Safety and tolerability of ertapenem versus ceftriaxone in a double-blind study performed in children with complicated urinary tract infection, community-acquired pneumonia or skin and soft-tissue infection
Autor: | Adriano, Arguedas, Jaime, Cespedes, Francesc Aseni, Botet, Jeffrey, Blumer, Ram, Yogev, Richard, Gesser, Jean, Wang, Joseph, West, Theresa, Snyder, Wendy, Wimmer, Stefan, Zielen |
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Rok vydání: | 2008 |
Předmět: |
Microbiology (medical)
Ertapenem Male medicine.medical_specialty Carbapenem Adolescent Molecular Sequence Data beta-Lactams chemistry.chemical_compound Pharmacotherapy Community-acquired pneumonia Double-Blind Method Internal medicine polycyclic compounds medicine Pneumonia Bacterial Humans Pharmacology (medical) Adverse effect Child business.industry Soft Tissue Infections Ceftriaxone Infant General Medicine Skin Diseases Bacterial medicine.disease Surgery Anti-Bacterial Agents body regions Community-Acquired Infections Pneumonia Infectious Diseases Tolerability chemistry Child Preschool Urinary Tract Infections Female business medicine.drug |
Zdroj: | International journal of antimicrobial agents. 33(2) |
ISSN: | 0924-8579 |
Popis: | The carbapenem antibiotic ertapenem has been shown to be safe, well tolerated and effective in treating adults with complicated urinary tract infection, skin and soft-tissue infection and community-acquired pneumonia. In this study, we evaluated ertapenem for treating these infections in children in a randomised, double-blind, active-controlled clinical trial. The primary outcome was the incidence of clinical and laboratory drug-related serious adverse events (AEs). Children were randomised in a 3:1 ratio (ertapenem:ceftriaxone) stratified by index infection and age to receive ertapenem or ceftriaxone; 303 children received ertapenem and 100 children received ceftriaxone. The median duration of parenteral therapy was 4 days for both treatments. The most commonly reported drug-related clinical AEs during parenteral therapy were diarrhoea (5.9% ertapenem, 10% ceftriaxone), infusion site erythema (3% ertapenem, 2% ceftriaxone) and infusion site pain (5% ertapenem, 1% ceftriaxone). One child in each group reported a serious drug-related clinical AE. No serious drug-related laboratory AEs were reported. In children aged 3 months to 17 years, ertapenem was well tolerated and had a comparable safety profile to that of ceftriaxone. |
Databáze: | OpenAIRE |
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