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Official Title

The purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral NXL103 with oral comparator in the treatment of community acquired pneumonia in adults

Comparative Study of NXL103 versus comparator in adults with community acquired pneumonia

University Hospital Dubrava

Hospital de Urgencia Asistencia Publica

Merelahe Family Doctors Centre

Asklepios Klinik St. Georg

Hospital Nacional Arzobispo Loayza

Centrul de Diagnostic si Tratament "Dr. Victor Babes"

Spitalul Universitar de Urgenta Bucuresti

Pretoria West Medicross

Kharkiv City Clinical Hospital # 13

Complejo Asistencial Barros Luco Trudeau

Clinica de Enfermedades Resp. "Miguel de Servet" SA

Hospital Regional de Rancagua

General Hospital Sveti Duh

Clinic for infectious diseases

Linnamoisa Perearstikeskus

Pullerits & Peda Perearstikeskus

Nolvaku Family Doctor Center

Marje Toom Family Doctors Practice

Asklepiosklinik Wandsbeck

Penumologen=Praxis Lichterfelde

Praxis Dr. W. Wyborski

Praxis Dr. H. Mueller

Hospital Nacional Guillermo Almenara

Spitalul Universitar de Urgenta Elias

Spitalul Clinic de Urgenta Bucuresti

Spitalul de Pneumologie Galati

Dispensarul TB nr. 1 Galati

Spitalul Judetean de Urgenta "Sf. loan cel

Spitalul Clinical Judetean de Urgenta

Centrul Medical Privat "Medicali's"

Clinical Project Research

Benmed Park Clinical

Intercare-Medical & Dental Centre

Clinresco Centres (Pty) Ltd

GCT Trial Centre, Mercantile Hospital

DJW Navorsing

Eastmed Medical Centre

Rubins Building

Rabie, W

Jubilee Hospital

Langeberg Medical Centre

Sebastian, P

F.G. Yanovskyy Institute of P & P AMS of Ukr

F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr

City Tuberculosis Hospital # 1

DSMU n.a. M. Gorkyy, Don.Reg.Territorial Med. Clin Ass.

Iv-Frank St. Med Uni. b.o.lv Frank. Centr City Clin. Hospital

DSMA b. on Dnepropetrovsk City Clin. Hosp. #6

Nikolaev City Clinical Hospital # 1

Institute of Therapy AMS Ukr. n.a. Malaya

SP ZOZ Wielkopolskie Centrum Chrob

SP ZOZ Wojewodzki Szpital Specjalistyczny im.

NZOZ "MIG'MED"

NZOZ "ESCULAP"

NZOZ Centrum Badan Klinicznych

SPZOZ Osrodek Zdrowia wBienkowce

NZOZ Poradnia Medycyny Rodzinnej

Wojewodzki Szpital we wloclawku

Prywatny Gabinet Specjalistyczny

Indywidualna Specjalistyczna Praktyka Lekarska

A double blind, multicenter, multinational, randomized, double-dummy, three-arm parallel-group comparative study of the efficacy, safety and tolerance of oral NXL103 (500 mg twice daily) versus 
oral NXL103 (600 mg twice daily) versus 
oral Amoxicillin (1000 mg three times daily) 
in the treatment of community-acquired pneumonia in adults

Clinical outcome (cure rate based on the course of signs and symptoms reported at inclusion, changes in the X-ray findings and the need for subsequent antibiotic) at post therapy/TOC visit

Clinical outcome (cure rate based on the course of signs and symptoms reported at inclusion, changes in the X-ray findings and the need for subsequent antibiotic) at late post therapy visit

Bacteriological outcome (satisfactory rate) at the post therapy/TOC visit; PPb population

Bacteriological outcome (satisfactory rate) at the late post therapy visit; PPb population

Bacteriological response (satisfactory rate) at the post therapy/TOC visit; PPb population

Number of S. pneumoniae eradicated (includes eradication and presumed eradication) for all baseline causative pathogens

Number of H. influenzae eradicated (includes eradication and presumed eradication) for all baseline causative pathogens

Number of H. parainfluenzae eradicated (includes eradication and presumed eradication) for all baseline causative pathogens

Number of M. catarrhalis eradicated (includes eradication and presumed eradication) for all baseline causative pathogens

Number of Moraxella sp. eradicated (includes eradication and presumed eradication) for all baseline causative pathogens

Total number of pathogens eradicated (includes eradication and presumed eradication) for all baseline causative pathogens

Bacteriological response (satisfactory rate) at the late post therapy visit; PPb population

Increases greater than 3 times the upper limit of normal

Arms	Assigned Interventions
Experimental: NXL103 500 mg	Drug: NXL103 500 mg 500 mg orally twice daily
Experimental: NXL103 600 mg	Drug: NXL103 600 mg 600 mg orally twice daily
Active Comparator: Amoxicillin 1000 mg	Drug: Comparator Comparator three times daily

Comparative Study of NXL103 versus comparator in adults with community acquired pneumonia

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

University Hospital Dubrava

Hospital de Urgencia Asistencia Publica

Merelahe Family Doctors Centre

Asklepios Klinik St. Georg

Hospital Nacional Arzobispo Loayza

Centrul de Diagnostic si Tratament "Dr. Victor Babes"

Spitalul Universitar de Urgenta Bucuresti

Pretoria West Medicross

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Trial Results Summaries

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