Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129688
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : September 23, 2005
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by:
Khon Kaen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Once-daily dose administration of aminoglycoside in adults is effective and economical. However, its value in febrile neutropenic children, especially in Thailand, is less well researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic children is low, the combination of cloxacillin and amikacin is an appropriate approach. This study would like to compare the efficacy and safety including cost between these two amikacin administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical therapy in febrile neutropenic children.

Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic children in Khon Kaen, Thailand.


Condition or disease Intervention/treatment Phase
Neutropenia Cancer Fever Drug: cloxacillin and amikacin (once or twice daily dosage) Not Applicable

Detailed Description:

Fever: a single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour.

Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm3.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children
Study Start Date : April 2002
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Afebrile within 5 days of the initial treatment regimen
  2. Nephrotoxicity and ototoxicity

Secondary Outcome Measures :
  1. Cost difference
  2. Pharmacokinetic parameters of amikacin in these children

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 1 year - 14 years
  • A single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour.
  • Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm3.
  • During the course of chemotherapy

Exclusion Criteria:

  • History of amikacin or cloxacillin allergy
  • Creatinine clearance < 30 ml/min/m2
  • Central nervous system infection: meningitis or brain abscess
  • History of hearing abnormality
  • Severely ill: shock
  • Chronic liver diseases or SGPT > 10 times of upper normal limit
  • Received aminoglycoside within 14 days prior to enrolment
  • Received any intravenous antibiotics within 7 days
  • Cancer which is newly diagnosed or relapsed
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129688


Sponsors and Collaborators
Khon Kaen University
National Research Council of Thailand
Investigators
Layout table for investigator information
Principal Investigator: Pope - Kosalaraksa, M.D. Faculty of Medicine, Khon Kaen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00129688    
Other Study ID Numbers: HE44290
40/2545
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: September 23, 2005
Last Verified: February 2005
Keywords provided by Khon Kaen University:
febrile neutropenia
once-daily
amikacin
cloxacillin
children
Additional relevant MeSH terms:
Layout table for MeSH terms
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
 Amikacin
Cloxacillin
Anti-Bacterial Agents
Anti-Infective Agents