| 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 |
|
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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 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 |
|
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Regulatory Clearance Status from DCGI
|
|
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, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
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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 |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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 |
|
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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)?
|
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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. |