FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074088 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Implementing an empirical antibiotic discontinuation strategy 
Scientific Title of Study   Implementing an empirical antibiotic discontinuation strategy in adult haematological malignancies with high-risk febrile neutropenia without identifiable focus: a Pilot Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SWAMINATHAN K 
Designation  ASSISTANT PROFESSOR 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) 
Address  Department of medical oncology, 3rd Floor SSB JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  8376817998  
Fax    
Email  swami5590@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SWAMINATHAN K 
Designation  ASSISTANT PROFESSOR 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) 
Address  Department of Medical Oncology, 3rd Floor Super Specialty Block JIPMER, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8376817998  
Fax    
Email  swami5590@gmail.com  
 
Details of Contact Person
Public Query
 
Name  VAIDYA VEDANT SHRIPAD 
Designation  SENIOR RESIDENT 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) 
Address  Department of Medical Oncology, 3rd Floor Super Specialty Block JIPMER, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9585723902  
Fax    
Email  vedantvaidya321@gmail.com  
 
Source of Monetary or Material Support  
Intra Mural Research fund Committe,JIPMER, Puducherry, 605006 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER, PUDUCHERRY 
Type of Sponsor  Government medical college 
 
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 SWAMINATHAN K  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), PUDUCHERRY  Department of Medical Oncology, 3rd Floor Super Specialty Block JIPMER, Pondicherry
Pondicherry
PONDICHERRY 
08376817998

swami5590@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C920||Acute myeloblastic leukemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  no drug  Discontinuation of empirical antibiotics in adult hematological malignancies with high risk febrile neutropenia without focus. TOTAL DURATION OF THERAPY - 7 Days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients with adult haematological malignancies, aged 18 years
and above, with high-risk febrile neutropenia (expected ANC < 100)
without focus on first-line antibiotic therapy admitted under medical
oncology department, JIPMER. 
 
ExclusionCriteria 
Details  Previous enrolment on the trial
• Age greater than or equal to 70 years
• Patients who required therapeutic anti-fungals during febrile
neutropenia
• Patients who required more than first line (cefoperazone-
sulbactam + amikacin, levofloxacin or any oral antibiotics) and
second line antibiotics (cefoperazone-
sulbactam+meropenem/imipenem+teicoplanin/clindamycin)
• Patients who required inotropic support/mechanical
ventilation during treatment course for febrile neutropenia
• Severe renal function impairment (defined as creatinine
clearance below 30 ml/ min)
• Clinical or microbiological or radiologic focus of infection
• Patient undergone stem cell transplant 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the number of successful episodes of discontinuation of
empirical antibiotic therapy among haematological malignancy
patients with high-risk febrile neutropenia (expected ANC 100)
without focus 
72 hour 
 
Secondary Outcome  
Outcome  TimePoints 
EAT-free duration (assuming that the antibiotics would have
been continued till neutrophil recovery of 500 cu mm). 
7 DAYS 
Proportion with morbidity (either a relapse of fever or
development of new infection within 7 days of antibiotic
discontinuation) 
7 DAYS 
Proportion with complications (hypotension leading to fluid
bolus or ICU admission on therapy or within 7 days of
antibiotic discontinuation) 
7 DAYS 
To assess the 30-day mortality  30 DAYS 
Utility of biomarkers (Procalcitonin) in the discontinuation of
antibiotics 
2 DAYS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/09/2024 
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  

Febrile neutropenia is a common complication arising in cancer patients during course of chemotherapy. Febrile neutropenia poses a significant challenge in the management of high-risk patients, often requiring broad-spectrum antibiotic therapy.1 The choice of agents are modified as further investigations reveal any specific organism and, or depending on the clinical assessment of the patient. In a large number of cases, no definite focus of infection can be identified. The optimal management approach (duration or inpatient /outpatient setting) is still debatable.

It is quite common practice to continue empirical antimicrobial therapy (EAT) until neutrophil recovery which could prolong the therapy unnecessarily. 2

Optimization of antimicrobial therapy is necessary in an era of growing antimicrobial resistance, particularly important in management of patients with hematological malignancies on chemotherapy as they are often exposed to the collateral damage of prolonged broad-spectrum antimicrobial therapy including drug toxicity and predisposition to fungal infections and Clostridium difficile-associated diarrhea.3,4,5

To reduce side effects, antibiotic selective pressure on the human microbiota, and antimicrobial resistance development, a more rational use of antibiotics is necessary. 6

Therefore, if safe, stopping antibiotic therapy earlier in patients without signs of a bacterial infection could provide significant benefits.

We aimed to establish whether discontinuation of EAT driven by an integrated approach regardless of neutrophil recovery would optimize the duration of antibiotic therapy.

 

Rationale: The extended use of antibiotics contributes to:

1.      Antimicrobial resistance

2.      Adverse effects

3.      Ineffective man-hour usage especially in low resource setting

4.      Excessive cost

Hence, we want to explore antibiotic discontinuation policy in high-risk febrile neutropenia without focus in adult malignancy.

 

Novelty: Paucity of prospective studies assessing safety of discontinuation of antibiotics in high-risk febrile neutropenia cases in Indian settings among adult patients with malignancy 
Close