Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129688
• Other study ID #: HE44290
• Secondary ID: 40/2545
• Status: Completed
• Phase: N/A
• First received: August 10, 2005
• Last updated: September 22, 2005
• Start date: April 2002
• Est. completion date: June 2004

Study information

• Verified date: February 2005
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Fever
• Neutropenia

Intervention

Drug:
• cloxacillin and amikacin (once or twice daily dosage)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Khon Kaen University	National Research Council of Thailand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Afebrile within 5 days of the initial treatment regimen
Primary	Nephrotoxicity and ototoxicity
Secondary	Cost difference
Secondary	Pharmacokinetic parameters of amikacin in these children