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Comparative study of levofloxacin in the treatment of children with community-acquired pneumonia.
Pediatr Infect Dis J. 2007 Oct; 26(10):868-78.PI

Abstract

BACKGROUND

Levofloxacin has established efficacy and safety in the treatment of community-acquired pneumonia (CAP) in adults, and its use as an alternative therapy for children with CAP has been proposed.

OBJECTIVE

Assess the clinical efficacy and safety of levofloxacin compared with standard of care antibiotic therapy in the treatment of CAP in children aged 6 months to 16 years.

METHODS

In an open-label, multicenter, noninferiority trial, children with CAP were randomized 3:1 to receive levofloxacin or comparator antimicrobial therapy (0.5 to <5 years: amoxicillin/clavulanate or ceftriaxone; > or =5 years: clarithromycin or ceftriaxone with clarithromycin or erythromycin lactobinate) for 10 days. The primary outcome was cure rates at the test-of-cure visit (10-17 days after completing treatment) as determined by symptoms, physical examination, and chest radiography.

RESULTS

Seven hundred and thirty-eight children were enrolled and 539 (405 levofloxacin-treated, 134 comparator-treated) were clinically evaluable at test-of-cure visit. Clinical cure rates were 94.3% (382 of 405) in levofloxacin-treated and 94.0% (126 of 134) in comparator-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (<5 years, 92.2% versus 90.8%; > or =5 years, 96.5% versus 97.1%; respectively) and for children categorized as being at higher risk for severe disease. Mycoplasma pneumoniae was the most frequently identified cause of pneumonia (230 children). Levofloxacin was as well tolerated as comparators, with similar type and incidence of adverse events.

CONCLUSIONS

Levofloxacin was as well tolerated and effective as standard-of-care antibiotics for the treatment of CAP in infants and children.

Authors+Show Affiliations

Children's Hospital and Health Center, San Diego, CA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17901791

Citation

Bradley, John S., et al. "Comparative Study of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia." The Pediatric Infectious Disease Journal, vol. 26, no. 10, 2007, pp. 868-78.
Bradley JS, Arguedas A, Blumer JL, et al. Comparative study of levofloxacin in the treatment of children with community-acquired pneumonia. Pediatr Infect Dis J. 2007;26(10):868-78.
Bradley, J. S., Arguedas, A., Blumer, J. L., Sáez-Llorens, X., Melkote, R., & Noel, G. J. (2007). Comparative study of levofloxacin in the treatment of children with community-acquired pneumonia. The Pediatric Infectious Disease Journal, 26(10), 868-78.
Bradley JS, et al. Comparative Study of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia. Pediatr Infect Dis J. 2007;26(10):868-78. PubMed PMID: 17901791.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative study of levofloxacin in the treatment of children with community-acquired pneumonia. AU - Bradley,John S, AU - Arguedas,Adriano, AU - Blumer,Jeffrey L, AU - Sáez-Llorens,Xavier, AU - Melkote,Rama, AU - Noel,Gary J, PY - 2007/9/29/pubmed PY - 2007/12/6/medline PY - 2007/9/29/entrez SP - 868 EP - 78 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 26 IS - 10 N2 - BACKGROUND: Levofloxacin has established efficacy and safety in the treatment of community-acquired pneumonia (CAP) in adults, and its use as an alternative therapy for children with CAP has been proposed. OBJECTIVE: Assess the clinical efficacy and safety of levofloxacin compared with standard of care antibiotic therapy in the treatment of CAP in children aged 6 months to 16 years. METHODS: In an open-label, multicenter, noninferiority trial, children with CAP were randomized 3:1 to receive levofloxacin or comparator antimicrobial therapy (0.5 to <5 years: amoxicillin/clavulanate or ceftriaxone; > or =5 years: clarithromycin or ceftriaxone with clarithromycin or erythromycin lactobinate) for 10 days. The primary outcome was cure rates at the test-of-cure visit (10-17 days after completing treatment) as determined by symptoms, physical examination, and chest radiography. RESULTS: Seven hundred and thirty-eight children were enrolled and 539 (405 levofloxacin-treated, 134 comparator-treated) were clinically evaluable at test-of-cure visit. Clinical cure rates were 94.3% (382 of 405) in levofloxacin-treated and 94.0% (126 of 134) in comparator-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (<5 years, 92.2% versus 90.8%; > or =5 years, 96.5% versus 97.1%; respectively) and for children categorized as being at higher risk for severe disease. Mycoplasma pneumoniae was the most frequently identified cause of pneumonia (230 children). Levofloxacin was as well tolerated as comparators, with similar type and incidence of adverse events. CONCLUSIONS: Levofloxacin was as well tolerated and effective as standard-of-care antibiotics for the treatment of CAP in infants and children. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/17901791/Comparative_study_of_levofloxacin_in_the_treatment_of_children_with_community_acquired_pneumonia_ L2 - https://doi.org/10.1097/INF.0b013e3180cbd2c7 DB - PRIME DP - Unbound Medicine ER -