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Completed

NCT Number: NCT00129688

Once-Daily Amikacin Plus 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.

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Key information

Conditions

Neutropenia Agranulocytosis Body Temperature Changes Cancer Cytopenia Febrile Neutropenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cloxacillin and amikacin (once or twice daily dosage)

Drug

Primary outcomes

  1. Afebrile within 5 days of the initial treatment regimen

  2. Nephrotoxicity and ototoxicity

Secondary outcomes

  1. Cost difference

  2. Pharmacokinetic parameters of amikacin in these children

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Collaborators

  • National Research Council of Thailand

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Aug 12, 2005
Registry last updated
Sep 23, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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