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

November 22, 2005
July 3, 2011
September 2001
Not Provided
Resolution of fever and signs of infection without modification of the antibiotic regimen
Same as current
Complete list of historical versions of study NCT00257790 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Tobramycin Study
Tobramycin én Gang Daglig Mot Tre Ganger Daglig, Gitt Med Benzylpenicillin, Til Pasienter Med nøytropen Feber

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neutropenia
  • Fever
  • Cancer
Drug: Tobramycin once a day
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
March 2005
Not Provided

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

Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00257790
Tobrax1, 01-06850, 8560, 2016
Not Provided
Not Provided
Oslo University Hospital
  • 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
Principal Investigator: Dag Torfoss, MD Oslo University Hospital
Oslo University Hospital
November 2005

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