Pharmacokinetics and Pharmacodynamics of Linezolid in Children With Cystic Fibrosis
Alternative antimicrobial regimens are needed for treatment of methicillin‐resistant Staphylococcus aureus (MRSA)‐associated pulmonary exacerbations in children with cystic fibrosis (CF). There are no published pharmacokinetic (PK) and pharmacodynamic (PD) data for linezolid in children with CF. Obj...
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Published in | Pediatric pulmonology Vol. 44; no. 2; pp. 148 - 154 |
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Main Authors | , , , , , , , , , , |
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Language | English |
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Abstract | Alternative antimicrobial regimens are needed for treatment of methicillin‐resistant Staphylococcus aureus (MRSA)‐associated pulmonary exacerbations in children with cystic fibrosis (CF). There are no published pharmacokinetic (PK) and pharmacodynamic (PD) data for linezolid in children with CF.
Objectives
(1) To determine the PK and PD profile of linezolid among children with CF; (2) to characterize the effect of linezolid on MRSA infection; (3) to determine the effect of age and CF transmembrane regulator (CFTR) gene mutations on drug clearance.
Hypotheses
Linezolid clearance is enhanced in children with CF requiring a higher dosage regimen. Age and CFTR gene mutations affect drug clearance.
Methods
This was a retrospective cohort study; medical records of children with MRSA‐associated pulmonary exacerbations treated with linezolid (10 mg/kg/dose IV every 8h) were reviewed. Linezolid peak and trough concentrations in serum were determined by high performance liquid chromatography, PK profiles determined using standard noncompartmental method, and PD indices were evaluated.
Results
10 children (mean ± SD, 10.2 ± 5.5 years) received 14 courses of linezolid at 10 ± 0.4 mg/kg/dose every 8h for 15.4 ± 3.2 days. Seven had homozygous ΔF508 CFTR mutation. Peak and trough linezolid concentrations varied widely (range, 8.4–20.5 and 0.1–11.5 mcg/mL respectively). The PK profile of children <10 years differed significantly from older patients (≥10 years). The PK indices of children with homozygous ΔF508 differed marginally from those with heterozygous CFTR mutations, but there were too few subjects to allow separation of age and CFTR mutations effect. No patient achieved the target PD ratio of AUC/MIC >80. MRSA persisted in sputum or throat culture after treatment with linezolid.
Conclusions
Additional PK and PD data are needed to optimize linezolid therapy in children with cystic fibrosis; it is likely that higher doses will be needed. Pediatr Pulmonol. 2009; 44:148–154. © 2009 Wiley‐Liss, Inc. |
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AbstractList | Alternative antimicrobial regimens are needed for treatment of methicillin-resistant Staphylococcus aureus (MRSA)-associated pulmonary exacerbations in children with cystic fibrosis (CF). There are no published pharmacokinetic (PK) and pharmacodynamic (PD) data for linezolid in children with CF.
(1) To determine the PK and PD profile of linezolid among children with CF; (2) to characterize the effect of linezolid on MRSA infection; (3) to determine the effect of age and CF transmembrane regulator (CFTR) gene mutations on drug clearance.
Linezolid clearance is enhanced in children with CF requiring a higher dosage regimen. Age and CFTR gene mutations affect drug clearance.
This was a retrospective cohort study; medical records of children with MRSA-associated pulmonary exacerbations treated with linezolid (10 mg/kg/dose IV every 8h) were reviewed. Linezolid peak and trough concentrations in serum were determined by high performance liquid chromatography, PK profiles determined using standard noncompartmental method, and PD indices were evaluated.
10 children (mean +/- SD, 10.2 +/- 5.5 years) received 14 courses of linezolid at 10 +/- 0.4 mg/kg/dose every 8h for 15.4 +/- 3.2 days. Seven had homozygous DeltaF508 CFTR mutation. Peak and trough linezolid concentrations varied widely (range, 8.4-20.5 and 0.1-11.5 mcg/mL respectively). The PK profile of children <10 years differed significantly from older patients (>or=10 years). The PK indices of children with homozygous DeltaF508 differed marginally from those with heterozygous CFTR mutations, but there were too few subjects to allow separation of age and CFTR mutations effect. No patient achieved the target PD ratio of AUC/MIC >80. MRSA persisted in sputum or throat culture after treatment with linezolid.
Additional PK and PD data are needed to optimize linezolid therapy in children with cystic fibrosis; it is likely that higher doses will be needed. Abstract Alternative antimicrobial regimens are needed for treatment of methicillin‐resistant Staphylococcus aureus (MRSA)‐associated pulmonary exacerbations in children with cystic fibrosis (CF). There are no published pharmacokinetic (PK) and pharmacodynamic (PD) data for linezolid in children with CF. Objectives (1) To determine the PK and PD profile of linezolid among children with CF; (2) to characterize the effect of linezolid on MRSA infection; (3) to determine the effect of age and CF transmembrane regulator (CFTR) gene mutations on drug clearance. Hypotheses Linezolid clearance is enhanced in children with CF requiring a higher dosage regimen. Age and CFTR gene mutations affect drug clearance. Methods This was a retrospective cohort study; medical records of children with MRSA‐associated pulmonary exacerbations treated with linezolid (10 mg/kg/dose IV every 8h) were reviewed. Linezolid peak and trough concentrations in serum were determined by high performance liquid chromatography, PK profiles determined using standard noncompartmental method, and PD indices were evaluated. Results 10 children (mean ± SD, 10.2 ± 5.5 years) received 14 courses of linezolid at 10 ± 0.4 mg/kg/dose every 8h for 15.4 ± 3.2 days. Seven had homozygous ΔF508 CFTR mutation. Peak and trough linezolid concentrations varied widely (range, 8.4–20.5 and 0.1–11.5 mcg/mL respectively). The PK profile of children <10 years differed significantly from older patients (≥10 years). The PK indices of children with homozygous ΔF508 differed marginally from those with heterozygous CFTR mutations, but there were too few subjects to allow separation of age and CFTR mutations effect. No patient achieved the target PD ratio of AUC/MIC >80. MRSA persisted in sputum or throat culture after treatment with linezolid. Conclusions Additional PK and PD data are needed to optimize linezolid therapy in children with cystic fibrosis; it is likely that higher doses will be needed. Pediatr Pulmonol. 2009; 44:148–154. © 2009 Wiley‐Liss, Inc. Alternative antimicrobial regimens are needed for treatment of methicillin‐resistant Staphylococcus aureus (MRSA)‐associated pulmonary exacerbations in children with cystic fibrosis (CF). There are no published pharmacokinetic (PK) and pharmacodynamic (PD) data for linezolid in children with CF. Objectives (1) To determine the PK and PD profile of linezolid among children with CF; (2) to characterize the effect of linezolid on MRSA infection; (3) to determine the effect of age and CF transmembrane regulator (CFTR) gene mutations on drug clearance. Hypotheses Linezolid clearance is enhanced in children with CF requiring a higher dosage regimen. Age and CFTR gene mutations affect drug clearance. Methods This was a retrospective cohort study; medical records of children with MRSA‐associated pulmonary exacerbations treated with linezolid (10 mg/kg/dose IV every 8h) were reviewed. Linezolid peak and trough concentrations in serum were determined by high performance liquid chromatography, PK profiles determined using standard noncompartmental method, and PD indices were evaluated. Results 10 children (mean ± SD, 10.2 ± 5.5 years) received 14 courses of linezolid at 10 ± 0.4 mg/kg/dose every 8h for 15.4 ± 3.2 days. Seven had homozygous ΔF508 CFTR mutation. Peak and trough linezolid concentrations varied widely (range, 8.4–20.5 and 0.1–11.5 mcg/mL respectively). The PK profile of children <10 years differed significantly from older patients (≥10 years). The PK indices of children with homozygous ΔF508 differed marginally from those with heterozygous CFTR mutations, but there were too few subjects to allow separation of age and CFTR mutations effect. No patient achieved the target PD ratio of AUC/MIC >80. MRSA persisted in sputum or throat culture after treatment with linezolid. Conclusions Additional PK and PD data are needed to optimize linezolid therapy in children with cystic fibrosis; it is likely that higher doses will be needed. Pediatr Pulmonol. 2009; 44:148–154. © 2009 Wiley‐Liss, Inc. UNLABELLEDAlternative antimicrobial regimens are needed for treatment of methicillin-resistant Staphylococcus aureus (MRSA)-associated pulmonary exacerbations in children with cystic fibrosis (CF). There are no published pharmacokinetic (PK) and pharmacodynamic (PD) data for linezolid in children with CF.OBJECTIVES(1) To determine the PK and PD profile of linezolid among children with CF; (2) to characterize the effect of linezolid on MRSA infection; (3) to determine the effect of age and CF transmembrane regulator (CFTR) gene mutations on drug clearance.HYPOTHESESLinezolid clearance is enhanced in children with CF requiring a higher dosage regimen. Age and CFTR gene mutations affect drug clearance.METHODSThis was a retrospective cohort study; medical records of children with MRSA-associated pulmonary exacerbations treated with linezolid (10 mg/kg/dose IV every 8h) were reviewed. Linezolid peak and trough concentrations in serum were determined by high performance liquid chromatography, PK profiles determined using standard noncompartmental method, and PD indices were evaluated.RESULTS10 children (mean +/- SD, 10.2 +/- 5.5 years) received 14 courses of linezolid at 10 +/- 0.4 mg/kg/dose every 8h for 15.4 +/- 3.2 days. Seven had homozygous DeltaF508 CFTR mutation. Peak and trough linezolid concentrations varied widely (range, 8.4-20.5 and 0.1-11.5 mcg/mL respectively). The PK profile of children <10 years differed significantly from older patients (>or=10 years). The PK indices of children with homozygous DeltaF508 differed marginally from those with heterozygous CFTR mutations, but there were too few subjects to allow separation of age and CFTR mutations effect. No patient achieved the target PD ratio of AUC/MIC >80. MRSA persisted in sputum or throat culture after treatment with linezolid.CONCLUSIONSAdditional PK and PD data are needed to optimize linezolid therapy in children with cystic fibrosis; it is likely that higher doses will be needed. |
Author | Prestidge, Claude B. Urbancyzk, Brenda Sanchez, Pablo J. Jafri, Hasan S. Murphey, Donald K. McCracken Jr, George H. Santos, Roberto P. Ahmad, Naveed Siegel, Jane D. Brown, Michael E. Salvatore, Christine M. |
Author_xml | – sequence: 1 givenname: Roberto P. surname: Santos fullname: Santos, Roberto P. email: santosr@mail.amc.edu organization: Division of Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center Dallas, Dallas, Texas – sequence: 2 givenname: Claude B. surname: Prestidge fullname: Prestidge, Claude B. organization: Cystic Fibrosis Care and Teaching Center, Children's Medical Center Dallas, Dallas, Texas – sequence: 3 givenname: Michael E. surname: Brown fullname: Brown, Michael E. organization: Cystic Fibrosis Care and Teaching Center, Children's Medical Center Dallas, Dallas, Texas – sequence: 4 givenname: Brenda surname: Urbancyzk fullname: Urbancyzk, Brenda organization: Cystic Fibrosis Care and Teaching Center, Children's Medical Center Dallas, Dallas, Texas – sequence: 5 givenname: Donald K. surname: Murphey fullname: Murphey, Donald K. organization: Cook Children's Medical Center, Fort Worth, Texas – sequence: 6 givenname: Christine M. surname: Salvatore fullname: Salvatore, Christine M. organization: Division of Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center Dallas, Dallas, Texas – sequence: 7 givenname: Hasan S. surname: Jafri fullname: Jafri, Hasan S. organization: Division of Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center Dallas, Dallas, Texas – sequence: 8 givenname: George H. surname: McCracken Jr fullname: McCracken Jr, George H. organization: Division of Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center Dallas, Dallas, Texas – sequence: 9 givenname: Naveed surname: Ahmad fullname: Ahmad, Naveed organization: Research Department, Children's Medical Center Dallas, Dallas, Texas – sequence: 10 givenname: Pablo J. surname: Sanchez fullname: Sanchez, Pablo J. organization: Division of Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center Dallas, Dallas, Texas – sequence: 11 givenname: Jane D. surname: Siegel fullname: Siegel, Jane D. organization: Division of Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center Dallas, Dallas, Texas |
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Keywords | Human Linezolid Pediatrics Typing Respiratory disease pharmacodynamics Metabolic diseases Genotype Cystic fibrosis Biological activity Genetic disease Phenotype Microbiological investigation Bacteria Micrococcales Digestive diseases Micrococcaceae Antibacterial agent Pharmacokinetics Child Staphylococcus aureus Pancreatic disease Pneumology |
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Snippet | Alternative antimicrobial regimens are needed for treatment of methicillin‐resistant Staphylococcus aureus (MRSA)‐associated pulmonary exacerbations in... Alternative antimicrobial regimens are needed for treatment of methicillin-resistant Staphylococcus aureus (MRSA)-associated pulmonary exacerbations in... Abstract Alternative antimicrobial regimens are needed for treatment of methicillin‐resistant Staphylococcus aureus (MRSA)‐associated pulmonary exacerbations... UNLABELLEDAlternative antimicrobial regimens are needed for treatment of methicillin-resistant Staphylococcus aureus (MRSA)-associated pulmonary exacerbations... |
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SubjectTerms | Acetamides - administration & dosage Acetamides - pharmacokinetics Acetamides - therapeutic use Adolescent Anti-Infective Agents - administration & dosage Anti-Infective Agents - pharmacokinetics Anti-Infective Agents - therapeutic use Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Biological and medical sciences Child Child, Preschool Cystic Fibrosis - drug therapy Cystic Fibrosis Transmembrane Conductance Regulator Errors of metabolism Female General aspects genotype Humans Linezolid Male Medical sciences Metabolic diseases Methicillin-Resistant Staphylococcus aureus - drug effects Miscellaneous hereditary metabolic disorders Oxazolidinones - administration & dosage Oxazolidinones - pharmacokinetics Oxazolidinones - therapeutic use pharmacodynamics pharmacokinetics Pharmacology. Drug treatments phenotype Pneumology Retrospective Studies Staphylococcus aureus |
Title | Pharmacokinetics and Pharmacodynamics of Linezolid in Children With Cystic Fibrosis |
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