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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antibiotics With and Without Granulocyte Colony-Stimulating Factor in Children With Chemotherapy Induced Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT06988826
- Acronym / sponsor ID
- AGF-FN / 656/CH-UCHS/15/5/2023
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Collaborators
- University of Child Health Sciences and Children's Hospital, Lahore
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: G-CSFG-CSF plus antibiotic therapy |
| Group 2 | Active comparator | Drug: Antibiotics onlyAntibiotic Therapy |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 1-16 years
- any Gender
- Febrile neutropenia
- diagnosed case of solid or hematological malignancy
- taking chemotherapy
Key exclusion criteria (3 listed)
- Non-neutropenic fever
- already received G-CSF or antibiotics before presenting to hospital
- any other cause of neutropenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSFG-CSF \& Antibiotic therapy in combination | Drug | Group 1 |
| Antibiotics onlyAntibiotics alone | Drug | Group 2 |
Primary outcome
Resolution of FN
Time frame: 2 weeks
Duration of resolution of febrile neutropenia (in days)
2 secondary outcomes
Afebrile
Time frame: 2 weeks
Length of hospital stay
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes. Data dictionary will be made available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of FN (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.