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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653172
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : January 9, 2009
Information provided by:
Novexel Inc

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
Community Acquired Pneumonia Drug: NXL103 Drug: comparator Phase 2

Study Type : Interventional  (Clinical Trial)
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 : October 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: NXL103
500mg orally twice daily
Active Comparator: 3 Drug: comparator
comparator twice daily
Experimental: 2
Drug: NXL103
600mg orally twice daily

Primary Outcome Measures :
  1. Evaluate Clinical outcome [ Time Frame: early follow up visit (day 14 to 21) ]

Secondary Outcome Measures :
  1. Evaluate bacteriological outcome [ Time Frame: early follow up visit (day 14 to 21) ]
  2. Evaluate safety [ Time Frame: first dose, throughout treatment, and to follow up visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00653172

  Hide Study Locations
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, 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
Voru, 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
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
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, 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
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
Dnepropetrovsk, Ukraine
DSMU n.a. M. Gorkyy, Don.Reg.Territorial Med. Clin Ass.
Donetsk, Ukraine
Iv-Frank St. Med Uni. 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
Sponsors and Collaborators
Novexel Inc

Responsible Party: Dr. Carole A. Sable Chief Medical Officer, Novexel SA Identifier: NCT00653172     History of Changes
Other Study ID Numbers: NXL103/2001
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009

Keywords provided by Novexel Inc:
community acquired pneumonia

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptogramin A
Anti-Bacterial Agents
Anti-Infective Agents