CTRI Number |
CTRI/2023/05/052614 [Registered on: 15/05/2023] Trial Registered Prospectively |
Last Modified On: |
12/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Prospective study |
Study Design |
Other |
Public Title of Study
|
Clinical outcomes of Mucormycosis |
Scientific Title of Study
|
A mixed method study to explore the clinical outcomes among patients with ororhino orofacial and maxillary mucormycosis admitted at tertiary care centre,Jaipur (Rajasthan) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
VIRENDRA SINGH |
Designation |
NURSING TUTOR |
Affiliation |
GOVERNMENT COLLEGE OF NURSING,SIKAR(RAJ) |
Address |
DEPT OF PSYCHIATRIC NURSING,GOVERNMENT COLLEGE OF NURSING. GNMTC BUILDING, PIPRALI SIKAR,(RAJASTHAN) S.K.GOVERNMENT MEDICAL COLLEGE,SIKAR RAJASTHAN Sikar RAJASTHAN 302027 India |
Phone |
09460103856 |
Fax |
|
Email |
SINGHVIRENDRA809@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shashidhara YN |
Designation |
Professor and HOD, Dept of Community Health Nursing |
Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL KARNATAKA |
Address |
Department of Community Health Nursing
Manipal College of Nursing, MAHE Manipal
Department of Community Health Nursing
Manipal College of Nursing, MAHE Manipal KARNATAKA
Udupi KARNATAKA 576104 India |
Phone |
09886344627 |
Fax |
|
Email |
shashidhara.yn@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
VIRENDRA SINGH |
Designation |
NURSING TUTOR |
Affiliation |
GOVERNMENT COLLEGE OF NURSING,SIKAR(RAJ) |
Address |
DEPT OF PSYCHIATRIC NURSING,GOVERNMENT COLLEGE OF NURSING. GNMTC BUILDING, PIPRALI SIKAR,(RAJASTHAN) S.K.GOVERNMENT MEDICAL COLLEGE,SIKAR RAJASTHAN Sikar RAJASTHAN 302027 India |
Phone |
09460103856 |
Fax |
|
Email |
SINGHVIRENDRA809@GMAIL.COM |
|
Source of Monetary or Material Support
|
RUHS COLLEGE OF DENTAL SCIENCES AND HOSPITAL,JAIPUR (RAJASTHAN) |
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Other [Self Sponsored] |
|
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 |
VIRENDRA SINGH |
RUHS COLLEGE OF DENTAL SCIENCES AND HOSPITAL, JAIPUR (RAJASTHAN)R d |
Department of oral Maxillo facial surgery. Department no. -2 AND WARD OF ORAL MAXILO FACIAL SURGERY . FIRST FLOOR RUHS COLLEGE OF DENTAL HOSPITAL Jaipur RAJASTHAN |
9460103856
Singhvirendra809@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
OFFICE OF THE ETHICS COMMITTEE, RUHS COLLEGE OF DENTAL SCIENCES,SUBHASH NAGAR,JAIPUR302016 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B088||Other specified viral infections characterized by skin and mucous membrane lesions, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
For Qualitative Study sample will selected for study who full fill following criteria
Biopsy Proved Mucormycosis patient.
Patient who are admitted at RUHS College of Dental Science Jaipur
Patient with or without history of COVID 19 .
Patient who will admitted at the time of data collection. Or discharged from hospital within 3 days or near about to discharge.
Patient who respond to question during collection of qualitative data.
If Patient unable to respond due to surgical procedure then get information from care giver.
|
|
ExclusionCriteria |
Details |
For Qualitative study patient will excluded from study-
Patient who discharged from hospital and more than 3 days.
Patient have another Oral cavity complication from long time before getting mucormycosis infection.Patient who not willing to participate study.
Patient with Mucormycosis involed other than Orofacial area.
Children are excluded |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To explore the experiences regarding clinical outcome in terms of physical, social and psychological disturbances among the patients with mucormycosis. |
6 MONTHS |
|
Secondary Outcome
|
Outcome |
TimePoints |
find out the association between mucormycosis and selected variables (age, gender, COVID -19 ) among the patients with mucormycosis. |
6 Months |
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
17/05/2023 |
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="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
BACKGROUND- Mucormycosis (formerly known as zygomycosis) is an uncommon, opportunistic fungal infection primarily caused by Mucorales, a filamentous fungus of the Mucormycetes class. Mucormycosis is a rare but devastating fungal infection primarily affecting immunocompromised patients such as those with hematological malignancy, bone marrow and solid organ transplantation, and patients with diabetes, and, even more rarely, immune competent patients. (Dimitrios P. Kontoyiannis2016 ) Mucormycosis is an angiovasive infection caused by the ubiquitous filamentous fungi of the order Mucorales and class of Mucormycetes. Mucormycosis is emerging infection in COVID 19 Pandemic Era.(George Petrikkos, Anna Skiad 2021)
Thus all review and studies supported tha mucormycosis is a very dangerous infection among the patient with history of COVID19,DM, Immunocompromised condition .All these studies show many clinical outcomes in forms of disturbances among the patients inspite of taking treatment. Mucormycosis is emerging health issue as in COVID 19 Pandemic era so it is important to conduct the research study on this problem . In India there are very less no of research studies conducted on such emerging problem. PURPOSE OF STUDY – The Study aims to investigate the clinical feature of mucormycosis, History of COVID 19 and specific system disorder and treatment outcome of admitted patients . This will help in find out the association of contributing factors and clinical outcome of patient as well as development of intervention according the need of patient . The study also aims to assess the prospective clinical outcome in form of physical , psychological and social status among patients admitted for treatment of mucormycosis .These outcomes will helpful in development of intervention of physical, psychological and social dimension of care of patient with mucormycosis. |