NCT01344681 is a Phase 2 clinical trial of Micafungin sodium in Febrile Neutropenia, sponsored by Yonsei University.

Who is sponsoring NCT01344681?

NCT01344681 is sponsored by Yonsei University.

What drugs are being tested in NCT01344681?

Interventions in NCT01344681: Micafungin sodium, Itraconazole.

What condition does NCT01344681 study?

NCT01344681 studies Febrile Neutropenia, Hematological Diseases.

Is NCT01344681 still recruiting?

NCT01344681 is currently completed. Last updated 4 December 2014.

Last reviewed 2014-12-04 · How we verify

NCT01344681

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 4 December 2014

What this trial tests

Phase 2 trial testing Micafungin sodium in Febrile Neutropenia in 153 participants. Completed in 1 March 2014.

Timeline

1 June 2011

Primary endpoint
1 March 2014

1 March 2014

Quick facts

Lead sponsor	Yonsei University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	153
Start date	1 June 2011
Primary completion	1 March 2014
Estimated completion	1 March 2014
Sites	7 locations across South Korea

Drugs / interventions tested

Micafungin sodium — full drug profile →
Itraconazole — full drug profile →

Conditions studied

Febrile Neutropenia — all drugs for Febrile Neutropenia →
Hematological Diseases — all drugs for Hematological Diseases →

Sponsor

Yonsei University

Who can join

Adults 18 to 65, any sex, with Febrile Neutropenia or Hematological Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and safety of micafungin versus intravenous itraconazole as empirical antifungal therapy for febrile neutropenic patients with hematological malignancies: a randomized, controlled, prospective, multicenter study.
Jeong SH, Kim DY, Jang JH, Mun YC, et al · · 2016 · cited 17× · PMID 26596974 · DOI 10.1007/s00277-015-2545-2

Verify or expand the search:

Other recruiting trials for Febrile Neutropenia

Currently open trials in the same condition.

NCT07204522 — Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients. · recruiting
NCT05815628 — Next-Generation-Sequencing Approach to Neutropenic Sepsis · recruiting
NCT06787326 — Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With F · active not recruiting
NCT05786495 — Short Antibiotic Treatment in High Risk Febrile Neutropenia · NA · recruiting

Other Yonsei University trials

Trials by the same sponsor.

NCT07547592 — Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma · Phase 2 · not yet recruiting
NCT07524101 — Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD · NA · not yet recruiting
NCT07506629 — Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty · NA · not yet recruiting
NCT07515716 — Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia · NA · not yet recruiting
NCT07507188 — Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01344681 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yonsei University
Last refreshed: 4 December 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01344681.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing