal of Public Health |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A surge of cases of Mucormycosis post second wave of Covid -19 has been seen in India. Through this questionnaire based study we aim to assess the predisposing factors of Mucormycosis to prevent another epidemic to black fungus in India. |