Community Acquired PneumoniaPhase 2NCT00653172
Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia
A Phase 2 study testing NXL103 and comparator in people with Community Acquired Pneumonia, run by Novexel Inc at 60 sites in 9 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- NXL103 and comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 60 sitesin 9 countries
- Study dates
- Oct 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community acquired pneumonia
Who cannot join
- 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
Trial locations and contacts
60 sites in 9 countries.
60 sites in 9 countries
South Africa13 sites
Langeberg Medical Centre
Cape
GCT Trial Centre, Mercantile Hospital
E Cape
Rabie, W
Free State
Rubins Building
Free State
Benmed Park Clinical
Gauteng
Clinresco Centres (Pty) Ltd
Gauteng
DJW Navorsing
Gauteng
Eastmed Medical Centre
Gauteng
Intercare-Medical & Dental Centre
Gauteng
Jubilee Hospital
Gauteng
Sebastian, P
KZ-Natal
Pretoria West Medicross
Pretoria West
Clinical Project Research
Worcester
Poland10 sites
Indywidualna Specjalistyczna Praktyka Lekarska
Bialystok
SP ZOZ Wojewodzki Szpital Specjalistyczny im.
Bialystok
SPZOZ Osrodek Zdrowia wBienkowce
Bieńkowice
NZOZ Poradnia Medycyny Rodzinnej
Gdansk
Nzoz "Esculap"
Gniewkowo
Prywatny Gabinet Specjalistyczny
Lodz
SP ZOZ Wielkopolskie Centrum Chrob
Poznan
Nzoz "Mig'Med"
Wąbrzeźno
Wojewodzki Szpital we wloclawku
Włocławek
NZOZ Centrum Badan Klinicznych
Wroclaw
Romania9 sites
Spitalul Clinical Judetean de Urgenta
Brasov
Centrul de Diagnostic si Tratament "Dr. Victor Babes"
Bucharest
Spitalul Clinic de Urgenta Bucuresti
Bucharest
Spitalul Universitar de Urgenta Bucuresti
Bucharest
Spitalul Universitar de Urgenta Elias
Bucharest
Dispensarul TB nr. 1 Galati
Galati
Spitalul de Pneumologie Galati
Galati
Spitalul Judetean de Urgenta "Sf. loan cel
Suceava
Centrul Medical Privat "Medicali's"
Timosoara
Ukraine9 sites
DSMA b. on Dnepropetrovsk City Clin. Hosp. #6
Dnipro
DSMU n.a. M. Gorkyy, Don.Reg.Territorial Med. Clin Ass.
Donetsk
Iv-Frank St. Med Uni. b.o.lv Frank. Centr City Clin. Hospital
Frankovsk
Kharkiv City Clinical Hospital # 13
Kharkiv
City Tuberculosis Hospital # 1
Kiev
F.G. Yanovskyy Inst. of Ph. & Pulm. of Ac. of Med. Scien. of Ukr
Kiev
F.G. Yanovskyy Institute of P & P AMS of Ukr
Kyiv
Institute of Therapy AMS Ukr. n.a. Malaya
Mykolayiv
Nikolaev City Clinical Hospital # 1
Mykolayiv
Estonia5 sites
Linnamoisa Perearstikeskus
Tallinn
Merelahe Family Doctors Centre
Tallinn
Nolvaku Family Doctor Center
Tartu
Pullerits & Peda Perearstikeskus
Tartu
Marje Toom Family Doctors Practice
Võru
Germany5 sites
Penumologen=Praxis Lichterfelde
Berlin
Asklepios Klinik St. Georg
Hamburg
Asklepiosklinik Wandsbeck
Hamburg
Praxis Dr. H. Mueller
Potsdam
Praxis Dr. W. Wyborski
Werneck
Chile4 sites
Clinica de Enfermedades Resp. "Miguel de Servet" SA
Santiago
Complejo Asistencial Barros Luco Trudeau
Santiago
Hospital de Urgencia Asistencia Publica
Santiago
Hospital Regional de Rancagua
Santiago
Croatia3 sites
Clinic for infectious diseases
Zagreb
General Hospital Sveti Duh
Zagreb
University Hospital Dubrava
Zagreb
Peru2 sites
Hospital Nacional Arzobispo Loayza
Lima
Hospital Nacional Guillermo Almenara
Lima
About this study
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
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
- Conditions
- Community Acquired Pneumonia
- Being tested
- NXL103, comparator
- Keywords
- CAP, community acquired pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXL103Drug
600mg orally twice daily
comparatorDrug
comparator twice daily
NXL103Drug
500mg orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NXL103 Receives: Drug: NXL103 |
| 3 | Active comparator | Not described Receives: Drug: comparator |
| 2 | Experimental | NXL103 Receives: Drug: NXL103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Clinical outcome
Measured: early follow up visit (day 14 to 21)
Secondary outcomes (2)
Evaluate bacteriological outcome
Measured: early follow up visit (day 14 to 21)
Evaluate safety
Measured: first dose, throughout treatment, and to follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novexel Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653172
- Sponsor's protocol ID
- NXL103/2001
- Status last verified
- Jan 2009
- First submitted
- 1 Apr 2008
- Last updated
- 9 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00653172
- Acronym / sponsor ID
- NXL103/2001
- Conditions
- Community Acquired Pneumonia
- Keywords
- CAP, community acquired pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Novexel IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NXL103NXL103 |
| 3 | Active comparator | Drug: comparator |
| 2 | Experimental | Drug: NXL103NXL103 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community acquired pneumonia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NXL103600mg orally twice daily | Drug | 2 |
| comparatorcomparator twice daily | Drug | 3 |
| NXL103500mg orally twice daily | Drug | 1 |
Primary outcome
Evaluate Clinical outcome
Time frame: early follow up visit (day 14 to 21)
2 secondary outcomes
Evaluate bacteriological outcome
Time frame: early follow up visit (day 14 to 21)
Evaluate safety
Time frame: first dose, throughout treatment, and to follow up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2009.
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Local Antibiotic Delivery for Community Acquired Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NXL103 and comparator in people with Community Acquired Pneumonia, run by Novexel Inc at 60 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in South Africa, Poland, Romania, Ukraine, Estonia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Clinical outcome (time frame: early follow up visit (day 14 to 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2009.