Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia

NCT ID: NCT00653172

Last Updated: 2009-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Community Acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

NXL103

Group Type EXPERIMENTAL

NXL103

Intervention Type DRUG

500mg orally twice daily

3

Group Type ACTIVE_COMPARATOR

comparator

Intervention Type DRUG

comparator twice daily

2

NXL103

Group Type EXPERIMENTAL

NXL103

Intervention Type DRUG

600mg orally twice daily

Interventions

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NXL103

600mg orally twice daily

Intervention Type DRUG

comparator

comparator twice daily

Intervention Type DRUG

NXL103

500mg orally twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Community acquired pneumonia

Exclusion Criteria

* severe CAP
* respiratory infections attributed to sources other than community acquired bacterial infection
* concomitant pulmonary disease
* history of hypersensitivity to study medication, macrolide or beta lactam antibiotics
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novexel Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Novexel SA

Locations

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Clinica de Enfermedades Resp. "Miguel de Servet" SA

Santiago, , Chile

Site Status

Complejo Asistencial Barros Luco Trudeau

Santiago, , Chile

Site Status

Hospital de Urgencia Asistencia Publica

Santiago, , Chile

Site Status

Hospital Regional de Rancagua

Santiago, , Chile

Site Status

Clinic for infectious diseases

Zagreb, , Croatia

Site Status

General Hospital Sveti Duh

Zagreb, , Croatia

Site Status

University Hospital Dubrava

Zagreb, , Croatia

Site Status

Linnamoisa Perearstikeskus

Tallinn, , Estonia

Site Status

Merelahe Family Doctors Centre

Tallinn, , Estonia

Site Status

Nolvaku Family Doctor Center

Tartu, , Estonia

Site Status

Pullerits & Peda Perearstikeskus

Tartu, , Estonia

Site Status

Marje Toom Family Doctors Practice

Võru, , Estonia

Site Status

Penumologen=Praxis Lichterfelde

Berlin, , Germany

Site Status

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status

Asklepiosklinik Wandsbeck

Hamburg, , Germany

Site Status

Praxis Dr. H. Mueller

Potsdam, , Germany

Site Status

Praxis Dr. W. Wyborski

Werneck, , Germany

Site Status

Hospital Nacional Arzobispo Loayza

Lima, , Peru

Site Status

Hospital Nacional Guillermo Almenara

Lima, , Peru

Site Status

Indywidualna Specjalistyczna Praktyka Lekarska

Bialystok, , Poland

Site Status

SP ZOZ Wojewodzki Szpital Specjalistyczny im.

Bialystok, , Poland

Site Status

SPZOZ Osrodek Zdrowia wBienkowce

Bieńkowice, , Poland

Site Status

NZOZ Poradnia Medycyny Rodzinnej

Gdansk, , Poland

Site Status

Nzoz "Esculap"

Gniewkowo, , Poland

Site Status

Prywatny Gabinet Specjalistyczny

Lodz, , Poland

Site Status

SP ZOZ Wielkopolskie Centrum Chrob

Poznan, , Poland

Site Status

Nzoz "Mig'Med"

Wąbrzeźno, , Poland

Site Status

NZOZ Centrum Badan Klinicznych

Wroclaw, , Poland

Site Status

Wojewodzki Szpital we wloclawku

Włocławek, , Poland

Site Status

Spitalul Clinical Judetean de Urgenta

Brasov, , Romania

Site Status

Centrul de Diagnostic si Tratament "Dr. Victor Babes"

Bucharest, , Romania

Site Status

Spitalul Clinic de Urgenta Bucuresti

Bucharest, , Romania

Site Status

Spitalul Universitar de Urgenta Bucuresti

Bucharest, , Romania

Site Status

Spitalul Universitar de Urgenta Elias

Bucharest, , Romania

Site Status

Dispensarul TB nr. 1 Galati

Galati, , Romania

Site Status

Spitalul de Pneumologie Galati

Galati, , Romania

Site Status

Spitalul Judetean de Urgenta "Sf. loan cel

Suceava, , Romania

Site Status

Centrul Medical Privat "Medicali's"

Timosoara, , Romania

Site Status

Langeberg Medical Centre

Cape, , South Africa

Site Status

GCT Trial Centre, Mercantile Hospital

E Cape, , South Africa

Site Status

Rabie, W

Free State, , South Africa

Site Status

Rubins Building

Free State, , South Africa

Site Status

Benmed Park Clinical

Gauteng, , South Africa

Site Status

Clinresco Centres (Pty) Ltd

Gauteng, , South Africa

Site Status

DJW Navorsing

Gauteng, , South Africa

Site Status

Eastmed Medical Centre

Gauteng, , South Africa

Site Status

Intercare-Medical & Dental Centre

Gauteng, , South Africa

Site Status

Jubilee Hospital

Gauteng, , South Africa

Site Status

Sebastian, P

KZ-Natal, , South Africa

Site Status

Pretoria West Medicross

Pretoria West, , South Africa

Site Status

Clinical Project Research

Worcester, , South Africa

Site Status

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

Dnipro, , Ukraine

Site Status

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

Donetsk, , Ukraine

Site Status

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

Frankovsk, , Ukraine

Site Status

Kharkiv City Clinical Hospital # 13

Kharkiv, , Ukraine

Site Status

City Tuberculosis Hospital # 1

Kiev, , Ukraine

Site Status

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

Kiev, , Ukraine

Site Status

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

Kyiv, , Ukraine

Site Status

Institute of Therapy AMS Ukr. n.a. Malaya

Mykolayiv, , Ukraine

Site Status

Nikolaev City Clinical Hospital # 1

Mykolayiv, , Ukraine

Site Status

Countries

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Chile Croatia Estonia Germany Peru Poland Romania South Africa Ukraine

Other Identifiers

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NXL103/2001

Identifier Type: -

Identifier Source: org_study_id

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