Challenges in the design of antibiotic equivalency studies: the multicenter equivalency study of oral amoxicillin versus injectable penicillin in children aged 3-59 months with severe pneumonia

Hibberd Patricia L

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Título :	Challenges in the design of antibiotic equivalency studies: the multicenter equivalency study of oral amoxicillin versus injectable penicillin in children aged 3-59 months with severe pneumonia
Creador:	Hibberd Patricia L
Nivel de acceso:	Open access
Palabras clave :	Amoxicilina - administración y dosis Amoxicilina - uso terapéutico Niño Ensayos Clínicos como Asunto - métodos Ensayos Clínicos como Asunto - mortalidad Estudios Multicéntricos como Asunto - métodos Penicilinas - administración y dosis Penicilinas - uso terapéutico Neumonía Bacteriana - quimioterapia Proyectos de Investigación - normas Equivalencia Terapéutica Amoxicillin - Administration & dosage Amoxicillin Therapeutic use Child Clinical Trials as Topic - methods Clinical Trials as Topic Mortality Multicenter Studies as Topic - methods Penicillins - administration & dosage Penicillins Therapeutic use Pneumonia Bacterial - Drug therapy Research Design - Standards Therapeutic Equivalency
Descripción :	he World Health Organization (WHO) recommends that children with severe pneumonia (characterized by cough or difficult breathing, as well as lower chest wall indrawing) be hospitalized and treated with parenteral penicillin. Oral amoxicillin, if equally effective for treating severe pneumonia, would address challenges associated with providing parenteral therapy, including risk of transmission of bloodborne pathogens from contaminated needles, exposure to nosocomial pathogens during hospitalization, inadequate access to health care facilities, and cost. The recently completed multicenter international trial of oral amoxicillin versus parenteral penicillin for treatment of severe pneumonia demonstrated the equivalency of these agents in children with severe pneumonia. This article focuses on the challenges of designing an equivalence study and the threats to the validity of the trial results, particularly the implications of the bias toward finding equivalence when subjects are unlikely to respond to either study therapy. These considerations have implications for use of the Amoxicillin Penicillin Pneumonia International Study (APPIS) results in clinical practice and for potential modification of WHO treatment guidelines.
Colaborador(es) u otros Autores:	Patel Archana Amoxicillin Penicillin Pneumonia International Study (APPIS) Arthur Paul AddoYobo Emmanuel Yeboah-Antwi Kojo Hassan Mumtaz Jeena Prakash Coovadia Hoosan M Lozano Juan Maulen Irene McGillivray George Sukwa Tom Chisaka Noel Nguyen Ngoc Tuong Vy Thea Donald M MacLeod William B Fox Matthew Qazi Shamim FontaineGroup
Fecha de publicación :	2004
Tipo de publicación:	Artículo
Formato:	pdf
Identificador del Recurso :	10.1086/422453
Fuente:	Clinical Infectious Diseases 39(4):526-531
URI :	http://repositorio.pediatria.gob.mx:8180/handle/20.500.12103/2155
Idioma:	eng
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