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Implementing an empirical antibiotic discontinuation strategy

Implementing an empirical antibiotic discontinuation strategy in adult haematological malignancies with high-risk febrile neutropenia without identifiable focus: a Pilot Study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074088
Enrollment
30
Registered
2024-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C920- Acute myeloblastic leukemia

Interventions

Intervention1: Empirical antibiotic discontinuation strategy in patients with high risk febrile neutropenia: Empirical antibiotic discontinuation strategy in patients with high-risk febrile neutropeni

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 focusTimepoint: 72 hour—

Secondary

MeasureTime frame
EAT-free duration (assuming that the antibiotics would have been continued till neutrophil recovery of 500 cu mm).Timepoint: 7 DAYS;Proportion with complications (hypotension leading to fluid bolus or ICU admission on therapy or within 7 days of antibiotic discontinuation)Timepoint: 7 DAYS;Proportion with morbidity (either a relapse of fever or development of new infection within 7 days of antibiotic discontinuation)Timepoint: 7 DAYS;To assess the 30-day mortalityTimepoint: 30 DAYS;Utility of biomarkers (Procalcitonin) in the discontinuation of antibioticsTimepoint: 2 DAYS—

Countries

India

Contacts

Public ContactVAIDYA VEDANT SHRIPAD

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)

swami5590@gmail.com8376817998

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026