| CTRI Number |
CTRI/2024/04/066092 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of fungal infections of respiratory tract in adults |
|
Scientific Title of Study
|
Clinical and microbiological profile of fungal infections of respiratory tract in adults |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aman S Chandel |
| Designation |
1st year Junior Resident, Department of Microbiology |
| Affiliation |
Kasturba Medical College, MANIPAL |
| Address |
Department of Microbiology, Basic sciences building , 2nd floor , Kasturba Medical College, Madhavnagar , MANIPAL 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7018875722 |
| Fax |
|
| Email |
chandelaman4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KIRAN CHAWLA |
| Designation |
PROFESSOR ,DEPARTMENT OF MICROBIOLOGY |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Microbiology , Basic sciences building, 2nd floor , Kasturba Medical College , Madhavnagar , Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9980220484 |
| Fax |
|
| Email |
kiran.chawla@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR KIRAN CHAWLA |
| Designation |
PROFESSOR ,DEPARTMENT OF MICROBIOLOGY |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Microbiology, Basic sciences building , 2nd floor , Kasturba Medical College , Madhavnagar , MANIPAL 576104
KARNATAKA
576104
India |
| Phone |
9980220484 |
| Fax |
|
| Email |
kiran.chawla@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Madhavnagar, Manipal, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Institutional Grant Kasturba Medical College Manipal |
| Address |
Kasturba Medical College, Madhavnagar, Manipal, India - 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Aman S Chandel |
Kasturba Medical College and Hospital |
Departments of Microbiology and Respiratory Medicine
Udupi
KARNATAKA |
7018875722
chandelaman4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
all patients above 18 years of age who are clinically suspected with fungal respiratory tract infections. |
|
| ExclusionCriteria |
| Details |
all the patients below 18 years of age and all the pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Information on predisposing factors and clinical presentation of patients with fungal respiratory infection can be obtained. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Information of common fungi which are capable of causing both the upper and lower respiratory tract infections and patients’ prognosis can be obtained. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/05/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objectives of the study are: a) To determine predisposing
factors for fungal infection of the respiratory tract. b) To evaluate the various
clinical presentations for fungal infection of respiratory tract. c) To analyse the frequency of
common fungi causing infections of upper and lower respiratory tract. d) To analyse the
prognosis of patients with fungal respiratory tract infections. |