Clinical trial NCT02895529: A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy
Official title: A Multicenter, Randomized Trial Comparing The Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Subjects With Hematological Malignancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hematologic Neoplasms
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints
timeFrame: Up to 36 days
Secondary outcomes:
measure: Percentage of Participants With Survival for 7 Days After Completion of Treatment
timeFrame: Up to 36 days
measure: Percentage of Participants With Absence of Breakthrough Invasive Fungal Infection
timeFrame: Day 3 up to Day 28 (End of treatment [EoT]) and within 7 days after EoT (Day 29 up to Day 35)
measure: Percentage of Participants With Successful Treatment of Baseline Fungal Infection
timeFrame: Screening up to Day 3
measure: Percentage of Participants With Defervescence During the Period of Neutropenia
timeFrame: Up to 36 days
measure: Percentage of Participants With No Premature Withdrawal From the Study due to Drug-related Toxicity or Lack of Efficacy
timeFrame: Up to 36 days
measure: Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints With Oral Administration of Itraconazole
timeFrame: Up to 36 days
Other outcomes:
Locations:
city: Beijign
country: China
city: Beijing
country: China
city: Changchun
country: China
city: Changzhou
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Guiyang
country: China
city: Hefei
country: China
city: Shanghai
country: China
city: Suzhou
country: China
city: Tianjin
country: China
city: Zhengzhou
country: China
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: