Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia
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
1 other identifier
interventional
302
9 countries
60
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJanuary 9, 2009
January 1, 2009
8 months
April 1, 2008
January 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate Clinical outcome
early follow up visit (day 14 to 21)
Secondary Outcomes (2)
Evaluate bacteriological outcome
early follow up visit (day 14 to 21)
Evaluate safety
first dose, throughout treatment, and to follow up visit
Study Arms (3)
1
EXPERIMENTALNXL103
3
ACTIVE COMPARATOR2
EXPERIMENTALNXL103
Interventions
Eligibility Criteria
You may qualify if:
- Community acquired pneumonia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novexel Inclead
Study Sites (60)
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
Võru, 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
Bieńkowice, 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"
Wąbrzeźno, Poland
NZOZ Centrum Badan Klinicznych
Wroclaw, Poland
Wojewodzki Szpital we wloclawku
Włocławek, Poland
Spitalul Clinical Judetean de Urgenta
Brasov, Romania
Centrul de Diagnostic si Tratament "Dr. Victor Babes"
Bucharest, Romania
Spitalul Clinic de Urgenta Bucuresti
Bucharest, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, Romania
Spitalul Universitar de Urgenta Elias
Bucharest, 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
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
Dnipro, 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, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 4, 2008
Study Start
October 1, 2007
Primary Completion
June 1, 2008
Study Completion
November 1, 2008
Last Updated
January 9, 2009
Record last verified: 2009-01