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Comparison of G-CSF & Antibiotics Versus Antibiotics Alone in Resolution of Febrile Neutropenia

Comparison of Antibiotics With and Without Granulocyte Colony-Stimulating Factor in Children With Chemotherapy Induced Febrile Neutropenia

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06988826
Acronym
AGF-FN
Enrollment
150
Registered
2025-05-25
Start date
2025-06-01
Completion date
2026-12-31
Last updated
2025-05-25

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

Conditions

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

Keywords

febrile neutropenia, chemotherapy-induced febrile neutropenia, Antibiotics, G-CSF

Brief summary

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

Detailed 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.

Interventions

Antibiotics alone

DRUGG-CSF

G-CSF & Antibiotic therapy in combination

Sponsors

University of Child Health Sciences and Children's Hospital, Lahore
CollaboratorOTHER
King Edward Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Resolution of FN2 weeksDuration of resolution of febrile neutropenia (in days)

Secondary

MeasureTime frameDescription
Afebrile2 weeksDuration of resolution of fever (in days)
Length of hospital stay2 weeksLength of hospital stay (in days)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026