Clinical trial NCT00653172: Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Community Acquired Pneumonia
Keywords: CAP
community acquired pneumonia
Lead sponsor: Novexel Inc
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate Clinical outcome
timeFrame: early follow up visit (day 14 to 21)
Secondary outcomes:
measure: Evaluate bacteriological outcome
timeFrame: early follow up visit (day 14 to 21)
measure: Evaluate safety
timeFrame: first dose, throughout treatment, and to follow up visit
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica de Enfermedades Resp. "Miguel de Servet" SA
city: Santiago
country: Chile
facility: Complejo Asistencial Barros Luco Trudeau
city: Santiago
country: Chile
facility: Hospital de Urgencia Asistencia Publica
city: Santiago
country: Chile
facility: Hospital Regional de Rancagua
city: Zagreb
country: Croatia
facility: Clinic for infectious diseases
city: Zagreb
country: Croatia
facility: General Hospital Sveti Duh
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Tallinn
country: Estonia
facility: Linnamoisa Perearstikeskus
city: Tallinn
country: Estonia
facility: Merelahe Family Doctors Centre
city: Tartu
country: Estonia
facility: Nolvaku Family Doctor Center
city: Tartu
country: Estonia
facility: Pullerits & Peda Perearstikeskus
city: Voru
country: Estonia
facility: Marje Toom Family Doctors Practice
city: Berlin
country: Germany
facility: Penumologen=Praxis Lichterfelde
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Asklepiosklinik Wandsbeck
city: Potsdam
country: Germany
facility: Praxis Dr. H. Mueller
city: Werneck
country: Germany
facility: Praxis Dr. W. Wyborski
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara
city: Bialystok
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
city: Bialystok
country: Poland
facility: SP ZOZ Wojewodzki Szpital Specjalistyczny im.
city: Bienkowice
country: Poland
facility: SPZOZ Osrodek Zdrowia wBienkowce
city: Gdansk
country: Poland
facility: NZOZ Poradnia Medycyny Rodzinnej
city: Gniewkowo
country: Poland
facility: Nzoz "Esculap"
city: Lodz
country: Poland
facility: Prywatny Gabinet Specjalistyczny
city: Poznan
country: Poland
facility: SP ZOZ Wielkopolskie Centrum Chrob
city: Wabrzezno
country: Poland
facility: Nzoz "Mig'Med"
city: Wloclawek
country: Poland
facility: Wojewodzki Szpital we wloclawku
city: Wroclaw
country: Poland
facility: NZOZ Centrum Badan Klinicznych
city: Brasov
country: Romania
facility: Spitalul Clinical Judetean de Urgenta
city: Bucuresti
country: Romania
facility: Centrul de Diagnostic si Tratament "Dr. Victor Babes"
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta Bucuresti
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Elias
city: Galati
country: Romania
facility: Dispensarul TB nr. 1 Galati
city: Galati
country: Romania
facility: Spitalul de Pneumologie Galati
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta "Sf. loan cel
city: Timosoara
country: Romania
facility: Centrul Medical Privat "Medicali's"
city: Cape
country: South Africa
facility: Langeberg Medical Centre
city: E Cape
country: South Africa
facility: GCT Trial Centre, Mercantile Hospital
city: Free State
country: South Africa
facility: Rabie, W
city: Free State
country: South Africa
facility: Rubins Building
city: Gauteng
country: South Africa
facility: Benmed Park Clinical
city: Gauteng
country: South Africa
facility: Clinresco Centres (Pty) Ltd
city: Gauteng
country: South Africa
facility: DJW Navorsing
city: Gauteng
country: South Africa
facility: Eastmed Medical Centre
city: Gauteng
country: South Africa
facility: Intercare-Medical & Dental Centre
city: Gauteng
country: South Africa
facility: Jubilee Hospital
city: KZ-Natal
country: South Africa
facility: Sebastian, P
city: Pretoria West
country: South Africa
facility: Pretoria West Medicross
city: Worcester
country: South Africa
facility: Clinical Project Research
city: Dnepropetrovsk
country: Ukraine
facility: DSMA b. on Dnepropetrovsk City Clin. Hosp. #6
city: Donetsk
country: Ukraine
facility: DSMU n.a. M. Gorkyy, Don.Reg.Territorial Med. Clin Ass.
city: Frankovsk
country: Ukraine
facility: Iv-Frank St. Med Uni. b.o.lv Frank. Centr City Clin. Hospital
city: Kharkiv
country: Ukraine
facility: Kharkiv City Clinical Hospital # 13
city: Kiev
country: Ukraine
facility: City Tuberculosis Hospital # 1
city: Kiev
country: Ukraine
facility: F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr
city: Kyiv
country: Ukraine
facility: F.G. Yanovskyy Institute of P & P AMS of Ukr
city: Mykolayiv
country: Ukraine
facility: Institute of Therapy AMS Ukr. n.a. Malaya
city: Mykolayiv
country: Ukraine
facility: Nikolaev City Clinical Hospital # 1
Study officials:
References: