Phase 3
N=252
Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)
Leukopenia
Bottom Line
View on ClinicalTrials.gov: NCT00811928 ↗Enrolled (actual)
252
Serious AEs
6.9%
Results posted
Sep 2011
Primary outcome: Primary: Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period — 4; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Posaconazole (Drug); Fluconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period |
4; 11 | — |
| SECONDARY Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization |
5; 16 | — |
| SECONDARY Time From Randomization to the First Onset of Proven or Probable IFI |
8; 2 | — |
| SECONDARY Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy |
4; 1 | — |
| SECONDARY Number of Participants With Clinical Failure During Treatment |
37; 51 | — |
| SECONDARY Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization |
3; 8 | — |
| SECONDARY Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization |
0; 0 | — |
Summary
A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection
Eligibility Criteria
Inclusion Criteria
- Participants must be 18-70 years of age of either sex
- Persistent neutropenia (Absolute Neutrophil Count [ANC] = 7 days caused by the following reasons
- Standard or dose-intense chemotherapy, anthracyclines or other acceptable chemotherapies ( any investigational drug is not permitted) for Acute Myelogenous Leukemia (AML) treatment
- Retreatment of chemotherapy in case of AML recurrence
- Myelodysplastic syndrome (MDS) shifts to AML and bone marrow arrest induction chemotherapy is required (not including acute phase of chronic myelogenous leukemia [CML])
- Informed consent obtained from participant or legal guardian
Exclusion Criteria
- Participants previously treated with amphotericin B (AMB), fluconazole (FLZ), or itraconazole (ITZ) within 30 days of enrollment.
- Participants who have taken the following drugs:
- terfenadine, cisapride, and ebastine within 24 hours before entry
- astemizole at entry or within 10 days before entry
- cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
- The above drugs are refrained during the investigation
- Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate 2× (Upper Limit of Normal) ULN.
- Participants having an electrocardiogram (ECG) with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
- Participants with AML or CML history.
- Participants with a history of allogeneic hematopoietic stem cell, bone marrow transplantation, autologous stem cell transplantation history.
- Female participants who are pregnant or are nursing.
- Alcohol and/or drug abuse.
- Participants cannot be compliant in the opinion of the investigator.
Data sourced from ClinicalTrials.gov (NCT00811928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.