The Tobramycin Study

Tracking Information
First Submitted Date ICMJE	November 22, 2005
First Posted Date ICMJE	November 23, 2005
Last Update Posted Date	July 6, 2011
Study Start Date ICMJE	September 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: November 22, 2005)	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; (submitted: November 22, 2005)	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	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
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; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Neutropenia; Fever; Cancer
Intervention ICMJE	Drug: Tobramycin once a day
Study Arms	Not Provided
Publications *	Not Provided
* 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; (submitted: November 22, 2005)	210
Original Enrollment ICMJE	Same as current
Study Completion Date	March 2005
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Febrile neutropenia Cancer Adult (16-70) Signed informed consent
Sex/Gender	Sexes Eligible for Study: All
Ages	16 Years to 70 Years (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00257790
Other Study ID Numbers ICMJE	Tobrax1; 01-06850; 8560; 2016
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
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; The Hospital of Vestfold; Sykehuset Asker og Baerum
Investigators ICMJE	Principal Investigator: Dag Torfoss, MD Oslo University Hospital
PRS Account	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