A clinical trial to evaluate safety of early de-escalation of antibiotics in children with cancer based on procalcitonin levels

Comparative study of procalcitonin guided early de-escalation versus conventional antimicrobial therapy in children with high-risk febrile neutropenia receiving cancer chemotherapy - Nil

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095526

Enrollment

Registered

2025-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Procalcitonin Guided early de-escalation of empirical antibiotics: Children with high-risk febrile neutropenia will be admitted and started on iv antibiotics which usually includes comb

5years :8-10 mg/kg/day OD).Oral antibiotics will be continued until recovery of neutropenia i.e., ANC 500/microliter. Control Intervention1: Standard therapy: Control arm Standard therapy with contin

Eligibility

Inclusion criteria

Inclusion criteria: All children aged 3-14 years with hematolymphoid malignancies (ALL on Intensive phase of chemotherapy, AML, NHL) on chemotherapy and presenting with high- risk Febrile neutropenia, started on empirical antimicrobial therapy will be enrolled at 96 hours of presentation when they fulfill the following criteria -Sterile blood culture at 48 boursNegative Procalcitonin value (less than 0.5ng/ml) or more than 80% reduction in Procalcitonin value from baseline at 72 hours. 4. With an afebrile period for at least 24 hours (without antipyretics)No evidence of marrow recovery (Absolute Neutrophil Counts less than 500 per microliter)

Exclusion criteria

Exclusion criteria: 1. 2. 3. Hemodynamically unstable at time of presentation Clinically documented infections/sepsis which require prolonged duration of antibiotics like pneumonia, septic arthritis, meningitis, osteomyelitis, Neutropenic enterocolitis.Microbiological evidence of infection (Blood culture showing growth of microorganism)4. Radiological evidence of any focus of infection

Design outcomes

Primary

Measure	Time frame
To assess the recurrence of fever within first 10 days of being afebrile after discharge among children receiving cancer chemotherapy and being treated for high risk febrile neutropeniaTimepoint: Every 48 hours till 10 days of being afebrile after discharge or as per scheduled visits for chemotherapy or if danger signs appear	—

Secondary

Measure	Time frame
To compare the mean duration ofantibiotic exposure between the two groups To compare the mean duration taken for ANC recovery (more than 500/microliter) between the two groups. To compare the all-cause mortality between the two groups To study the prognostic value of -Procalcitonin (PCT) levelsProcalcitonin (PCT), quantitative C-C- Reactive protein Reactive Protein (CRP) in Febrile Neutropenia.Timepoint: First 10 days of being afebrile	—

Measure

Time frame

To compare the mean duration ofantibiotic exposure between the two groups To compare the mean duration taken for ANC recovery (more than 500/microliter) between the two groups. To compare the all-cause mortality between the two groups To study the prognostic value of -Procalcitonin (PCT) levelsProcalcitonin (PCT), quantitative C-C- Reactive protein Reactive Protein (CRP) in Febrile Neutropenia.Timepoint: First 10 days of being afebrile

—

Countries

India

Contacts

Public ContactAditi Sharma

Professor and Head of Department, Department of Pediatrics

drpkdebata@gmail.com7291000664

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026