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1.
Pediatr Infect Dis J ; 41(7): 556-562, 2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35675525

RESUMO

BACKGROUND: Solithromycin is a new macrolide-ketolide antibiotic with potential effectiveness in pediatric community-acquired bacterial pneumonia (CABP). Our objective was to evaluate its safety and effectiveness in children with CABP. METHODS: This phase 2/3, randomized, open-label, active-control, multicenter study randomly assigned solithromycin (capsules, suspension or intravenous) or an appropriate comparator antibiotic in a 3:1 ratio (planned n = 400) to children 2 months to 17 years of age with CABP. Primary safety endpoints included treatment-emergent adverse events (AEs) and AE-related drug discontinuations. Secondary effectiveness endpoints included clinical improvement following treatment without additional antimicrobial therapy. RESULTS: Unrelated to safety, the sponsor stopped the trial prior to completion. Before discontinuation, 97 participants were randomly assigned to solithromycin (n = 73) or comparator (n = 24). There were 24 participants (34%, 95% CI, 23%-47%) with a treatment-emergent AE in the solithromycin group and 7 (29%, 95% CI, 13%-51%) in the comparator group. Infusion site pain and elevated liver enzymes were the most common related AEs with solithromycin. Study drug was discontinued due to AEs in 3 subjects (4.3%) in the solithromycin group and 1 (4.2%) in the comparator group. Forty participants (65%, 95% CI, 51%-76%) in the solithromycin group achieved clinical improvement on the last day of treatment versus 17 (81%, 95% CI, 58%-95%) in the comparator group. The proportion achieving clinical cure was 60% (95% CI, 47%-72%) and 68% (95% CI, 43%-87%) for the solithromycin and comparator groups, respectively. CONCLUSIONS: Intravenous and oral solithromycin were generally well-tolerated and associated with clinical improvement in the majority of participants treated for CABP.


Assuntos
Infecções Comunitárias Adquiridas , Pneumonia Bacteriana , Adolescente , Antibacterianos/efeitos adversos , Criança , Infecções Comunitárias Adquiridas/tratamento farmacológico , Infecções Comunitárias Adquiridas/microbiologia , Humanos , Macrolídeos/efeitos adversos , Pneumonia Bacteriana/tratamento farmacológico , Pneumonia Bacteriana/microbiologia , Triazóis
2.
Interv Med Appl Sci ; 6(4): 187-90, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25598994

RESUMO

We present an 11-year-old male child with an enormous appendix that was regarded as an appendiceal mucocele. The disorder is very rare and usually appears in middle aged patients. It is a clinical diagnosis. It could cause a variety of symptoms, especially, acute appendicitis and unidentified lesion in the right iliac fossa. According to the reasons, it could be just a curiosity without any relevancy or the sign of a malignant lesion with bad prognostic factors. The histopathological findings prove the origin.

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