Comparison of G-CSF & Antibiotics Versus Antibiotics Alon... | NCT06988826

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Estimated

Primary Completion Date

May 31, 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

May 14, 2025

First Submission Date that Met QC Criteria

May 23, 2025

First Posted Date

May 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2025

Last Update Posted Date

May 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sidrah Lodhi, Assistant Professor of Endocrinology, King Edward Medical UniversityPrincipal Investigator

Lead Sponsor

King Edward Medical UniversityOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	G-CSF plus antibiotic therapy	Drug: G-CSF
Group 2	Active Comparator	Antibiotic Therapy	Drug: Antibiotics only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G-CSF	Drug	G-CSF & Antibiotic therapy in combination	Group 1
Antibiotics only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of FN	Duration of resolution of febrile neutropenia (in days)	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Afebrile	Duration of resolution of fever (in days)	2 weeks
Length of hospital stay	Length of hospital stay (in days)	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data dictionary will be made available on request

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D064147	Febrile Neutropenia
D064146	Chemotherapy-Induced Febrile Neutropenia

ID	Term
D009503	Neutropenia
D000380	Agranulocytosis
D007970	Leukopenia
D000095542	Cytopenia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007960	Leukocyte Disorders

ID	Term
D016179	Granulocyte Colony-Stimulating Factor

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors