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

NCT ID: NCT06988826

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

G-CSF plus antibiotic therapy

Group Type EXPERIMENTAL

G-CSF

Intervention Type DRUG

G-CSF \& Antibiotic therapy in combination

Group 2

Antibiotic Therapy

Group Type ACTIVE_COMPARATOR

Antibiotics only

Intervention Type DRUG

Antibiotics alone

Interventions

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G-CSF

G-CSF \& Antibiotic therapy in combination

Intervention Type DRUG

Antibiotics only

Antibiotics alone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Child Health Sciences and Children's Hospital, Lahore

OTHER

Sponsor Role collaborator

King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Sidrah Lodhi

Assistant Professor of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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656/CH-UCHS/15/5/2023

Identifier Type: -

Identifier Source: org_study_id

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