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NCT00003739 · ClinicalTrials.gov registry record · Phase 3

Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy

A Phase 3 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 3
Development phase
67
Enrollment target

NCT00003739: Completed Phase 3 study, sponsored by Children's Oncology Group.

NCT00003739 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 67 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003739, a Phase 3 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
67 participants
Enrollment target

Study Summary

RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus G-CSF is more effective than antibiotic therapy alone for treating side effects caused by chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with or without G-CSF in treating children who have neutropenia and fever that are caused by chemotherapy.

Primary Outcome

Time to Resolution of Febrile Neutropenia (Days of antibiotic treatment until the resolution of febrile neutropenia): The time to resolution of febrile neutropenia is defined as the number of days elapsed before the first day with both a temperature of less than 38.0oC and an ANC of equal to or greater than 500/μL.

Interventions

  • BIOLOGICAL filgrastim

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 1999-03
Est. Completion 2006-09
Phase Phase 3
Children's Oncology Group

342 total trials

What the finished NCT00003739 record still lists

NCT00003739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 1 intervention - of which filgrastim is the first listed.

NCT00003739 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00003739 about?

NCT00003739 is a clinical study titled "Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy". RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemo...

What is the current status of trial NCT00003739?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 1999-03. Estimated completion is 2006-09.

What interventions are being tested in trial NCT00003739?

The interventions under investigation include: filgrastim (BIOLOGICAL).

Who is sponsoring clinical trial NCT00003739?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00003739's enrollment target sits among peer trials

67 1796th of 2000 higher than 204 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00003739, the US trial registry maintained by the National Library of Medicine. NCT00003739 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.