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Antimicrobial Agents and Chemotherapy, March 2007, p. 812-818, Vol. 51, No. 3
0066-4804/07/$08.00+0     doi:10.1128/AAC.00454-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Posaconazole Plasma Concentrations in Juvenile Patients with Invasive Fungal Infection{triangledown}

Gopal Krishna,* Angela Sansone-Parsons, Monika Martinho, Bhavna Kantesaria, and Lisa Pedicone

Schering-Plough Research Institute, Kenilworth, New Jersey

Received 11 April 2006/ Returned for modification 10 June 2006/ Accepted 22 December 2006

Posaconazole is an orally bioavailable triazole antifungal agent for the treatment and prophylaxis of invasive fungal infection. We evaluated plasma posaconazole concentration data from juvenile (younger than 18 years; n = 12) and adult (18 to 64 years; n = 194) patients who participated in a multicenter, phase 3, open-label study that assessed the efficacy and safety of posaconazole treatment for persons who were intolerant of or had invasive fungal infection refractory to standard antifungal therapies. With the exception of one juvenile patient who received 400 mg/day as a divided dose on the day of sample collection, all patients received posaconazole at 800 mg/day as an oral suspension in divided doses. Plasma samples were analyzed through a validated liquid chromatographic-tandem mass spectrometric method with a lower limit of quantitation of 1 ng/ml. Because plasma posaconazole concentrations are relatively constant at steady state, the average of all plasma concentrations (Cav) for each patient was calculated to provide a single steady-state plasma posaconazole concentration. A blinded data review committee reviewed all treatment outcomes. Variable posaconazole plasma concentrations were observed within both the juvenile and adult populations. Mean (median [range]) Cav values for juvenile and adult patients were 776 ng/ml (579 ng/ml [85.3 to 2,891 ng/ml]) and 817 ng/ml (626 ng/ml [0 to 3,710 ng/ml]), respectively. Overall success rates and adverse event profiles were comparable. In conclusion, posaconazole concentrations in plasma were similar for juvenile and adult patients, suggesting that clinical outcomes are expected to be similar in adults and children with refractory invasive fungal infection.

* Corresponding author. Mailing address: Schering-Plough Research Institute, K-15-2, 2650 Galloping Hill Road, Kenilworth, New Jersey 07033. Phone: (908) 740 6564. Fax: (908) 740 2916. E-mail: gopal.krishna{at}spcorp.com.

{triangledown} Published ahead of print on 8 January 2007.

Antimicrobial Agents and Chemotherapy, March 2007, p. 812-818, Vol. 51, No. 3
0066-4804/07/$08.00+0     doi:10.1128/AAC.00454-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Krishna, G., Moton, A., Ma, L., Medlock, M. M., McLeod, J. (2009). Pharmacokinetics and Absorption of Posaconazole Oral Suspension under Various Gastric Conditions in Healthy Volunteers. Antimicrob. Agents Chemother. 53: 958-966 [Abstract] [Full Text]  
  • Morris, M. I. (2009). Posaconazole: A new oral antifungal agent with an expanded spectrum of activity. Am J Health Syst Pharm 66: 225-236 [Abstract] [Full Text]  
  • Andes, D., Pascual, A., Marchetti, O. (2009). Antifungal Therapeutic Drug Monitoring: Established and Emerging Indications. Antimicrob. Agents Chemother. 53: 24-34 [Full Text]  


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