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

This study has been completed.
Sponsor:
Information provided by:
Novexel Inc
ClinicalTrials.gov Identifier:
NCT00653172
First received: April 1, 2008
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Community Acquired Pneumonia
Drug: NXL103
Drug: comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novexel Inc:

Primary Outcome Measures:
  • Evaluate Clinical outcome [ Time Frame: early follow up visit (day 14 to 21) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate bacteriological outcome [ Time Frame: early follow up visit (day 14 to 21) ] [ Designated as safety issue: No ]
  • Evaluate safety [ Time Frame: first dose, throughout treatment, and to follow up visit ] [ Designated as safety issue: Yes ]

Enrollment: 302
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653172

  Hide Study Locations
Locations
Chile
Hospital de Urgencia Asistencia Publica
Santiago, Chile
Complejo Asistencial Barros Luco Trudeau
Santiago, Chile
Clinica de Enfermedades Resp. "Miguel de Servet" SA
Santiago, Chile
Hospital Regional de Rancagua
Santiago, Chile
Croatia
University Hospital Dubrava
Zagreb, Croatia
General Hospital Sveti Duh
Zagreb, Croatia
Clinic for infectious diseases
Zagreb, Croatia
Estonia
Merelahe Family Doctors Centre
Tallinn, Estonia
Linnamoisa Perearstikeskus
Tallinn, Estonia
Pullerits & Peda Perearstikeskus
Tartu, Estonia
Nolvaku Family Doctor Center
Tartu, Estonia
Marje Toom Family Doctors Practice
Voru, Estonia
Germany
Penumologen=Praxis Lichterfelde
Berlin, Germany
Asklepiosklinik Wandsbeck
Hamburg, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Praxis Dr. H. Mueller
Potsdam, Germany
Praxis Dr. W. Wyborski
Werneck, Germany
Peru
Hospital Nacional Arzobispo Loayza
Lima, Peru
Hospital Nacional Guillermo Almenara
Lima, Peru
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, Poland
Romania
Spitalul Clinical Judetean de Urgenta
Brasov, Romania
Spitalul Clinic de Urgenta Bucuresti
Bucuresti, Romania
Spitalul Universitar de Urgenta Elias
Bucuresti, Romania
Centrul de Diagnostic si Tratament "Dr. Victor Babes"
Bucuresti, Romania
Spitalul Universitar de Urgenta Bucuresti
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, Romania
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
Clinresco Centres (Pty) Ltd
Gauteng, South Africa
Benmed Park Clinical
Gauteng, South Africa
Jubilee Hospital
Gauteng, South Africa
Eastmed Medical Centre
Gauteng, South Africa
Intercare-Medical & Dental Centre
Gauteng, South Africa
DJW Navorsing
Gauteng, South Africa
Sebastian, P
KZ-Natal, South Africa
Pretoria West Medicross
Pretoria West, South Africa
Clinical Project Research
Worcester, South Africa
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
F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr
Kiev, Ukraine
City Tuberculosis Hospital # 1
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
Sponsors and Collaborators
Novexel Inc
  More Information

No publications provided

Responsible Party: Dr. Carole A. Sable Chief Medical Officer, Novexel SA
ClinicalTrials.gov Identifier: NCT00653172     History of Changes
Other Study ID Numbers: NXL103/2001
Study First Received: April 1, 2008
Last Updated: January 8, 2009
Health Authority: Croatia: Ministry of Health and Social Care
Chile: Instituto de Salud Pública de Chile
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
South Africa: Medicines Control Council
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Novexel Inc:
CAP
community acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 19, 2014