Calendario›GILD›ALPINE

ALPINE

Aztreonam Lysine for Pseudomonas Infection Eradication Study

Ensayo de GILEAD SCIENCES, INC. en Fibrosis quistica.

Más ensayos de: Fibrosis quística.

Fase

Fase 2

Estado

Completado

Participantes

105

previstos

Centros

58

Fin del objetivo primario

may 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ago 2011.

Qué mide

Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set) (del registro, en inglés) (del dia 28 al dia 196)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA. The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01375049), actualizada en jul 2014.