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

Phase 2

Completed

• Conditions: Community Acquired Pneumonia
• Interventions: Drug: NXL103; Drug: comparator

• Registration Number: NCT00653172
• Lead Sponsor: Novexel Inc

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Primary Completion: 2008-06
• Study Completion: 2008-11
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-08
• Last Update Posted: 2009-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	NXL103	NXL103
1	NXL103	NXL103
3	comparator	-

Primary Outcome Measures

Name	Time	Method
Evaluate Clinical outcome	early follow up visit (day 14 to 21)

Secondary Outcome Measures

Name	Time	Method
Evaluate bacteriological outcome	early follow up visit (day 14 to 21)
Evaluate safety	first dose, throughout treatment, and to follow up visit

Trial Locations

Locations (60)

Linnamoisa Perearstikeskus; 🇪🇪 Tallinn, Estonia

Nolvaku Family Doctor Center; 🇪🇪 Tartu, Estonia

Clinica de Enfermedades Resp. "Miguel de Servet" SA; 🇨🇱 Santiago, Chile

Hospital de Urgencia Asistencia Publica; 🇨🇱 Santiago, Chile

Hospital Regional de Rancagua; 🇨🇱 Santiago, Chile

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia

Pullerits & Peda Perearstikeskus; 🇪🇪 Tartu, Estonia

General Hospital Sveti Duh; 🇭🇷 Zagreb, Croatia

SP ZOZ Wojewodzki Szpital Specjalistyczny im.; 🇵🇱 Bialystok, Poland

SP ZOZ Wielkopolskie Centrum Chrob; 🇵🇱 Poznan, Poland

Praxis Dr. W. Wyborski; 🇩🇪 Werneck, Germany

Merelahe Family Doctors Centre; 🇪🇪 Tallinn, Estonia

Hospital Nacional Guillermo Almenara; 🇵🇪 Lima, Peru

NZOZ Poradnia Medycyny Rodzinnej; 🇵🇱 Gdansk, Poland

Nzoz "Esculap"; 🇵🇱 Gniewkowo, Poland

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Praxis Dr. H. Mueller; 🇩🇪 Potsdam, Germany

Hospital Nacional Arzobispo Loayza; 🇵🇪 Lima, Peru

Indywidualna Specjalistyczna Praktyka Lekarska; 🇵🇱 Bialystok, Poland

Asklepiosklinik Wandsbeck; 🇩🇪 Hamburg, Germany

SPZOZ Osrodek Zdrowia wBienkowce; 🇵🇱 Bienkowice, Poland

Prywatny Gabinet Specjalistyczny; 🇵🇱 Lodz, Poland

Centrul de Diagnostic si Tratament "Dr. Victor Babes"; 🇷🇴 Bucuresti, Romania

Nzoz "Mig'Med"; 🇵🇱 Wabrzezno, Poland

Spitalul de Pneumologie Galati; 🇷🇴 Galati, Romania

Centrul Medical Privat "Medicali's"; 🇷🇴 Timosoara, Romania

Wojewodzki Szpital we wloclawku; 🇵🇱 Wloclawek, Poland

NZOZ Centrum Badan Klinicznych; 🇵🇱 Wroclaw, Poland

Dispensarul TB nr. 1 Galati; 🇷🇴 Galati, Romania

Spitalul Clinical Judetean de Urgenta; 🇷🇴 Brasov, Romania

Spitalul Clinic de Urgenta Bucuresti; 🇷🇴 Bucuresti, Romania

Spitalul Universitar de Urgenta Bucuresti; 🇷🇴 Bucuresti, Romania

Spitalul Universitar de Urgenta Elias; 🇷🇴 Bucuresti, Romania

Penumologen=Praxis Lichterfelde; 🇩🇪 Berlin, Germany

Langeberg Medical Centre; 🇿🇦 Cape, South Africa

Clinical Project Research; 🇿🇦 Worcester, South Africa

Pretoria West Medicross; 🇿🇦 Pretoria West, South Africa

Complejo Asistencial Barros Luco Trudeau; 🇨🇱 Santiago, Chile

Clinic for infectious diseases; 🇭🇷 Zagreb, Croatia

Benmed Park Clinical; 🇿🇦 Gauteng, South Africa

Rubins Building; 🇿🇦 Free State, South Africa

GCT Trial Centre, Mercantile Hospital; 🇿🇦 E Cape, South Africa

Rabie, W; 🇿🇦 Free State, South Africa

Clinresco Centres (Pty) Ltd; 🇿🇦 Gauteng, South Africa

Marje Toom Family Doctors Practice; 🇪🇪 Voru, Estonia

Spitalul Judetean de Urgenta "Sf. loan cel; 🇷🇴 Suceava, Romania

DJW Navorsing; 🇿🇦 Gauteng, South Africa

Eastmed Medical Centre; 🇿🇦 Gauteng, South Africa

Intercare-Medical & Dental Centre; 🇿🇦 Gauteng, South Africa

DSMA b. on Dnepropetrovsk City Clin. Hosp. #6; 🇺🇦 Dnepropetrovsk, Ukraine

Jubilee Hospital; 🇿🇦 Gauteng, South Africa

Sebastian, P; 🇿🇦 KZ-Natal, South Africa

DSMU n.a. M. Gorkyy, Don.Reg.Territorial Med. Clin Ass.; 🇺🇦 Donetsk, Ukraine

Iv-Frank St. Med Uni. b.o.lv Frank. Centr City Clin. Hospital; 🇺🇦 Frankovsk, Ukraine

City Tuberculosis Hospital # 1; 🇺🇦 Kiev, Ukraine

Kharkiv City Clinical Hospital # 13; 🇺🇦 Kharkiv, Ukraine

F.G. Yanovskyy Institute of P & P AMS of Ukr; 🇺🇦 Kyiv, Ukraine

F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr; 🇺🇦 Kiev, Ukraine

Nikolaev City Clinical Hospital # 1; 🇺🇦 Mykolayiv, Ukraine

Institute of Therapy AMS Ukr. n.a. Malaya; 🇺🇦 Mykolayiv, Ukraine