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CTRI Number  CTRI/2018/10/016073 [Registered on: 18/10/2018] Trial Registered Prospectively
Last Modified On: 08/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A study to look for the usefulness of BAL test in blood cancer patients with pneumonia.  
Scientific Title of Study   A prospective observational study to evaluate the clinical utility of staged Broncho alveolar fluid (BAL) analysis in adolescent and adult leukemia and lymphoma patients with febrile neutropenia and lung infiltrates. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hasmukh Jain 
Designation  Assistant Professor, Medical Oncology E 
Affiliation  Tata Memorial Centre 
Address  Room No.81, Main Building, Adult Haematolymphoid Deparment, Medical Oncology Division, Tata Memorial Hospital Dr.E Borges road, Parel Mumbai, 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hasmukh Jain 
Designation  Assistant Professor, Medical Oncology E 
Affiliation  Tata Memorial Centre 
Address  Room No.81, Main Building, Adult Haematolymphoid Department, Medical Oncology Division, Tata Memorial Hospital, Dr.E Borges road, Parel Mumbai, 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sweta Bothra 
Designation  Junior Resident, Radio diagnosis 
Affiliation  Tata Memorial Centre 
Address  Room No. 64, Main Building, Department of Radiodiagnosis, Tata Memorial Hospital, Dr.E Borges road, Parel Mumbai, 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  sweta.bothra1@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre Research Administrative Council, Clinical Research Secretariat, 3rd Floor, Main Building, Tata Memorial Hospital, Dr.E.Borges Road, Parel, Mumbai, 400012  
 
Primary Sponsor  
Name  Tata Memorial Centre Research Administrative Council 
Address  Clinical Research Secretariat 3rd Floor Main Building, Tata Memorial Hospital Dr. E. Borges Road, Parel Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hasmukh Jain  Tata Memorial Centre  Room No.81, Adult Haematolymphoid Department, Medical Oncology Division, Main Building Tata Memorial Hospital, Dr.E Borges road, Parel Mumbai 400012
Mumbai
MAHARASHTRA 
2224177000

dr.hkjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C91||Lymphoid leukemia, (2) ICD-10 Condition: C920||Acute myeloblastic leukemia, (3) ICD-10 Condition: C889||Malignant immunoproliferative disease, unspecified, , (4) ICD-10 Condition: C829||Follicular lymphoma, unspecified, (5) ICD-10 Condition: C819||Hodgkin lymphoma, unspecified, (6) ICD-10 Condition: C939||Monocytic leukemia, unspecified, (7) ICD-10 Condition: C948||Other specified leukemias, (8) ICD-10 Condition: C851||Unspecified B-cell lymphoma, (9) ICD-10 Condition: C852||Mediastinal (thymic) large B-celllymphoma, (10) ICD-10 Condition: C858||Other specified types of non-Hodgkin lymphoma, (11) ICD-10 Condition: C859||Non-Hodgkin lymphoma, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients aged more than or equal to 15years
Leukemia and lymphomas on chemotherapy
Febrile neutropenia
Lung infiltrates on chest x-ray or CT chest

 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The proportion of patients with a confirmed microbiological diagnosis using staged BAL analysis  24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
a) The proportion of patients who have a change in antimicrobial therapy.
b) The feasibility of doing a Bronchoscopy.
c) The proportion of patients who develop major or minor complications during the procedure.
d) The 4 and 12week clinical and radiological outcomes.
e) The 30-day mortality rates.
f) Correlation between radiological and etiological findings.

 
1)4th week
2)30th Day
3)12th week 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   24/10/2018 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Febrile neutropenia (FN) is an important complication while on chemotherapy in patients with hematological malignancies. Lung infiltrates (LI) are seen in 30% of patients with FN. The prevalence of LI depends on the duration of neutropenia, underlying malignancy and the imaging modality used (CT chest being more sensitive as compared to Chest X rays). Patients of FN with LI have a higher mortality. A wide spectrum of organisms can cause LI in this setting and includes bacterial, fungal, viral or poly-microbial infections. Treatment is mostly empirical and usually consists of a combination of antibiotics that cover Enterobacteriaceae and Pseudomonas (Such as Cefoperazone-sulbactam or carbapenems) with an aminoglycoside and an agent that act against staphylococcal aureus (Teicoplanin or vancomycin). The addition of antifungal is considered if fever persists beyond 96 hours as per the IDSA guidelines. The antibiotics are continued for at least 10-14 days and in the case of an antifungal for throughout the duration of myelosuppression and resolution of radiological findings. The radiological findings are non-specific. Other non-invasive tests such as blood cultures and serum galactomannan help in guiding therapy in <30% patients. An accurate etiological diagnosis is essential and could help in narrowing down the use of antimicrobials, thereby improving the efficacy, preventing toxicity and emergence of drug resistance. Bronchoscopy is an important diagnostic tool that has a diagnostic yield reported in the range of 25-50%. These studies have been mainly retrospective in nature and used a varied microbiologic algorithm. The studied population has also been very heterogeneous precluding any firm conclusion on its clinical utility. This also has to be looked at in the context that most of the FN patients have a higher risk of complications such as bleeding (due to thrombocytopenia and coagulopathy) due to the procedure. These patients are also sick and could be dependent on high flow oxygen or hemodynamically unstable thereby making them unsuitable for this procedure. We routinely perform BAL analysis on patients of FN with LI and use a microbiologic algorithm tapered to the clinical presentation and radiological findings and have found it very useful. The exact clinical utility and feasibility of this test need to be studied in a prospective manner, we propose to do in our study.
 
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