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Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.

Publication ,  Journal Article
Gonzalez, D; Palazzi, DL; Bhattacharya-Mithal, L; Al-Uzri, A; James, LP; Bradley, J; Neu, N; Jasion, T; Hornik, CP; Smith, PB; Benjamin, DK ...
Published in: Antimicrob Agents Chemother
April 2016

We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum plasma concentration and area under the concentration versus time curve from 0 to 24 h were 0.74 μg/ml (0.61 μg/ml) and 9.28 μg · h/ml (6.30 μg · h/ml), respectively. The exposure and safety in this small cohort of adolescents were comparable to those for adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01966055.).

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Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

April 2016

Volume

60

Issue

4

Start / End Page

2572 / 2576

Location

United States

Related Subject Headings

  • Triazoles
  • Patient Safety
  • Microbiology
  • Male
  • Macrolides
  • Humans
  • Female
  • Dried Blood Spot Testing
  • Child
  • Bacterial Infections
 

Citation

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Gonzalez, D., Palazzi, D. L., Bhattacharya-Mithal, L., Al-Uzri, A., James, L. P., Bradley, J., … Cohen-Wolkowiez, M. (2016). Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents. Antimicrob Agents Chemother, 60(4), 2572–2576. https://doi.org/10.1128/AAC.02561-15
Gonzalez, Daniel, Debra L. Palazzi, Leena Bhattacharya-Mithal, Amira Al-Uzri, Laura P. James, John Bradley, Natalie Neu, et al. “Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.Antimicrob Agents Chemother 60, no. 4 (April 2016): 2572–76. https://doi.org/10.1128/AAC.02561-15.
Gonzalez D, Palazzi DL, Bhattacharya-Mithal L, Al-Uzri A, James LP, Bradley J, et al. Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents. Antimicrob Agents Chemother. 2016 Apr;60(4):2572–6.
Gonzalez, Daniel, et al. “Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.Antimicrob Agents Chemother, vol. 60, no. 4, Apr. 2016, pp. 2572–76. Pubmed, doi:10.1128/AAC.02561-15.
Gonzalez D, Palazzi DL, Bhattacharya-Mithal L, Al-Uzri A, James LP, Bradley J, Neu N, Jasion T, Hornik CP, Smith PB, Benjamin DK, Keedy K, Fernandes P, Cohen-Wolkowiez M. Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents. Antimicrob Agents Chemother. 2016 Apr;60(4):2572–2576.

Published In

Antimicrob Agents Chemother

DOI

EISSN

1098-6596

Publication Date

April 2016

Volume

60

Issue

4

Start / End Page

2572 / 2576

Location

United States

Related Subject Headings

  • Triazoles
  • Patient Safety
  • Microbiology
  • Male
  • Macrolides
  • Humans
  • Female
  • Dried Blood Spot Testing
  • Child
  • Bacterial Infections