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

Primary Purpose

Community Acquired Pneumonia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NXL103
comparator
NXL103
Sponsored by
Novexel Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Pneumonia focused on measuring CAP, community acquired pneumonia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica de Enfermedades Resp. "Miguel de Servet" SA
  • Complejo Asistencial Barros Luco Trudeau
  • Hospital de Urgencia Asistencia Publica
  • Hospital Regional de Rancagua
  • Clinic for infectious diseases
  • General Hospital Sveti Duh
  • University Hospital Dubrava
  • Linnamoisa Perearstikeskus
  • Merelahe Family Doctors Centre
  • Nolvaku Family Doctor Center
  • Pullerits & Peda Perearstikeskus
  • Marje Toom Family Doctors Practice
  • Penumologen=Praxis Lichterfelde
  • Asklepios Klinik St. Georg
  • Asklepiosklinik Wandsbeck
  • Praxis Dr. H. Mueller
  • Praxis Dr. W. Wyborski
  • Hospital Nacional Arzobispo Loayza
  • Hospital Nacional Guillermo Almenara
  • Indywidualna Specjalistyczna Praktyka Lekarska
  • SP ZOZ Wojewodzki Szpital Specjalistyczny im.
  • SPZOZ Osrodek Zdrowia wBienkowce
  • NZOZ Poradnia Medycyny Rodzinnej
  • Nzoz "Esculap"
  • Prywatny Gabinet Specjalistyczny
  • SP ZOZ Wielkopolskie Centrum Chrob
  • Nzoz "Mig'Med"
  • Wojewodzki Szpital we wloclawku
  • NZOZ Centrum Badan Klinicznych
  • Spitalul Clinical Judetean de Urgenta
  • Centrul de Diagnostic si Tratament "Dr. Victor Babes"
  • Spitalul Clinic de Urgenta Bucuresti
  • Spitalul Universitar de Urgenta Bucuresti
  • Spitalul Universitar de Urgenta Elias
  • Dispensarul TB nr. 1 Galati
  • Spitalul de Pneumologie Galati
  • Spitalul Judetean de Urgenta "Sf. loan cel
  • Centrul Medical Privat "Medicali's"
  • Langeberg Medical Centre
  • GCT Trial Centre, Mercantile Hospital
  • Rabie, W
  • Rubins Building
  • Benmed Park Clinical
  • Clinresco Centres (Pty) Ltd
  • DJW Navorsing
  • Eastmed Medical Centre
  • Intercare-Medical & Dental Centre
  • Jubilee Hospital
  • Sebastian, P
  • Pretoria West Medicross
  • Clinical Project Research
  • DSMA b. on Dnepropetrovsk City Clin. Hosp. #6
  • DSMU n.a. M. Gorkyy, Don.Reg.Territorial Med. Clin Ass.
  • Iv-Frank St. Med Uni. b.o.lv Frank. Centr City Clin. Hospital
  • Kharkiv City Clinical Hospital # 13
  • City Tuberculosis Hospital # 1
  • F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr
  • F.G. Yanovskyy Institute of P & P AMS of Ukr
  • Institute of Therapy AMS Ukr. n.a. Malaya
  • Nikolaev City Clinical Hospital # 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

1

3

2

Arm Description

NXL103

NXL103

Outcomes

Primary Outcome Measures

Evaluate Clinical outcome

Secondary Outcome Measures

Evaluate bacteriological outcome
Evaluate safety

Full Information

First Posted
April 1, 2008
Last Updated
January 8, 2009
Sponsor
Novexel Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00653172
Brief Title
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

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novexel Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia
Keywords
CAP, community acquired pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
NXL103
Arm Title
3
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
NXL103
Intervention Type
Drug
Intervention Name(s)
NXL103
Intervention Description
600mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
comparator
Intervention Description
comparator twice daily
Intervention Type
Drug
Intervention Name(s)
NXL103
Intervention Description
500mg orally twice daily
Primary Outcome Measure Information:
Title
Evaluate Clinical outcome
Time Frame
early follow up visit (day 14 to 21)
Secondary Outcome Measure Information:
Title
Evaluate bacteriological outcome
Time Frame
early follow up visit (day 14 to 21)
Title
Evaluate safety
Time Frame
first dose, throughout treatment, and to follow up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinica de Enfermedades Resp. "Miguel de Servet" SA
City
Santiago
Country
Chile
Facility Name
Complejo Asistencial Barros Luco Trudeau
City
Santiago
Country
Chile
Facility Name
Hospital de Urgencia Asistencia Publica
City
Santiago
Country
Chile
Facility Name
Hospital Regional de Rancagua
City
Santiago
Country
Chile
Facility Name
Clinic for infectious diseases
City
Zagreb
Country
Croatia
Facility Name
General Hospital Sveti Duh
City
Zagreb
Country
Croatia
Facility Name
University Hospital Dubrava
City
Zagreb
Country
Croatia
Facility Name
Linnamoisa Perearstikeskus
City
Tallinn
Country
Estonia
Facility Name
Merelahe Family Doctors Centre
City
Tallinn
Country
Estonia
Facility Name
Nolvaku Family Doctor Center
City
Tartu
Country
Estonia
Facility Name
Pullerits & Peda Perearstikeskus
City
Tartu
Country
Estonia
Facility Name
Marje Toom Family Doctors Practice
City
Voru
Country
Estonia
Facility Name
Penumologen=Praxis Lichterfelde
City
Berlin
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
Country
Germany
Facility Name
Asklepiosklinik Wandsbeck
City
Hamburg
Country
Germany
Facility Name
Praxis Dr. H. Mueller
City
Potsdam
Country
Germany
Facility Name
Praxis Dr. W. Wyborski
City
Werneck
Country
Germany
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara
City
Lima
Country
Peru
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska
City
Bialystok
Country
Poland
Facility Name
SP ZOZ Wojewodzki Szpital Specjalistyczny im.
City
Bialystok
Country
Poland
Facility Name
SPZOZ Osrodek Zdrowia wBienkowce
City
Bienkowice
Country
Poland
Facility Name
NZOZ Poradnia Medycyny Rodzinnej
City
Gdansk
Country
Poland
Facility Name
Nzoz "Esculap"
City
Gniewkowo
Country
Poland
Facility Name
Prywatny Gabinet Specjalistyczny
City
Lodz
Country
Poland
Facility Name
SP ZOZ Wielkopolskie Centrum Chrob
City
Poznan
Country
Poland
Facility Name
Nzoz "Mig'Med"
City
Wabrzezno
Country
Poland
Facility Name
Wojewodzki Szpital we wloclawku
City
Wloclawek
Country
Poland
Facility Name
NZOZ Centrum Badan Klinicznych
City
Wroclaw
Country
Poland
Facility Name
Spitalul Clinical Judetean de Urgenta
City
Brasov
Country
Romania
Facility Name
Centrul de Diagnostic si Tratament "Dr. Victor Babes"
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic de Urgenta Bucuresti
City
Bucuresti
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucuresti
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Elias
City
Bucuresti
Country
Romania
Facility Name
Dispensarul TB nr. 1 Galati
City
Galati
Country
Romania
Facility Name
Spitalul de Pneumologie Galati
City
Galati
Country
Romania
Facility Name
Spitalul Judetean de Urgenta "Sf. loan cel
City
Suceava
Country
Romania
Facility Name
Centrul Medical Privat "Medicali's"
City
Timosoara
Country
Romania
Facility Name
Langeberg Medical Centre
City
Cape
Country
South Africa
Facility Name
GCT Trial Centre, Mercantile Hospital
City
E Cape
Country
South Africa
Facility Name
Rabie, W
City
Free State
Country
South Africa
Facility Name
Rubins Building
City
Free State
Country
South Africa
Facility Name
Benmed Park Clinical
City
Gauteng
Country
South Africa
Facility Name
Clinresco Centres (Pty) Ltd
City
Gauteng
Country
South Africa
Facility Name
DJW Navorsing
City
Gauteng
Country
South Africa
Facility Name
Eastmed Medical Centre
City
Gauteng
Country
South Africa
Facility Name
Intercare-Medical & Dental Centre
City
Gauteng
Country
South Africa
Facility Name
Jubilee Hospital
City
Gauteng
Country
South Africa
Facility Name
Sebastian, P
City
KZ-Natal
Country
South Africa
Facility Name
Pretoria West Medicross
City
Pretoria West
Country
South Africa
Facility Name
Clinical Project Research
City
Worcester
Country
South Africa
Facility Name
DSMA b. on Dnepropetrovsk City Clin. Hosp. #6
City
Dnepropetrovsk
Country
Ukraine
Facility Name
DSMU n.a. M. Gorkyy, Don.Reg.Territorial Med. Clin Ass.
City
Donetsk
Country
Ukraine
Facility Name
Iv-Frank St. Med Uni. b.o.lv Frank. Centr City Clin. Hospital
City
Frankovsk
Country
Ukraine
Facility Name
Kharkiv City Clinical Hospital # 13
City
Kharkiv
Country
Ukraine
Facility Name
City Tuberculosis Hospital # 1
City
Kiev
Country
Ukraine
Facility Name
F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr
City
Kiev
Country
Ukraine
Facility Name
F.G. Yanovskyy Institute of P & P AMS of Ukr
City
Kyiv
Country
Ukraine
Facility Name
Institute of Therapy AMS Ukr. n.a. Malaya
City
Mykolayiv
Country
Ukraine
Facility Name
Nikolaev City Clinical Hospital # 1
City
Mykolayiv
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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