| CTRI Number |
CTRI/2021/09/036930 [Registered on: 28/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to observation patients with cancer who develop fever on chemotherapy due to low white cell count |
|
Scientific Title of Study
|
Febrile Neutropenia in the Oncological setting: A prospective observational study |
| Trial Acronym |
FN-ONE STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lingaraj Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Adult Hematology. OPD no. 81, Main Building Ground Floor, Dr. Ernest Borges Road. Parel. Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
lingarajnayak86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lingaraj Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Adult Hematology. OPD no. 81, Main Building Ground Floor, Dr. Ernest Borges Road. Parel. Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
lingarajnayak86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lingaraj Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Adult Hematology. OPD no. 81, Main Building Ground Floor, Dr. Ernest Borges Road. Parel. Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
lingarajnayak86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. Ernest Borges Road. Parel. Mumbai. Pin Code-400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. Ernest Borges Road. Parel. Mumbai. Maharashtra. Pin Code-400012 |
| 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 Lingaraj Nayak |
Tata Memorial Hospital |
Department of Adult Medical Oncology, OPD no. 81, Ground Floor, Main Building. Dr. Ernest Borges Road. Parel. Mumbai. Pin Code-400012
Mumbai (Suburban)
MAHARASHTRA |
02224177210
lingarajnayak86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-I, IRB, Tata Memorial Hospital, Third Floor, Main Building, Dr. Ernest Borges Road. Parel. Mumbai. Pin-400012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D701||Agranulocytosis secondary to cancer chemotherapy, (2) ICD-10 Condition: D709||Neutropenia, unspecified, (3) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a. Subjects with all age group will be included for the study.
b. Receiving chemotherapy for newly diagnosed or relapsed malignancy.
c. Febrile neutropenia defined as fever (temperature >100.4 F on two occasions within a 12 hour period or 101°F once) during neutropenia (absolute neutrophil count < 500 x 109 cells/L or absolute neutrophil count <1000 x 109 cells/L and falling)
|
|
| ExclusionCriteria |
| Details |
a. Non-chemotherapy related febrile neutropenia.
b. Fever due to underlying malignancy
c. Non neutropenic fever
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the outcomes of febrile neutropenia viz resolution of fever, progression to hemodynamic instability, ICU transfer and death. |
From the time of enrollment till resolution of the febrile neutropenia episode or death of the patient, whichever earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the incidence of MDR organism (Details in Appendix-2)
2. To evaluate baseline prognostic factors for outcome.
3. To evaluate patterns of care (escalation or de-escalation) and outcome.
4. To evaluate success to antibiotics and delay in chemotherapy.
|
Daily monitoring of from the enrollment, till recovery from infection, fever and/or neutropenia whichever happens earlier |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
01/10/2021 |
| 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="0"
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
|
Febrile neutropenia is the most common and serious adverse event on intensive chemotherapy. With the advent of multi-drug resistant bacterial sepsis the mortality due to infections is on the rise. We would like to prospectively study the spectrum of febrile neutropenia at our hospital across all disease management groups. The study will also help us come up with predictive models for high risk febrile neutropenia with increased risk of mortality. This understanding will help us develop specific interventions and shape antibiotic policies.
|