NCT00257790

Brief Summary

Evaluate if tobramycin given once a day is at least as efficacious as the traditional tobramycin given three times a day, given with penicillin G, til patients with febrile neutropenia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
Last Updated

July 6, 2011

Status Verified

November 1, 2005

First QC Date

November 22, 2005

Last Update Submit

July 3, 2011

Conditions

NeutropeniaFeverCancer

Keywords

FeverNeutropeniaTobramycinAminoglycosidePenicillin

Outcome Measures

Primary Outcomes (1)

  • Resolution of fever and signs of infection without modification of the antibiotic regimen

Secondary Outcomes (8)

  • Hours to defervescence

  • Days to treatment failure

  • 30 days mortality

  • Nephrotoxicity

  • Other side effects

  • +3 more secondary outcomes

Interventions

Tobramycin once a dayDRUG

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Febrile neutropenia Cancer Adult (16-70) Signed informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

NeutropeniaFeverNeoplasms

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dag Torfoss, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 23, 2005

Study Start

September 1, 2001

Study Completion

March 1, 2005

Last Updated

July 6, 2011

Record last verified: 2005-11