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A Clinical trial to evaluate the safety of early discontinuation of antibiotics in children with cancer and infections based on procalcitonin levels

Safety of Procalcitonin Guided Discontinuation of Antibiotic Therapy among Children Receiving Cancer Chemotherapy and Having Low Risk Febrile Neutropenia â?? A Randomized Non-Inferiority Trial - ProFenC Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022997
Enrollment
140
Registered
2020-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 discontinuation of empirical anibiotics: Children with low risk febrile neutropenia without any identified focus will be started on IV antibiotics as per inst

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1. Being treated for febrile neutropenia with empirical antibiotics 2. With afebrile period for at least 24 hours 3. With sterile blood culture at 48 hours 4. With negative or normalization of procalcitonin at 48 hours 5. Written informed consent

Exclusion criteria

Exclusion criteria: Exclusion Criteria during screening 1. Children receiving intensive phases of chemotherapy 2. Clinically documented infections which require prolonged duration of antibiotics viz., osteomyelitis, septic arthritis, meningitis, endocarditis, pneumonia, neutropenic enterocolitis etc. 3. Children whose malignancy is not in remission 4. Children with grade-3 and grade-4 mucositis 5. Children with profound neutropenia ANC 6. Severe organ dysfunction defined by Oxygen requirement >50% FiO2, mechanical ventilation, hemodynamic compromise requiring inotropes/vasoactives, serum creatinine >= 2 x ULN for age or 2-fold increase from baseline, SGOT/SGPT 2 X ULN for age, total bilirubin >= 4 mg/dL, GCS = 3 points from baseline 7. Patients undergoing hematopoietic stem cell transplantation (HSCT) Exclusion criteria during randomization at 72-hours 1. Non availability of reliable and compliant caretaker 2. Residence >1 hour of reach from the hospital

Design outcomes

Primary

MeasureTime frame
â?¢ Any recurrence of fever or any clinical signs/symptoms of infection relapse requiring restarting/upgradation of Antibiotics â?¢ Need for hospitalization due to infectious etiology â?¢ Death due to infectious etiology Timepoint: 14 days from randomization—

Secondary

MeasureTime frame
1. To compare the duration of antibiotic exposure between the two groupsTimepoint: 14 days from randomization;2. To assess the difference in all-cause mortality between the two groups Timepoint: 28 days from randomization—

Countries

India

Contacts

Public ContactPrasanth S

AIIMS

drjpmeena@gmail.com8890139358

Outcome results

None listed

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