CClinicalTrials.gg
CompletedNCT00653172Updated Jan 9, 2009

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

A Phase 2 interventional study of NXL103 and comparator in Community Acquired Pneumonia, sponsored by Novexel Inc. Completed at 60 sites in 9 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-01-09.

Sponsored by Novexel Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
302
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Community Acquired Pneumonia

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Keywords

  • CAP
  • community acquired pneumonia
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 302 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Novexel Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Community acquired pneumonia

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
302 participants (actual)

Study arms

  • Experimental
    1

    NXL103

    Drug: NXL103

  • Active comparator
    3

    Drug: comparator

  • Experimental
    2

    NXL103

    Drug: NXL103

Interventions

  • DrugNXL103

    600mg orally twice daily

  • Drugcomparator

    comparator twice daily

  • DrugNXL103

    500mg orally twice daily

06

What researchers measure

Primary outcomes

  1. Evaluate Clinical outcome

    Time frame: early follow up visit (day 14 to 21)

Secondary outcomes

  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

07

Study locations

60 sites
  • 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
  • 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. 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00653172
Lead sponsor
Novexel Inc
First posted
Apr 4, 2008
Start date
Oct 2007
Primary completion
Jun 2008
Completion
Nov 2008
Last update
Jan 9, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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