Febrile NeutropeniaPhase 4AGF-FNNCT06988826
Comparison of G-CSF & Antibiotics Versus Antibiotics Alone in Resolution of Febrile Neutropenia
A Phase 4 study testing G-CSF and Antibiotics only in people with Febrile Neutropenia and Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy, run by King Edward Medical University.
Trial summary
This study aim to find the best option for children having cancer who develop low immunity state due to chemotherapy Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Febrile Neutropenia, Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy, Febrile Neutropenia, Drug-Induced
- What is being tested?
- G-CSF and Antibiotics only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-16 years
- any Gender
- Febrile neutropenia
- diagnosed case of solid or hematological malignancy
- taking chemotherapy
Who cannot join
- Non-neutropenic fever
- already received G-CSF or antibiotics before presenting to hospital
- any other cause of neutropenia
About this study
Official title: Comparison of Antibiotics With and Without Granulocyte Colony-Stimulating Factor in Children With Chemotherapy Induced Febrile Neutropenia
This study aim to find the best option for children having cancer who develop low immunity state due to chemotherapy
Read the 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.
- Conditions
- Febrile Neutropenia, Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy, Febrile Neutropenia, Drug-Induced, G-CSF, Antibiotic Therapy
- Being tested
- G-CSF, Antibiotics only
- Keywords
- febrile neutropenia, chemotherapy-induced febrile neutropenia, Antibiotics, G-CSF
- Medical subject headings
- Febrile Neutropenia, Chemotherapy-Induced Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
G-CSF \& Antibiotic therapy in combination
Antibiotics onlyDrug
Antibiotics alone
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | G-CSF plus antibiotic therapy Receives: Drug: G-CSF |
| Group 2 | Active comparator | Antibiotic Therapy Receives: Drug: Antibiotics only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of FN
Duration of resolution of febrile neutropenia (in days)
Measured: 2 weeks
Secondary outcomes (2)
Afebrile
Duration of resolution of fever (in days)
Measured: 2 weeks
Length of hospital stay
Length of hospital stay (in days)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Child Health Sciences and Children's Hospital, Lahore
- Responsible party
- Principal investigator, Sidrah Lodhi, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988826
- Sponsor's protocol ID
- 656/CH-UCHS/15/5/2023
- Acronym
- AGF-FN
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data dictionary will be made available on request