A study to assess the benefit of using growth factors in addition to antibiotics in children with febrile neutropenia

A randomized open labeled parallel group phase III study of antibiotics alone versus antibiotics plus granulocyte-colony-stimulating factor in pediatric patients with chemotherapy induced febrile neutropenia in a developing country.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000177

Enrollment

200

Registered

2010-03-09

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: null- Haematologic malignancies and solid tumors in pediatric cancer patients having chemotherapy induced febrile neutropenia.

Interventions

Intervention1: G-CSF SQ: 5mcg/kg/day Control Intervention1: No G-CSF beginning within 24 hours of empiric antibiotic therapy.: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: Subjects admitted for fever and chemotherapy -induced neutropenia who have been on protocols that do not utilize prophylactic G-CSF will be eligible.Patients must present with an acute onset of fever of equal to or greater than 38.3 degrees celcius and absolute neutrophil count <500 /meu l

Exclusion criteria

Exclusion criteria: 1.patients with acute myelogenous leukemia and myelodysplastic syndrome. 2.Patients with septic shock. 3.Patients treated with IV anitbiotics within 7 days 4.Prolonged fever of unknown origin in patients who have undergone standard fever evaluation. 5.Patients could have been treated with growth factors in the past, but all patients who are being treated with any haemopoetic growth factors.eg G-CSF, GM -CSF at the time of study entrygrowth factors 6.ALL patients on induction or not in remission after induction 7.Patients with renal impairment:serum creatinine equal to or higher than 1.5 x normal. 8.Patients who have had radiotherapy to marrow reserves.i.e craniospinal and and /or pelvic irradiation 9.Solid tumor patients with bone marrow involvement

Design outcomes

Primary

Measure	Time frame
-Time to resolution of Febrile Neutropenia. -Time to resolution of neutropenia -Time to resolution of fever -Days of hospitalisation for febrile neutropenia -Duration of IV and /PO Antimicrobial Therapy for febrile neutropenia Incidence of Complications related to febrile neutropenia -Cost of therapy.Timepoint: NA	—

Secondary

Measure	Time frame
The incidence of the change of the initial empiric antibiotic treatment.Timepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr Brijesh Arora

brijesharora@rediffmail.com02224177220

Outcome results

None listed

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