Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia
Sponsor
Novexel Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00653172
Collaborator
(none)
302
60
3
13
5
0.4
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
302 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Multicenter, Randomized, Double Dummy, Three-Arm Parallel-Group Comparative Study of the Efficacy, Safety and Tolerance of Oral NXL 103 Versus Oral Comparator in the Treatment of Community-Acquired Pneumonia in Adults
Study Start Date
:
Oct 1, 2007
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
Nov 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 NXL103 |
Drug: NXL103
500mg orally twice daily
|
| Active Comparator: 3
|
Drug: comparator
comparator twice daily
|
| Experimental: 2 NXL103 |
Drug: NXL103
600mg orally twice daily
|
Outcome Measures
Primary Outcome Measures
- Evaluate Clinical outcome [early follow up visit (day 14 to 21)]
Secondary Outcome Measures
- Evaluate bacteriological outcome [early follow up visit (day 14 to 21)]
- Evaluate safety [first dose, throughout treatment, and to follow up visit]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinica de Enfermedades Resp. "Miguel de Servet" SA | Santiago | Chile | ||
| 2 | Complejo Asistencial Barros Luco Trudeau | Santiago | Chile | ||
| 3 | Hospital de Urgencia Asistencia Publica | Santiago | Chile | ||
| 4 | Hospital Regional de Rancagua | Santiago | Chile | ||
| 5 | Clinic for infectious diseases | Zagreb | Croatia | ||
| 6 | General Hospital Sveti Duh | Zagreb | Croatia | ||
| 7 | University Hospital Dubrava | Zagreb | Croatia | ||
| 8 | Linnamoisa Perearstikeskus | Tallinn | Estonia | ||
| 9 | Merelahe Family Doctors Centre | Tallinn | Estonia | ||
| 10 | Nolvaku Family Doctor Center | Tartu | Estonia | ||
| 11 | Pullerits & Peda Perearstikeskus | Tartu | Estonia | ||
| 12 | Marje Toom Family Doctors Practice | Voru | Estonia | ||
| 13 | Penumologen=Praxis Lichterfelde | Berlin | Germany | ||
| 14 | Asklepios Klinik St. Georg | Hamburg | Germany | ||
| 15 | Asklepiosklinik Wandsbeck | Hamburg | Germany | ||
| 16 | Praxis Dr. H. Mueller | Potsdam | Germany | ||
| 17 | Praxis Dr. W. Wyborski | Werneck | Germany | ||
| 18 | Hospital Nacional Arzobispo Loayza | Lima | Peru | ||
| 19 | Hospital Nacional Guillermo Almenara | Lima | Peru | ||
| 20 | Indywidualna Specjalistyczna Praktyka Lekarska | Bialystok | Poland | ||
| 21 | SP ZOZ Wojewodzki Szpital Specjalistyczny im. | Bialystok | Poland | ||
| 22 | SPZOZ Osrodek Zdrowia wBienkowce | Bienkowice | Poland | ||
| 23 | NZOZ Poradnia Medycyny Rodzinnej | Gdansk | Poland | ||
| 24 | Nzoz "Esculap" | Gniewkowo | Poland | ||
| 25 | Prywatny Gabinet Specjalistyczny | Lodz | Poland | ||
| 26 | SP ZOZ Wielkopolskie Centrum Chrob | Poznan | Poland | ||
| 27 | Nzoz "Mig'Med" | Wabrzezno | Poland | ||
| 28 | Wojewodzki Szpital we wloclawku | Wloclawek | Poland | ||
| 29 | NZOZ Centrum Badan Klinicznych | Wroclaw | Poland | ||
| 30 | Spitalul Clinical Judetean de Urgenta | Brasov | Romania | ||
| 31 | Centrul de Diagnostic si Tratament "Dr. Victor Babes" | Bucuresti | Romania | ||
| 32 | Spitalul Clinic de Urgenta Bucuresti | Bucuresti | Romania | ||
| 33 | Spitalul Universitar de Urgenta Bucuresti | Bucuresti | Romania | ||
| 34 | Spitalul Universitar de Urgenta Elias | Bucuresti | Romania | ||
| 35 | Dispensarul TB nr. 1 Galati | Galati | Romania | ||
| 36 | Spitalul de Pneumologie Galati | Galati | Romania | ||
| 37 | Spitalul Judetean de Urgenta "Sf. loan cel | Suceava | Romania | ||
| 38 | Centrul Medical Privat "Medicali's" | Timosoara | Romania | ||
| 39 | Langeberg Medical Centre | Cape | South Africa | ||
| 40 | GCT Trial Centre, Mercantile Hospital | E Cape | South Africa | ||
| 41 | Rabie, W | Free State | South Africa | ||
| 42 | Rubins Building | Free State | South Africa | ||
| 43 | Benmed Park Clinical | Gauteng | South Africa | ||
| 44 | Clinresco Centres (Pty) Ltd | Gauteng | South Africa | ||
| 45 | DJW Navorsing | Gauteng | South Africa | ||
| 46 | Eastmed Medical Centre | Gauteng | South Africa | ||
| 47 | Intercare-Medical & Dental Centre | Gauteng | South Africa | ||
| 48 | Jubilee Hospital | Gauteng | South Africa | ||
| 49 | Sebastian, P | KZ-Natal | South Africa | ||
| 50 | Pretoria West Medicross | Pretoria West | South Africa | ||
| 51 | Clinical Project Research | Worcester | South Africa | ||
| 52 | DSMA b. on Dnepropetrovsk City Clin. Hosp. #6 | Dnepropetrovsk | Ukraine | ||
| 53 | DSMU n.a. M. Gorkyy, Don.Reg.Territorial Med. Clin Ass. | Donetsk | Ukraine | ||
| 54 | Iv-Frank St. Med Uni. b.o.lv Frank. Centr City Clin. Hospital | Frankovsk | Ukraine | ||
| 55 | Kharkiv City Clinical Hospital # 13 | Kharkiv | Ukraine | ||
| 56 | City Tuberculosis Hospital # 1 | Kiev | Ukraine | ||
| 57 | F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr | Kiev | Ukraine | ||
| 58 | F.G. Yanovskyy Institute of P & P AMS of Ukr | Kyiv | Ukraine | ||
| 59 | Institute of Therapy AMS Ukr. n.a. Malaya | Mykolayiv | Ukraine | ||
| 60 | Nikolaev City Clinical Hospital # 1 | Mykolayiv | Ukraine |
Sponsors and Collaborators
- Novexel Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00653172
Other Study ID Numbers:
- NXL103/2001
First Posted:
Apr 4, 2008
Last Update Posted:
Jan 9, 2009
Last Verified:
Jan 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: