JOURNAL ARTICLE
REVIEW

Clinical efficacy and tolerability of linezolid in pediatric patients: a systematic review

Elena Chiappini, Camilla Conti, Luisa Galli, Maurizio de Martino
Clinical Therapeutics 2010, 32 (1): 66-88
20171414

BACKGROUND: Linezolid is marketed for the treatment of severe, vancomycin-resistant infections with gram-positive bacteria in adults. Most information regarding the pharmacokinetic profile, efficacy, and tolerability of linezolid is derived from adult studies.

OBJECTIVE: The aim of this review was to summarize evidence regarding the use of linezolid in infants and children, focusing on the drug's clinical efficacy data and tolerability profile.

METHODS: A literature search was conducted of the Cochrane Library, EMBASE, and MEDLINE databases, from their inception through July 20, 2009, using the following terms: linezolid, newborn, infant, child, pediatrics, adolescent, human, clinical trial, and case report. Articles were excluded if they were redundant or not pertinent. (Articles that did not focus on the use of linezolid in children were considered not pertinent.) Bibliographies of all relevant articles were also evaluated.

RESULTS: Forty-seven publications regarding the use of linezolid in children were included in the review: 5 pharmacokinetic studies, 32 case reports, 6 randomized clinical trials (RCTs), 2 uncontrolled trials, 1 subanalysis of 2 published RCTs, and 1 subanalysis of published data about linezolid's tolerability. Pharmacokinetic data on linezolid use in children were derived from studies that enrolled 447 children. Plasma pharmacokinetics of linezolid in pediatric patients were found to be age dependent. Results from 6 vancomycinor cefadroxil-controlled RCTs (including 1480 children) evaluating linezolid treatment in children reported variable clinical cure rates, ranging from 75.0% to 93.2% in children with skin and skin-structure infections and from 77.5% to 90.0% in children with bacteremia or pneumonia. No significant difference in clinical cure rates between the linezolid group and the comparator group was observed in any study. The most frequently reported adverse events were diarrhea (from 3.1% to 16.8%), nausea and/or vomiting (from 2.9% to 11.9%), and thrombocytopenia (from 1.9% to 4.7%). To date, 3 cases of neuropathy have been described in children.

CONCLUSIONS: The reviewed pediatric studies in skin and skin-structure infections, bacteremia, or pneumonia found that linezolid was associated with high clinical cure rates (75.0%-93.2%) that did not differ significantly from those of vancomycin or cefadroxil. RCTs enrolling children with other types of infection (eg, osteomyelitis, endocarditis), as well as long-term studies, are needed to draw definitive conclusions about linezolid's efficacy and tolerability in pediatric patients. Careful monitoring for adverse events and possible linezolid resistance continues to be essential.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
20171414
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"

We want to hear from doctors like you!

Take a second to answer a survey question.