Stoppage of antibiotics at clinical improvement in pediatric cancer patients with high risk febrile neutropenia â?? A randomized clinical study

Early stoppage of empirical antibiotic therapy at clinical improvement in pediatric cancer patients with high risk febrile neutropenia â?? A randomized open label clinical trial

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/015994

Enrollment

250

Registered

2018-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: C959- Leukemia, unspecified

Interventions

Intervention1: ARM A: Empirical antibiotic therapy discontinuation will occur when the patient is afebrile, with resolution of signs, symptoms and test abnormalities and normalization of vital signs f

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 2-18 years 2. AML and ALL Induction and re-induction with febrile neutropenia 3. Blood culture taken prior or within 24 hrs of start of anti-microbial therapy 4. Giving consent

Exclusion criteria

Exclusion criteria: 1. Already enrolled once in previous episode 2. Retroviral positive patients 3. Patients who required therapeutic anti-fungals during febrile neutropenia 4. 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) 5. Patients who required inotropic support/mechanical ventilation during treatment course for febrile neutropenia 6. Severe renal function impairment (defined as creatinine clearance below 30 ml/ min) 7. Clinical or microbiological or radiologic focus of infection 8. Patient undergone stem cell transplant

Design outcomes

Primary

Measure	Time frame
Recurrent feverTimepoint: daily until 35 days of start of chemotherapy	—

Secondary

Measure	Time frame
Adverse events (Nausea, vomiting)Timepoint: Daily until day 35 from start of chemotherapy;Antibiotic durationTimepoint: Until Day 35 of start of chemotherapy;MortalityTimepoint: Until Day 35 of start of chemotherapy;Procalcitonin levelTimepoint: At onset of fever At stoppage of antibiotics At neutrophils 500/mm3 At Recurrance of fever;Re-admission rate Timepoint: Until Day 35 of start of chemotherapy;Renal dysfunctionTimepoint: Alternate day until day 35 of start of chemotherapy;Requirement of third line antibiotics and therapeutic anti-fungalTimepoint: Until Day 35 of start of chemotherapy	—

Measure

Time frame

Adverse events (Nausea, vomiting)Timepoint: Daily until day 35 from start of chemotherapy;Antibiotic durationTimepoint: Until Day 35 of start of chemotherapy;MortalityTimepoint: Until Day 35 of start of chemotherapy;Procalcitonin levelTimepoint: At onset of fever At stoppage of antibiotics At neutrophils 500/mm3 At Recurrance of fever;Re-admission rate Timepoint: Until Day 35 of start of chemotherapy;Renal dysfunctionTimepoint: Alternate day until day 35 of start of chemotherapy;Requirement of third line antibiotics and therapeutic anti-fungalTimepoint: Until Day 35 of start of chemotherapy

—

Countries

India

Contacts

Public ContactSantosh Kumar C

AIIMS NEW DELHI

sambakh@hotmail.com9958828763

Outcome results

None listed

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