Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)

Phase 3 Completed 602 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelPrevention

Summary

This trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections. Profound, prolonged neutropenia (Absolute neutrophil count\<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome. Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review.

Timeline

Start: 2002-07
Primary completion: 2004-12
Completion: 2005-04

Outcome

Met primary endpoint

paper Proven or probable invasive fungal infections were reported in 7 patients (2%) in the posaconazole group and 25 patients (8%) PMID 17251531 ↗

paper 95% confidence interval, -9.7 to -2.5%; P<0.001), fulfilling statistical criteria for superiority. PMID 17251531 ↗

Publications

Cornely OA, Maertens J, Winston DJ, Perfect J, Ullmann AJ, Walsh TJ, Helfgott D, Holowiecki J, Stockelberg D, Goh YT, Petrini M, Hardalo C, Suresh R, Angulo-Gonzalez D. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N Engl J Med. 2007 Jan 25;356(4):348-59. doi: 10.1056/NEJMoa061094.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Posaconazole	Small molecule	—	Oral