A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-05-02

Brief Summary

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The purpose of this study is to investigate the hypothesis that the efficacy of intravenous (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous caspofungin as empiric therapy for suspected fungal infection participants with fever and neutropenia.

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Detailed Description

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Conditions

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Hematologic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Itraconazole

Group Type EXPERIMENTAL

Itraconazole

Intervention Type DRUG

Participants will receive 200 milligram (mg) of itraconazole intravenously (IV) twice daily on Day 1 and Day 2, followed by 200 mg once daily through Day 14. From Day 15 to Day 28, participants will receive 200 mg (20 milliliters \[mL\]) of itraconazole oral solution orally twice daily. Participants, who are not suitable for oral administration of itraconazole based on the investigator's judgment, will receive 200 mg of itaconazole IV once daily from Day 15 to Day 28.

Caspofungin

Group Type ACTIVE_COMPARATOR

Caspofungin

Intervention Type DRUG

Participants will receive 70 mg of caspofungin IV once daily on Day 1 followed by 50 mg IV infusion once daily thereafter through Day 28.

Interventions

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Itraconazole

Participants will receive 200 milligram (mg) of itraconazole intravenously (IV) twice daily on Day 1 and Day 2, followed by 200 mg once daily through Day 14. From Day 15 to Day 28, participants will receive 200 mg (20 milliliters \[mL\]) of itraconazole oral solution orally twice daily. Participants, who are not suitable for oral administration of itraconazole based on the investigator's judgment, will receive 200 mg of itaconazole IV once daily from Day 15 to Day 28.

Intervention Type DRUG

Caspofungin

Participants will receive 70 mg of caspofungin IV once daily on Day 1 followed by 50 mg IV infusion once daily thereafter through Day 28.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant must be hospitalized with hematologic malignancy treated by myelosuppressive therapy and/or Hematopoietic stem cell transplantation
* Participant must have a diagnosis of neutropenia with neutrophil count \< 500/microliters (mcL) (0.5 × 10\^9/ liters \[L\]) for at least 96 hours at screening
* Participant must have a diagnosis of fever and meet the following criteria: 1) Oral/rectal temperature greater than or equal to (\>=) 38 degree celsius or axillary temperature (\>=) 37.5 degree celsius and is not considered related to blood products transfusion or drug fever, 2) Not responding to broad-spectrum gram-positive and gram-negative antibiotics for 4-7 days with or without signs and symptoms that potentially attributable to deep fungal infection and 3) Defervescence within 3 days after the first broad-spectrum antibiotics but recurrence afterwards.
* A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[b hCG\]) and pregnancy test at screening
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study period and until the menstrual period following the end of study treatment

Exclusion Criteria

* Is concomitantly using other systematic antifungal drugs as empirical treatment
* Has evidence of inadequately managed bacterial infection
* Is currently receiving any Cytochrome P450 3A4 (CYP3A4)-metabolized/P-glycoprotein-transported drugs (including but not limited to cisapride, pimozide, quinidine, dofetilide, levacetylmethadol, terfenadine, astemizole, mizolastine, bepridil, sertindole, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG-CoA reductase) inhibitor \[for example, simvastatin, lovastatin\], oral midazolam, triazolam, ergot alkaloids \[eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine\] and nisoldipine) that should be prohibited in this study
* Has known allergy, intolerance or hypersensitivity to azole and echinocandin antifungals or its excipients
* Has a contraindication to the use of sodium chloride injection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No