A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

CompletadoFase 3ClinicalTrials.gov

ID: NCT00643227Tipo: INTERVENTIONALInicio: 1 de ene de 2003Fin estimado: 1 de mar de 2004

Traducción no disponible, mostrando original

Resumen

The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC \>10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).

Criterios de exclusión

Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.

Intervenciones

drug

clarithromycin extended release (ER)

7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily

drug

azithromycin SR

Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

Ubicaciones

Pfizer Investigational Site

Tandil, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Multicenter, Randomized, Double-Blind, Double-Dummy Com... | EligiMed