| CTRI Number |
CTRI/2025/09/094077 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A hospital study to understand the common causes of long-lasting fever in people living in North Mumbai suburbs |
|
Scientific Title of Study
|
A prospective hospital based observational study about region specific epidemiology for extended fever in north mumbai sub urban region. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Neha Nemani |
| Designation |
DNB resident Department of Internal medicine |
| Affiliation |
Bhaktivedanta hospital and research institute |
| Address |
OPD 1, ground floor, bhaktivedanta hospital and research institute, srishti complex, bhaktivedanta swami marg, mira road (east), thane.
Thane
MAHARASHTRA
401107
India |
| Phone |
9819408011 |
| Fax |
|
| Email |
neha.nemani.nn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Dhaval Dalal |
| Designation |
Head of the Department of Internal Medicine |
| Affiliation |
Bhaktivedanta hospital and research institute |
| Address |
OPD 1, ground floor, bhaktivedanta hospital and research institute, srishti complex, bhaktivedanta swami marg, mira road (east), thane.
Thane
MAHARASHTRA
401107
India |
| Phone |
9322220944 |
| Fax |
|
| Email |
drdalal.rns@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Neha Nemani |
| Designation |
DNB resident Department of Internal medicine |
| Affiliation |
Bhaktivedanta hospital and research institute |
| Address |
OPD 1, ground floor, bhaktivedanta hospital and research institute, srishti complex, bhaktivedanta swami marg, mira road (east), thane.
Thane
MAHARASHTRA
401107
India |
| Phone |
9819408011 |
| Fax |
|
| Email |
neha.nemani.nn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta hospital and research institute, srishti complex, bhaktivedanta swami marg, mira road (east), thane - 401107, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta hospital and research institute |
| Address |
srishti complex, bhaktivedanta swami marg, mira road (east), thane - 401107, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neha Nemani |
Bhaktivedanta hospital and research institute |
srishti complex, bhaktivedanta swami marg, mira road (east)
Thane
MAHARASHTRA |
9819408011
neha.nemani.nn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedant Hospital Ethics Committe for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged more than or equal to 18 years from north Mumbai sub-urban region
2.Fever for more than 7 days,
3.temperature of more than 38.3 degree celcius or 100 degree ferhenite
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Known case of HIV with CD4 count less than 200
3.Known case of HIV not on ART
4.Age less than 18 Years
5.On Biologic therapies
6.Neutropenia
7.On steroid dose of more than 2mg per kg for more than 2 weeks within 3 months
8.Known case of malignancy/active malignancy
9.History of Hematopoietic Stem Cell Transplantation
10.healthcare associated infection
11.transferred in from another centre
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Then primary outcome will be Statistical elaboration of the prevalence of various aetiologies of extended fever in region of study as percentages. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Novel study in the said region to evaluate epidemiology of extended fever.
• Statistically elaborate the prevalence of various aetiologies of extended fever in region of study
• Contribution to existing knowledge for improved patient management.
• Better resource allocation and improved cost effectiveness.
• Overall – better Community health planning
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Extended fever origin remains one of the most difficult diagnostic challenges for a physician. Extended fever may have over 200 different aetiologies. Diagnostic strategies cannot follow one size fits all approach with the heterogeneity of presentations of cases of extended fever. Hence, the purpose of this observational study is to evaluate the comprehensive epidemiology of extended fever in the region of North Mumbai Sub Urban and suggest a region tailored approach to extended fever to enhance clinical-decision making and resource allocation. During this study, the Patients will undergo a complete assessment based on symptoms, history, clinical examination and the necessary test like blood counts, blood culture and ultrasound and if necessary, CT scan will be done. PET scan will be done if required. Patient will receive standard treatment based on the diagnosis. The thesis could offer insights into the unmet needs, harness new resources or establish approach that is both scientifically and clinically impactful |