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NCT Number: NCT06988826

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

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

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Key information

Conditions

Febrile Neutropenia Agranulocytosis Antibiotic Therapy Chemotherapy-Induced Febrile Neutropenia Cytopenia Febrile Neutropenia, Drug-Induced Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy G-CSF Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G-CSF

Drug

G-CSF & Antibiotic therapy in combination

Antibiotics only

Drug

Antibiotics alone

Primary outcomes

  1. Resolution of FN

    Time frame: 2 weeks

    Duration of resolution of febrile neutropenia (in days)

Secondary outcomes

  1. Afebrile

    Time frame: 2 weeks

    Duration of resolution of fever (in days)

  2. Length of hospital stay

    Time frame: 2 weeks

    Length of hospital stay (in days)

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: AGF-FN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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