NCT01344681

Brief 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, randomized, non-inferiority trials. Therefore, this study was planned for review of the safety and efficacy in korean patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

April 25, 2011

Last Update Submit

December 4, 2014

Conditions

Febrile NeutropeniaHematological Diseases

Outcome Measures

Primary Outcomes (1)

  • Responses to therapy

    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'

    7 days after stopping study medication

Study Arms (2)

Arm A

EXPERIMENTAL

Micafungin sodium

Drug: Micafungin sodium

Arm B

ACTIVE COMPARATOR

Itraconazole

Drug: Itraconazole

Interventions

Micafungin sodiumDRUG

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.

Also known as: Mycamine®
Arm A
ItraconazoleDRUG

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.

Also known as: Sporanox®
Arm B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Dong-A Medical Center

Busan, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

ASAN Medical Center

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Ajou University Medical Center

Suwon, South Korea

Location

MeSH Terms

Conditions

Febrile NeutropeniaHematologic Diseases

Interventions

MicafunginItraconazole

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, CyclicTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 29, 2011

Study Start

June 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

KR(7)