Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129688
Status:
COMPLETED
Last Update Posted:
2005-09-23
First Post:
2005-08-10
Brief Title:
Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
Sponsor:
Khon Kaen University
Organization:
Khon Kaen University
Study Overview
Official Title:
Comparison of Efficacy Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children
Status:
COMPLETED
Status Verified Date:
2005-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Hypothesis Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic children in Khon Kaen Thailand
Detailed Description:
Fever a single oral temperature of 383 degrees C or 380 degrees C for 1 hour
Neutropenia neutrophil count 500cu mm or 1000cu mm with a predicted decrease to 500mm3
Neutropenia neutrophil count 500cu mm or 1000cu mm with a predicted decrease to 500mm3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 402545 | None | None | None |