PMID- 14520146
OWN - NLM
STAT- MEDLINE
DCOM- 20031112
LR  - 20151119
IS  - 0891-3668 (Print)
IS  - 0891-3668 (Linking)
VI  - 22
IP  - 9 Suppl
DP  - 2003 Sep
TI  - Safety and tolerability of linezolid in children.
PG  - S193-200
AB  - BACKGROUND: Linezolid, an oxazolidinone, is effective in the treatment of adults 
      and children with community-acquired and nosocomial pneumonia and uncomplicated 
      and complicated skin and skin structure infections (SSSIs), including infections 
      caused by Gram-positive resistant pathogens. Because of the increasing use of 
      linezolid, it is important to review the common adverse events (AEs) associated 
      with its use in children with the use of data from clinical trials. OBJECTIVE: 
      The safety and tolerability of linezolid in pediatric patients with Gram-positive 
      infections were determined in four pediatric clinical studies. Study I included 
      pediatric patients with community-acquired pneumonia; Study II included otitis 
      media; Study III included SSSIs; and Study IV included complicated SSSIs, 
      nosocomial pneumonia and bacteremia. METHODS: Studies I and II had no comparator 
      arm. Study III was randomized and compared linezolid with cefadroxil. Study IV 
      also was randomized and compared linezolid with vancomycin. Patients <12 years of 
      age received linezolid 10 mg/kg; patients age 12 years and older received 600 mg 
      (intravenous/oral). Dosing frequency (two to three times daily) varied depending 
      on age and clinical diagnosis. The primary safety endpoints were AEs, 
      drug-related AEs, serious AEs and selected laboratory tests. RESULTS: In the 4 
      studies 958 patients were included in the intent-to-treat analysis. In the 
      linezolid vs. cefadroxil study (Study III), the most common AEs in patients 
      treated with linezolid were diarrhea (7.8%), headache (6.5%) and upper 
      respiratory tract infection (3.7%). In the linezolid vs. vancomycin study (Study 
      IV), the most common AEs in the linezolid group were fever (14.1%), diarrhea 
      (10.8%) and vomiting (9.4%). The most common drug-related AEs for linezolid in 
      all 4 studies were diarrhea, vomiting, loose stools and nausea. None of these 
      common AEs or drug-related AEs occurred more frequently in patients treated with 
      linezolid than in those in the comparator group. CONCLUSIONS: Linezolid was safe 
      and well-tolerated in pediatric patients with community-acquired pneumonia, 
      otitis media, SSSIs and infections caused by Gram-positive resistant pathogens.
FAU - Saiman, Lisa
AU  - Saiman L
AD  - Columbia University, New York, NY, USA.
FAU - Goldfarb, Johhanna
AU  - Goldfarb J
FAU - Kaplan, Sheldon A
AU  - Kaplan SA
FAU - Wible, Kenneth
AU  - Wible K
FAU - Edge-Padbury, Barbara
AU  - Edge-Padbury B
FAU - Naberhuis-Stehouwer, Sharon
AU  - Naberhuis-Stehouwer S
FAU - Bruss, Jon B
AU  - Bruss JB
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Acetamides)
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Oxazolidinones)
RN  - 280111G160 (Cefadroxil)
RN  - ISQ9I6J12J (Linezolid)
SB  - IM
MH  - Acetamides/administration & dosage/*adverse effects/pharmacology
MH  - Administration, Oral
MH  - Adolescent
MH  - Anti-Bacterial Agents/administration & dosage/*adverse effects/pharmacology
MH  - Anti-Infective Agents/administration & dosage/*adverse effects/pharmacology
MH  - Bacteremia/drug therapy
MH  - Cefadroxil/administration & dosage/*adverse effects/pharmacology
MH  - Child
MH  - Child, Preschool
MH  - Community-Acquired Infections
MH  - Cross Infection
MH  - Diarrhea/chemically induced
MH  - Female
MH  - Gram-Positive Bacterial Infections/*drug therapy
MH  - Headache/chemically induced
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Infusions, Intravenous
MH  - Linezolid
MH  - Male
MH  - Multicenter Studies as Topic
MH  - Otitis Media/drug therapy
MH  - Oxazolidinones/administration & dosage/*adverse effects/pharmacology
MH  - Pneumonia/drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Respiratory Tract Infections/chemically induced
MH  - Skin Diseases, Bacterial/drug therapy
EDAT- 2003/10/02 05:00
MHDA- 2003/11/13 05:00
CRDT- 2003/10/02 05:00
PHST- 2003/10/02 05:00 [pubmed]
PHST- 2003/11/13 05:00 [medline]
PHST- 2003/10/02 05:00 [entrez]
AID - 10.1097/01.inf.0000087022.58089.d8 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2003 Sep;22(9 Suppl):S193-200. doi: 
      10.1097/01.inf.0000087022.58089.d8.