Universität zu Köln

Duarte, Rafael F., Lopez-Jimenez, Javier, Cornely, Oliver A., Laverdiere, Michel, Helfgott, David, Haider, Shariq, Chandrasekar, Pranatharthi, Langston, Amelia, Perfect, John, Ma, Lei, van Iersel, Marlou L. P. S., Connelly, Nancy, Kartsonis, Nicholas and Waskin, Hetty (2014). Phase 1b Study of New Posaconazole Tablet for Prevention of Invasive Fungal Infections in High-Risk Patients with Neutropenia. Antimicrob. Agents Chemother., 58 (10). S. 5758 - 5766. WASHINGTON: AMER SOC MICROBIOLOGY. ISSN 1098-6596

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Abstract

Posaconazole tablets, a new oral formulation of posaconazole, can be effective when given as antifungal prophylaxis to neutropenic patients at high risk for invasive fungal infection (e. g., those with acute myelogenous leukemia or myelodysplastic syndrome). Such effectiveness might be specifically important to patients with poor oral intake because of nausea, vomiting, or chemotherapy-associated mucositis. This was a prospective, global study in high-risk patients to characterize the pharmacokinetics and safety profile of posaconazole tablets and to identify the dose of posaconazole tablets that would provide exposure within a predefined range of exposures (steady-state average concentration [area under the concentration-time curve/24 h] of >= 500 ng/ml and <= 2,500 ng/ml in > 90% of patients). The study evaluated two sequential dosing cohorts: 200 mg posaconazole once daily (n = 20) and 300 mg posaconazole once daily (n = 34) (both cohorts had a twice-daily loading dose on day 1) taken without regard to food intake during the neutropenic period for <= 28 days. The exposure target was reached (day 8) in 15 of 19 (79%) pharmacokinetic-evaluable patients taking 200 mg posaconazole once daily and in 31 of 32 (97%) patients taking 300 mg posaconazole once daily; 300 mg posaconazole once daily achieved the desired exposure target. Posaconazole tablets were generally well tolerated in high-risk neutropenic patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Duarte, Rafael F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lopez-Jimenez, Javier UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Laverdiere, Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Helfgott, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Haider, Shariq UNSPECIFIED UNSPECIFIED UNSPECIFIED Chandrasekar, Pranatharthi UNSPECIFIED UNSPECIFIED UNSPECIFIED Langston, Amelia UNSPECIFIED UNSPECIFIED UNSPECIFIED Perfect, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Ma, Lei UNSPECIFIED UNSPECIFIED UNSPECIFIED van Iersel, Marlou L. P. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Connelly, Nancy UNSPECIFIED UNSPECIFIED UNSPECIFIED Kartsonis, Nicholas UNSPECIFIED UNSPECIFIED UNSPECIFIED Waskin, Hetty UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-427829
DOI:	10.1128/AAC.03050-14
Journal or Publication Title:	Antimicrob. Agents Chemother.
Volume:	58
Number:	10
Page Range:	S. 5758 - 5766
Date:	2014
Publisher:	AMER SOC MICROBIOLOGY
Place of Publication:	WASHINGTON
ISSN:	1098-6596
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language VERSUS-HOST-DISEASE; EXPOSURE-RESPONSE RELATIONSHIP; ORAL POSACONAZOLE; HEALTHY-VOLUNTEERS; CANCER-PATIENTS; PHARMACOKINETICS; PROPHYLAXIS; CHEMOTHERAPY; FORMULATIONS; FLUCONAZOLE Multiple languages Microbiology; Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/42782