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MP-376

Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis

Ensayo de AMGEN INC en Fibrosis quistica.

Más ensayos de: Fibrosis quística.

Fase

Fase 1

Estado

Completado

Participantes

40

previstos

Centros

14

Fin del objetivo primario

dic 2007

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en jun 2007.

Qué mide

Safety and tolerability of MP-376 administered twice a day for 14 days (del registro, en inglés) (14 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPatients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00503490), actualizada en dic 2024.