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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | NXL103 |
|
| 3 | Active Comparator |
| |
| 2 | Experimental | NXL103 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXL103 | Drug | 600mg orally twice daily |
| |
| comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Clinical outcome | early follow up visit (day 14 to 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate bacteriological outcome | early follow up visit (day 14 to 21) | |
| Evaluate safety | first dose, throughout treatment, and to follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica de Enfermedades Resp. "Miguel de Servet" SA | Santiago | Chile | ||||
| Complejo Asistencial Barros Luco Trudeau |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 7, 2011 | |
| Unrelease | Yes |
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| Drug |
comparator twice daily |
|
| NXL103 | Drug | 500mg orally twice daily |
|
| Santiago |
| Chile |
| Hospital de Urgencia Asistencia Publica | Santiago | Chile |
| Hospital Regional de Rancagua | Santiago | Chile |
| Clinic for infectious diseases | Zagreb | Croatia |
| General Hospital Sveti Duh | Zagreb | Croatia |
| University Hospital Dubrava | Zagreb | Croatia |
| Linnamoisa Perearstikeskus | Tallinn | Estonia |
| Merelahe Family Doctors Centre | Tallinn | Estonia |
| Nolvaku Family Doctor Center | Tartu | Estonia |
| Pullerits & Peda Perearstikeskus | Tartu | Estonia |
| Marje Toom Family Doctors Practice | Võru | Estonia |
| Penumologen=Praxis Lichterfelde | Berlin | Germany |
| Asklepios Klinik St. Georg | Hamburg | Germany |
| Asklepiosklinik Wandsbeck | Hamburg | Germany |
| Praxis Dr. H. Mueller | Potsdam | Germany |
| Praxis Dr. W. Wyborski | Werneck | Germany |
| Hospital Nacional Arzobispo Loayza | Lima | Peru |
| Hospital Nacional Guillermo Almenara | Lima | Peru |
| Indywidualna Specjalistyczna Praktyka Lekarska | Bialystok | Poland |
| SP ZOZ Wojewodzki Szpital Specjalistyczny im. | Bialystok | Poland |
| SPZOZ Osrodek Zdrowia wBienkowce | Bieńkowice | Poland |
| NZOZ Poradnia Medycyny Rodzinnej | Gdansk | Poland |
| Nzoz "Esculap" | Gniewkowo | Poland |
| Prywatny Gabinet Specjalistyczny | Lodz | Poland |
| SP ZOZ Wielkopolskie Centrum Chrob | Poznan | Poland |
| Nzoz "Mig'Med" | Wąbrzeźno | Poland |
| NZOZ Centrum Badan Klinicznych | Wroclaw | Poland |
| Wojewodzki Szpital we wloclawku | Włocławek | Poland |
| Spitalul Clinical Judetean de Urgenta | Brasov | Romania |
| Centrul de Diagnostic si Tratament "Dr. Victor Babes" | Bucharest | Romania |
| Spitalul Clinic de Urgenta Bucuresti | Bucharest | Romania |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | Romania |
| Spitalul Universitar de Urgenta Elias | Bucharest | Romania |
| Dispensarul TB nr. 1 Galati | Galati | Romania |
| Spitalul de Pneumologie Galati | Galati | Romania |
| Spitalul Judetean de Urgenta "Sf. loan cel | Suceava | Romania |
| Centrul Medical Privat "Medicali's" | Timosoara | Romania |
| Langeberg Medical Centre | Cape | South Africa |
| GCT Trial Centre, Mercantile Hospital | E Cape | South Africa |
| Rabie, W | Free State | South Africa |
| Rubins Building | Free State | South Africa |
| Benmed Park Clinical | Gauteng | South Africa |
| Clinresco Centres (Pty) Ltd | Gauteng | South Africa |
| DJW Navorsing | Gauteng | South Africa |
| Eastmed Medical Centre | Gauteng | South Africa |
| Intercare-Medical & Dental Centre | Gauteng | South Africa |
| Jubilee Hospital | Gauteng | South Africa |
| Sebastian, P | KZ-Natal | South Africa |
| Pretoria West Medicross | Pretoria West | South Africa |
| Clinical Project Research | Worcester | South Africa |
| DSMA b. on Dnepropetrovsk City Clin. Hosp. #6 | Dnipro | Ukraine |
| 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 |
| Kharkiv City Clinical Hospital # 13 | Kharkiv | Ukraine |
| City Tuberculosis Hospital # 1 | Kiev | Ukraine |
| F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr | Kiev | Ukraine |
| F.G. Yanovskyy Institute of P & P AMS of Ukr | Kyiv | Ukraine |
| Institute of Therapy AMS Ukr. n.a. Malaya | Mykolayiv | Ukraine |
| Nikolaev City Clinical Hospital # 1 | Mykolayiv | Ukraine |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2011 | Yes |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C509060 | flopristin, linopristin drug combination |
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