| 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
|
|
|
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
|
|
|
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 |