NeutropeniaNCT00129688
Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
A study testing cloxacillin and amikacin (once or twice daily dosage) in people with Neutropenia and Cancer, run by Khon Kaen University.
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. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Neutropenia, Cancer, Fever
- What is being tested?
- cloxacillin and amikacin (once or twice daily dosage)
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Received aminoglycoside within 14 days prior to enrolment
- Received any intravenous antibiotics within 7 days
- Cancer which is newly diagnosed or relapsed
About this study
Official title: 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.
Read the 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.
- Conditions
- Neutropenia, Cancer, Fever
- Being tested
- cloxacillin and amikacin (once or twice daily dosage)
- Keywords
- febrile neutropenia, once-daily, amikacin, cloxacillin, children
- Medical subject headings
- Neutropenia, Neoplasms, Fever, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cloxacillin and amikacin (once or twice daily dosage)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Afebrile within 5 days of the initial treatment regimen
Nephrotoxicity and ototoxicity
Secondary outcomes (2)
Cost difference
Pharmacokinetic parameters of amikacin in these children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startApr 2002
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Investigators
- Pope - Kosalaraksa, M.D., Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129688
- Sponsor's protocol ID
- HE44290
- Other IDs
- 40/2545
- Status last verified
- Feb 2005
- First submitted
- 10 Aug 2005
- Last updated
- 23 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children
- ClinicalTrials.gov ID
- NCT00129688
- Acronym / sponsor ID
- HE44290
- Conditions
- Neutropenia, Cancer, Fever
- Keywords
- febrile neutropenia, once-daily, amikacin, cloxacillin, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- Apr 2002
- Study completion
- Jun 2004
- First posted
- 12 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cloxacillin and amikacin (once or twice daily dosage) | Drug | – |
Primary outcome
Afebrile within 5 days of the initial treatment regimen
Nephrotoxicity and ototoxicity
2 secondary outcomes
Cost difference
Pharmacokinetic parameters of amikacin in these children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pope - Kosalaraksa, M.D. principal investigator
Khon Kaen University
Questions about this trial
What is this clinical trial studying?
A study testing cloxacillin and amikacin (once or twice daily dosage) in people with Neutropenia and Cancer, run by Khon Kaen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Afebrile within 5 days of the initial treatment regimen. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2005.