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

Community Acquired Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653172
• Other study ID #: NXL103/2001
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2008
• Last updated: January 8, 2009
• Start date: October 2007
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: Novexel Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social CareChile: Instituto de Salud Pública de ChileEstonia: The State Agency of MedicineGermany: Federal Institute for Drugs and Medical DevicesPeru: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySouth Africa: Medicines Control CouncilUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: November 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• NXL103
600mg orally twice daily
• comparator
comparator twice daily
• NXL103
500mg orally twice daily

Locations

Country	Name	City	State
Chile	Clinica de Enfermedades Resp. "Miguel de Servet" SA	Santiago
Chile	Complejo Asistencial Barros Luco Trudeau	Santiago
Chile	Hospital de Urgencia Asistencia Publica	Santiago
Chile	Hospital Regional de Rancagua	Santiago
Croatia	Clinic for infectious diseases	Zagreb
Croatia	General Hospital Sveti Duh	Zagreb
Croatia	University Hospital Dubrava	Zagreb
Estonia	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	Voru
Germany	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
Peru	Hospital Nacional Arzobispo Loayza	Lima
Peru	Hospital Nacional Guillermo Almenara	Lima
Poland	Indywidualna Specjalistyczna Praktyka Lekarska	Bialystok
Poland	SP ZOZ Wojewodzki Szpital Specjalistyczny im.	Bialystok
Poland	SPZOZ Osrodek Zdrowia wBienkowce	Bienkowice
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"	Wabrzezno
Poland	Wojewodzki Szpital we wloclawku	Wloclawek
Poland	NZOZ Centrum Badan Klinicznych	Wroclaw
Romania	Spitalul Clinical Judetean de Urgenta	Brasov
Romania	Centrul de Diagnostic si Tratament "Dr. Victor Babes"	Bucuresti
Romania	Spitalul Clinic de Urgenta Bucuresti	Bucuresti
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucuresti
Romania	Spitalul Universitar de Urgenta Elias	Bucuresti
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
South Africa	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
Ukraine	DSMA b. on Dnepropetrovsk City Clin. Hosp. #6	Dnepropetrovsk
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

Sponsors (1)

Lead Sponsor	Collaborator
Novexel Inc

Countries where clinical trial is conducted

Chile,  Croatia,  Estonia,  Germany,  Peru,  Poland,  Romania,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate Clinical outcome		early follow up visit (day 14 to 21)	No
Secondary	Evaluate bacteriological outcome		early follow up visit (day 14 to 21)	No
Secondary	Evaluate safety		first dose, throughout treatment, and to follow up visit	Yes