The Tobramycin Study

This study has been completed.

Sponsor:

Collaborators:

The National Institute of Health, Oslo

Ullevaal University Hospital

Sorlandet Hospital HF

Sykehuset Buskerud

Sentralsjukehuset i Rogaland

Sykehuset Innlandet HF

Sentralsjukehuset i Hedemark

Per Arne Standal, Sykehuset i Vestfold, Tønsberg

Ivar Jo Hagen, Sykehuset Innlandet, Lillehammer

Sykehuset Asker og Baerum

Information provided by:

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT00257790

First received: November 22, 2005

Last updated: July 3, 2011

Last verified: November 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

November 22, 2005

Last Updated Date

July 3, 2011

Start Date ^ICMJE

September 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00257790 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hours to defervescence
Days to treatment failure
30 days mortality
Nephrotoxicity
Other side effects
Pharmacokinetics of tobramycin in febrile neutropenic patients
Total antibiotic consumption
Cost-benefit of giving tobramycin once a day vs three times a day

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Tobramycin Study

Official Title ^ICMJE

Tobramycin én Gang Daglig Mot Tre Ganger Daglig, Gitt Med Benzylpenicillin, Til Pasienter Med nøytropen Feber

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.

Detailed Description

Prospective randomized Norwegian multicenter clinical trial (11 hospitals) comparing tobramycin given once a day (new regimen) vs. three times a day (current regimen), with penicillin G, to cancer patients with febrile neutropenia. Tobramycin half life and postantibiotic effect is at best 12 hours. It has been questioned if tobramycin once a day is safe in patients with low levels of granulocytes when it is given with a drug like penicillin G which is not covering Gram-negative rods. Treatment of febrile neutropenia with penicillin G and an aminoglycoside is standard of care in Norway, and it is probably a regimen that is promoting antimicrobial resistance less than a broad spectrum beta-lactam.

Cancer patients 16-70 with febrile neutropenia and signed informed consent could be randomized. Exclusion criteria were allergy to study medications, increased creatinine/renal failure, massive ascites, multiple myeloma, treatment with cis-platinum, recent therapy with aminoglycoside (4 weeks) or other antibiotics (4 days), hemodynamically unstable patients, pregnant and nursing patients.

Patients were stratified into three groups: Leukemia patients receiving intensive chemotherapy, lymphoma patients receiving high dose chemotherapy with autologous stem-cell support and other cancer patients.

Patients were randomized to either tobramycin once or three times a day. Once the patient was randomized and the first antibiotic dose was given, further antibiotic therapy was up to the patient's doctor's discretion (not blinded). Everybody received tobramycin 6 mg/kg/day and penicillin 5 mill. IE four times a day.

The patients were followed until all antibiotic therapy was terminated. Clinical condition and laboratory test results at time of randomization (new fever) was registered. Response to therapy, reason for modification of therapy, mortality, duration of neutropenia, maximum creatinine level, tobramycin serum concentrations, microbiological findings and total antibiotic consumption were registered.

After external monitoring of all the data the results are currently being made up and will be available for publication in 2006.

This trial has been conducted independently of the pharmaceutical industry. Grants have been received from The Norwegian Radium Hospital research fund, The Regional Health Authorities and The Norwegian Society for Infectious Diseases.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neutropenia
Fever
Cancer

Intervention ^ICMJE

Drug: Tobramycin once a day

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

210

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Febrile neutropenia Cancer Adult (16-70) Signed informed consent

Gender

Both

Ages

16 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT00257790

Other Study ID Numbers ^ICMJE

Tobrax1, 01-06850, 8560, 2016

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

The National Institute of Health, Oslo
Ullevaal University Hospital
Sorlandet Hospital HF
Sykehuset Buskerud
Sentralsjukehuset i Rogaland
Sykehuset Innlandet HF
Sentralsjukehuset i Hedemark
Per Arne Standal, Sykehuset i Vestfold, Tønsberg
Ivar Jo Hagen, Sykehuset Innlandet, Lillehammer
Sykehuset Asker og Baerum

Investigators ^ICMJE

Principal Investigator:

Dag Torfoss, MD

Oslo University Hospital

Information Provided By

Oslo University Hospital

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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