| CTRI Number |
CTRI/2010/091/000177 [Registered on: 09/03/2010] |
| Last Modified On: |
13/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
A study to assess the benefit of using growth factors in addition to antibiotics in children with febrile neutropenia
|
Scientific Title of Study
Modification(s)
|
A randomized open labeled parallel group phase III study of antibiotics alone versus antibiotics plus granulocyte-colony-stimulating factor in pediatric patients with chemotherapy induced febrile neutropenia in a developing country. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 659 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brijesh Arora |
| Designation |
|
| Affiliation |
|
| Address |
Department of Medical Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177220 |
| Fax |
02224146937 |
| Email |
brijesharora@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brijesh Arora |
| Designation |
|
| Affiliation |
|
| Address |
Department of Medical Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177220 |
| Fax |
02224146937 |
| Email |
brijesharora@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brijesh Arora |
| Designation |
|
| Affiliation |
|
| Address |
Department of Medical Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177220 |
| Fax |
02224146937 |
| Email |
brijesharora@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural funding |
| Intramural funding |
| NIL |
|
Primary Sponsor
Modification(s)
|
| Name |
Terry Fox Foundation |
| Address |
The Terry Fox Foundation
Suite 303, 46167 Yale Road
Chilliwack, BC
V2P 2P2
Tel: (604) 701-0246
Fax: (604) 701-0247
e-mail: national@terryfoxrun.org |
| Type of Sponsor |
Other [Non-profit International Organisation for cancer research] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Zydus Pharmaceuticals, Roche |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Brijesh arora |
Tata Memorial Hospital |
Dr E Borges Road,Parel-400012
Mumbai
MAHARASHTRA |
02224177220
02224146937
brijesharora@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee-II, Tata Memorial Hospital, Parel, Mumbai 400012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Haematologic malignancies and solid tumors in pediatric cancer patients having chemotherapy induced febrile neutropenia., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
G-CSF SQ |
5mcg/kg/day |
| Comparator Agent |
No G-CSF beginning within 24 hours of empiric antibiotic therapy. |
Not applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
Subjects admitted for fever and chemotherapy -induced neutropenia who have been on protocols that do not utilize prophylactic G-CSF will be eligible.Patients must present with an acute onset of fever of equal to or greater than 38.3 degrees celcius and absolute neutrophil count <500 /meu l |
|
| ExclusionCriteria |
| Details |
1.patients with acute myelogenous leukemia and myelodysplastic syndrome.
2.Patients with septic shock.
3.Patients treated with IV anitbiotics within 7 days
4.Prolonged fever of unknown origin in patients who have undergone standard fever evaluation.
5.Patients could have been treated with growth factors in the past, but all patients who are being treated with any haemopoetic growth factors.eg G-CSF, GM -CSF at the time of study entrygrowth factors
6.ALL patients on induction or not in remission after induction
7.Patients with renal impairment:serum creatinine equal to or higher than 1.5 x normal.
8.Patients who have had radiotherapy to marrow reserves.i.e craniospinal and and /or pelvic irradiation
9.Solid tumor patients with bone marrow involvement |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| -Time to resolution of Febrile Neutropenia.
-Time to resolution of neutropenia
-Time to resolution of fever
-Days of hospitalisation for febrile neutropenia
-Duration of IV and /PO Antimicrobial Therapy for febrile neutropenia
Incidence of Complications related to febrile neutropenia
-Cost of therapy. |
NA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The incidence of the change of the initial empiric antibiotic treatment. |
Not applicable |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/04/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chemotherapy causes neutropenia (low white cell count), which leads to infections and death.Human granulocytegrowth factors (GCSF) are used to increase the low white blood cell count after chemotherapy.GCSF has been shown to be useful in reducing the duration of fever with neutropenia, duration of antibiotic use and duration of hospital stay in adults in developing countries.
The morbidity and mortality associated with febrile neutropenia is higher in developing countries with much higher ambient infectious burden, crowding, poor nutrition, suboptimal infection control practices,and limited human resource and intensive care infrastructure required for care of such patients.It is likely that the benefit of reduction in the days of febrile neutropenia may be much more in developing countries and may be much more cost effective compared to developed countries.
There is currently no published well conducted randomized study addressing the role of GCSF in febrile neutropenia in children in developing countries.Therefore,we attempt to determine whether GCSF administered in addition to empiric antibiotic therapy is beneficial as well as cost -effective in febrile neutropenic pediatric patients in developing countries. |