ClinicalTrials.gg
Not yet recruitingNCT06988826AGF-FNUpdated May 25, 2025

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

A Phase 4 interventional study of G-CSF and Antibiotics only in Febrile Neutropenia, Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy and Febrile Neutropenia, Drug-Induced, sponsored by King Edward Medical University. Not yet recruiting. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by King Edward Medical University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
1 Year to 16 Years
Sex
All
01

Study summary

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.

02

Conditions studied

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

Browse trials for

Keywords

  • febrile neutropenia
  • chemotherapy-induced febrile neutropenia
  • Antibiotics
  • G-CSF
03

In context

Febrile Neutropenia

147 studies on the registry are indexed under Febrile Neutropenia; 36 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 95 interventional studies indexed under Febrile Neutropenia.

Browse Febrile Neutropenia studies →

Lead sponsor

King Edward Medical University is the lead sponsor of 84 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Non-neutropenic fever
  • already received G-CSF or antibiotics before presenting to hospital
  • any other cause of neutropenia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Group 1

    G-CSF plus antibiotic therapy

    Drug: G-CSF

  • Active comparator
    Group 2

    Antibiotic Therapy

    Drug: Antibiotics only

Interventions

  • DrugG-CSF

    G-CSF \& Antibiotic therapy in combination

  • DrugAntibiotics only

    Antibiotics alone

06

What researchers measure

Primary outcomes

  1. Resolution of FN

    Duration of resolution of febrile neutropenia (in days)

    Time frame: 2 weeks

Secondary outcomes

  1. Afebrile

    Duration of resolution of fever (in days)

    Time frame: 2 weeks

  2. Length of hospital stay

    Length of hospital stay (in days)

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Data dictionary will be made available on request

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2025; primary completion for May 2026, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2025
First posted
May 25, 2025
StartEst.
Jun 1, 2025
Primary completionEst.
May 31, 2026
CompletionEst.
Dec 2026
Last update
May 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06988826
Lead sponsor
King Edward Medical University
Collaborators
University of Child Health Sciences and Children's Hospital, Lahore
Responsible party
Sidrah Lodhi (Assistant Professor of Endocrinology, King Edward Medical University) — Principal investigator
First posted
May 25, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
May 31, 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 25, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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