1. Increased Doses Lead to Higher Drug Exposures of Levofloxacin for Treatment of Tuberculosis
- Author
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Kathleen D. Eisenach, Eduardo Gotuzzo, Pawandeep Kaur, Nancy Dianis, Bruno Martel, Carlos Seas, Andreas H. Diacon, Florian von Groote-Bidlingmaier, Leonid Lecca, Patrick P. J. Phillips, R. F. Patientia, Charles A. Peloquin, Carole D. Mitnick, Dante Vargas, C. Robert Horsburgh, Antonio Moreno-Martinez, Kathleen Robergeau Hunt, Juan Santillan, Neel R. Gandhi, and Donna Butler
- Subjects
Male ,0301 basic medicine ,Antitubercular Agents ,Levofloxacin ,Pharmacology ,0302 clinical medicine ,Tuberculosis, Multidrug-Resistant ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Lead (electronics) ,media_common ,Pharmacology and Pharmaceutical Sciences ,Multidrug-Resistant ,Middle Aged ,Infectious Diseases ,tuberculosis ,Medical Microbiology ,Area Under Curve ,Plasma concentration ,HIV/AIDS ,Female ,Infection ,pharmacokinetics ,medicine.drug ,Adult ,Drug ,Tuberculosis ,Adolescent ,media_common.quotation_subject ,Clinical Trials and Supportive Activities ,030106 microbiology ,Cmax ,purl.org/pe-repo/ocde/ford#3.03.08 [https] ,Microbiology ,Young Adult ,03 medical and health sciences ,Rare Diseases ,Pharmacokinetics ,Clinical Research ,Humans ,purl.org/pe-repo/ocde/ford#3.01.05 [https] ,Aged ,levofloxacin ,business.industry ,Mycobacterium tuberculosis ,medicine.disease ,Good Health and Well Being ,business ,antitubercular agents - Abstract
Patients with multidrug-resistant tuberculosis in Peru and South Africa were randomized to a weight-banded nominal dose of 11, 14, 17, or 20 mg/kg/day levofloxacin (minimum, 750 mg) in combination with other second-line agents. A total of 101 patients were included in noncompartmental pharmacokinetic analyses. Respective median areas under the concentration-time curve from 0 to 24 h (AUC(0−24)) were 109.49, 97.86, 145.33, and 207.04 μg · h/ml. Median maximum plasma concentration (C(max)) were 11.90, 12.02, 14.86, and 19.17 μg/ml, respectively. Higher levofloxacin doses, up to 1,500 mg daily, resulted in higher exposures. (This study has been registered at ClinicalTrials.gov under identifier NCT01918397.)
- Published
- 2018