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

NCT06988826 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 656/CH-UCHS/15/5/2023
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Resolution of FN

  Duration of resolution of febrile neutropenia (in days)

  2 weeks

Secondary Outcomes (2)

• Afebrile

  2 weeks

• Length of hospital stay

  2 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

G-CSF plus antibiotic therapy

Drug: G-CSF

Group 2

ACTIVE COMPARATOR

Antibiotic Therapy

Drug: Antibiotics only

Interventions

G-CSF DRUG

G-CSF \& Antibiotic therapy in combination

Group 1

Antibiotics only DRUG

Antibiotics alone

Group 2

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Edward Medical University: lead
• University of Child Health Sciences and Children's Hospital, Lahore: collaborator

MeSH Terms

Conditions

Febrile Neutropenia; Chemotherapy-Induced Febrile Neutropenia

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Endocrinology

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL