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

January 8, 2009 updated by: Novexel Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate Clinical outcome
Time Frame: early follow up visit (day 14 to 21)
early follow up visit (day 14 to 21)

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate bacteriological outcome
Time Frame: early follow up visit (day 14 to 21)
early follow up visit (day 14 to 21)
Evaluate safety
Time Frame: first dose, throughout treatment, and to follow up visit
first dose, throughout treatment, and to follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novexel Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2009

Last Update Submitted That Met QC Criteria

January 8, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXL103/2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe