Comparison of G-CSF & Antibiotics Versus Antibiotics Alone in Resolution of Febrile Neutropenia (AGF-FN)

King Edward Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Febrile Neutropenia; G-CSF; Febrile Neutropenia, Drug-Induced; Antibiotic Therapy; Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy

Treatments: Drug: G-CSF; Drug: Antibiotics only

Study type: Interventional

Funder types: Other

Identifiers

NCT06988826

656/CH-UCHS/15/5/2023

Details and patient eligibility

About

This study aim to find the best option for children having cancer who develop low immunity state due to chemotherapy

Full description

Children having a cancer diagnosis and treated with chemotherapy often develop neutropenia. This creates an immunocompromised state which can result in infections manifested by fever. This study compares two treatment options to find out the best treatment for these patients.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 1-16 years
• any Gender
• Febrile neutropenia
• diagnosed case of solid or hematological malignancy
• taking chemotherapy

Exclusion criteria

• Non-neutropenic fever
• already received G-CSF or antibiotics before presenting to hospital
• any other cause of neutropenia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group 1

Experimental group

Description:

G-CSF plus antibiotic therapy

Treatment:

Drug: G-CSF

Group 2

Active Comparator group

Description:

Antibiotic Therapy

Treatment:

Drug: Antibiotics only