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
  Purpose

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.


Condition Intervention Phase
Neutropenia
Fever
Cancer
Drug: Tobramycin once a day
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tobramycin én Gang Daglig Mot Tre Ganger Daglig, Gitt Med Benzylpenicillin, Til Pasienter Med nøytropen Feber

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Resolution of fever and signs of infection without modification of the antibiotic regimen

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 210
Study Start Date: September 2001
Estimated Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257790

Sponsors and Collaborators
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
Investigators
Principal Investigator: Dag Torfoss, MD Oslo University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00257790     History of Changes
Other Study ID Numbers: Tobrax1, 01-06850, 8560, 2016
Study First Received: November 22, 2005
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Fever
Neutropenia
Tobramycin
Aminoglycoside
Penicillin

Additional relevant MeSH terms:
Fever
Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014