Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neutropenia Cancer Fever

Keywords

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febrile neutropenia once-daily amikacin cloxacillin children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cloxacillin and amikacin (once or twice daily dosage)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Pope - Kosalaraksa, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Khon Kaen University

Other Identifiers

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40/2545

Identifier Type: -

Identifier Source: secondary_id

HE44290