Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

September 22, 2005 updated by: Khon Kaen University

Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

166

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Afebrile within 5 days of the initial treatment regimen
Nephrotoxicity and ototoxicity

Secondary Outcome Measures

Outcome Measure
Cost difference
Pharmacokinetic parameters of amikacin in these children

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Collaborators

National Research Council of Thailand

Investigators

  • Principal Investigator: Pope - Kosalaraksa, M.D., Faculty of Medicine, Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

June 1, 2004

Study Registration Dates

First Submitted

August 10, 2005

First Submitted That Met QC Criteria

August 10, 2005

First Posted (Estimate)

August 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 23, 2005

Last Update Submitted That Met QC Criteria

September 22, 2005

Last Verified

February 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE44290
  • 40/2545

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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