Febrile NeutropeniaPhase 2NCT01344681
Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases
A Phase 2 study testing Micafungin sodium and Itraconazole in people with Febrile Neutropenia and Hematological Diseases, run by Yonsei University at 7 sites in South Korea.
Trial summary
This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Febrile Neutropenia, Hematological Diseases
- What is being tested?
- Micafungin sodium and Itraconazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Jun 2011to Mar 2014
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The male and female patients over 18 years
- To participate in clinical trials and voluntary written consent requirement to comply with a patient
- Chemotherapy with a variety of hematologic malignancies or patients undergoing stem cell transplantation
- Fever (temperature ≥ 38.4 ℃) showing Neutropenia (absolute neutrophil count <500/mm3) patients
- Combined antibiotic therapy 72 hours after the expiration of term lasts three patients
Who cannot join
- Of clinical trials of breast-feeding or pregnant women of childbearing age with intent to
- Adapted species (candida genus, aspergillus genus) Colitis caused by fungi other than the patients with fungal infection
- HIV-positive patient serum
- This test within 30 days of assignment to the other patients participating in clinical trials
- Within 72 hours of registration before the patients treated with systemic antifungal agents
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Dong-A Medical Center
Busan
Severance Hospital
Seoul, 120-752
Korea University Guro Hospital
Seoul, 152-703
ASAN Medical Center
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Samsung Medical Center
Seoul
Ajou University Medical Center
Suwon
About this study
Official title: A Randomized Phase II, Multi-center, Non-inferiority Clinical Trial for Efficacy and Safety of Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases
This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials.
Therefore, this study was planned for review of the safety and efficacy in korean patients.
- Conditions
- Febrile Neutropenia, Hematological Diseases
- Being tested
- Micafungin sodium, Itraconazole
- Medical subject headings
- Febrile Neutropenia, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micafungin sodiumDrug
Also called Mycamine®
- Treatment period (active treatment): an average 14 days
- Dosage:
- Study Drug: Micafungin sodium (mycamine ® injections 50mg/vial) 2 vials (100mg / day)
- Administration Method:
- Study Drug: 3-5 days after fever begins. Infusion one time a day (one hour). Termination of treatment after maintaining fever for three days or the recovery of neutrophils with no fever.
ItraconazoleDrug
Also called Sporanox®
- Treatment period (active treatment): an average 14 days
- Dosage:
- Active Comparator: Itraconazole (Sporanox ® injection) 200 mg 2 times(400mg / day)
- Administration Method:
- Active Comparator: 200 mg two times(400 mg) a day, total of 4 times for 2 days and then one times (200 mg) a day for 12 days. Termination of treatment after keeping fever for three days or the recovery of neutrophils with no fever.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Micafungin sodium Receives: Drug: Micafungin sodium |
| Arm B | Active comparator | Itraconazole Receives: Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responses to therapy
- definition of 'treatment success': (5 Items to meet all your success)
- Within 7 days after stopping study medication if there is no fungal infection
- 7 days after stopping study medication if you are alive
- Neutropenia period of serious adverse events or lack of effective medication is not stopped
- If fever during neutropenia (temperature <37.5 ℃)
- Treatment until the end of the existing fungal infection is treated completely or partially
- definition of 'treatment failure': - If you failed any of 5 Items in 'treatment success'
Measured: 7 days after stopping study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344681
- Sponsor's protocol ID
- 4-2011-0794
- Status last verified
- Dec 2014
- First submitted
- 25 Apr 2011
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II, Multi-center, Non-inferiority Clinical Trial for Efficacy and Safety of Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases
- ClinicalTrials.gov ID
- NCT01344681
- Acronym / sponsor ID
- 4-2011-0794
- Conditions
- Febrile Neutropenia, Hematological Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Apr 2011 (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.
This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials.
Therefore, this study was planned for review of the safety and efficacy in korean patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Micafungin sodiumMicafungin sodium |
| Arm B | Active comparator | Drug: ItraconazoleItraconazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The male and female patients over 18 years
- To participate in clinical trials and voluntary written consent requirement to comply with a patient
- Chemotherapy with a variety of hematologic malignancies or patients undergoing stem cell transplantation
- Fever (temperature ≥ 38.4 ℃) showing Neutropenia (absolute neutrophil count <500/mm3) patients
- Combined antibiotic therapy 72 hours after the expiration of term lasts three patients
Key exclusion criteria (5 listed)
- Of clinical trials of breast-feeding or pregnant women of childbearing age with intent to
- Adapted species (candida genus, aspergillus genus) Colitis caused by fungi other than the patients with fungal infection
- HIV-positive patient serum
- This test within 30 days of assignment to the other patients participating in clinical trials
- Within 72 hours of registration before the patients treated with systemic antifungal agents
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 |
|---|---|---|
| Micafungin sodiumAlso: Mycamine®1. Treatment period (active treatment): an average 14 days 2. Dosage: - Study Drug: Micafungin sodium (mycamine ® injections 50mg/vial) 2 vials (100mg / day) 3. Administration Method: * Study Drug: 3-5 days after fever begins. Infusion one time a day (one hour). Termination of treatment after maintaining fever for three days or the recovery of neutrophils with no fever. | Drug | Arm A |
| ItraconazoleAlso: Sporanox®1. Treatment period (active treatment): an average 14 days 2. Dosage: - Active Comparator: Itraconazole (Sporanox ® injection) 200 mg 2 times(400mg / day) 3. Administration Method: * Active Comparator: 200 mg two times(400 mg) a day, total of 4 times for 2 days and then one times (200 mg) a day for 12 days. Termination of treatment after keeping fever for three days or the recovery of neutrophils with no fever. | Drug | Arm B |
Primary outcome
Responses to therapy
Time frame: 7 days after stopping study medication
1. definition of 'treatment success': (5 Items to meet all your success) * Within 7 days after stopping study medication if there is no fungal infection * 7 days after stopping study medication if you are alive * Neutropenia period of serious adverse events or lack of effective medication is not stopped * If fever during neutropenia (temperature <37.5 ℃) * Treatment until the end of the existing fungal infection is treated completely or partially 2. definition of 'treatment failure': - If you failed any of 5 Items in 'treatment success'
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 8 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micafungin sodium and Itraconazole in people with Febrile Neutropenia and Hematological Diseases, run by Yonsei University at 7 sites in South Korea.
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 5 inclusion and 5 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Responses to therapy (time frame: 7 days after stopping study medication). 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 8 Dec 2014.