Pneumonia, Ventilator-AssociatedPhase 2NCT00610623
Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
A Phase 2 study testing azithromycin in people with Pneumonia, Ventilator-Associated and Pseudomonas Infections, run by Anbics Management-Services Ag at 20 sites in 6 countries.
Trial summary
The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Pseudomonas Infections
- What is being tested?
- azithromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 20 sitesin 6 countries
- Study dates
- Apr 2003to Oct 2005
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non pregnant female aged 18 to 75 years
- Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more
- Reasonable survival chance within next few days with an Apache score 10-25
- Tracheal aspirate found positive for P. aeruginosa
- The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent
- Informed consent must be obtained for all subjects before enrollment in the study, by patient or by a close family member
Who cannot join
- Poor prognosis as judged by Apache score II score >25
- Pregnant female
- Grossly under-or overweight (BMI<18or >29)
- Ongoing therapy with a macrolide
- Known allergy to any macrolide
- Proven P. aeruginosa pneumonia
Show all 13Show fewer
- Ongoing anti-pseudomonal therapy with a proven susceptible colonizing strain
- Anticipated short duration of mechanical ventilation (<3 days)
- Known drug interaction that could either decrease efficacy or raise safety concerns
- Severe hepatic failure (type C, score >10 on Child Pugh scale)
- Sick sinus syndrome or long QT syndrome
- Recent donation of blood or participation in another clinical trial within 3 months
- Any situation exposing the patient to higher risk or possibly confounding results
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
France8 sites
Intensive Care Unit, Jean Minjoz University Hospital
Besançon, Besancon, 25030
Intensive Car Unit, Calmette University Hospital of Lille
Lille, Lille, 59037
Medical-surgical intensive car unit, Dupuytren Teaching Hospital
Limoges, Limoges, 8700
General Intensive Care Unit, Montauban City Hospital
Montauban, Montauban, 82013
Medical Intensive Car Unit, Hospital Bichat
Paris, Paris, 75018
Surgical Intensive Car Unit; University Hospital Bichat
Paris, Paris, 75018
General Intensive Care Unit, Hospital Saint-Joseph
Paris, Paris, 75674
Medical Intensive Care Unit, Cochin Hospital
Paris, Paris, 75679
Spain4 sites
Intensive Care Unit, Hospital del Mar
Barcelona, Barcelona, 08003
Internal Medicine, Vall d'Hebron Hospital
Barcelona, Barcelona, 08035
Intensive Care Unit, San Dureta University Hospital
Palma de Mallorca, 07014
Intensive Care Unit, Joan XXIII University Hospital
Tarragona, Tarragona, 43007
Poland3 sites
Intensive Care Unit, Wojewodzki Hospital
Krakow
Intensive Care Unit, Wojewodzki Hospital
Sosnowiec
Intensive Care Unit, Central Hospital
Warsaw
Belgium2 sites
General Intensive Car Unit, Centre Hospitalier Universitaire de Liège
Liège, Liège, B-4000
Intensive Care Unit, Clinique Saint-Pierre
Ottignies, Louvain, 1340
Serbia and Montenegro2 sites
Surgical Intensive Care Unit, Clinical Center of Serbia, Institut of Neurosurgery
Belgrade
Surgical Intensive Care Unit, Clinical Center of Serbia
Belgrade
Switzerland1 site
Surgical and Medical Intensive Care Units, University Hospital Lausanne
Lausanne, Canton of Vaud
About this study
Official title: Proof of Concept Study to Investigate the Impact of Azithromycin Administered iv Versus Placebo on the Prevention of Pneumonia in Ventilated Patients Colonized by Pseudomonas Aeruginosa
The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.
- Being tested
- azithromycin, placebo
- Keywords
- Pseudomonas aeruginosa, Pneumonia, Ventilator-Associated, Quorum Sensing
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pseudomonas Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycinDrug
Also called Zithromax
300 mg/day, IV from day 1 to 20
placeboDrug
once per day, IV from day 1 to 20
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | azithromycin iv 300 mg/day Receives: Drug: azithromycin |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of and time to Pseudomonas aeruginosa pneumonia
Measured: daily
Secondary outcomes (9)
occurrence of and time to death
Measured: daily
time to extubation
Measured: daily
overall outcome
Measured: daily
duration of hospitalization and ICU stay
Measured: daily
occurrence of infections to other bacterial strains
Measured: daily
cost assessment
Measured: daily
demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa
Measured: daily
determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics
Measured: daily
determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startApr 2003
- Primary completionOct 2005
- Study completionOct 2005
Why it stopped: The sponsor decided to stop the study prematurely because of financial issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anbics Management-Services Ag
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Swiss National Science Foundation
- Investigators
- Christian Van Delden, MD, Principal investigator, Service of Infectious Diseases, University Hospital Geneva, SwitzerlandJean Carlet, MD, Study chair, General Intensive Care Unit, Hospital Saint-Joseph, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610623
- Sponsor's protocol ID
- Anb006#2001
- Status last verified
- Jan 2008
- First submitted
- 24 Jan 2008
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kohler T, Perron GG, Buckling A, van Delden C. Quorum sensing inhibition selects for virulence and cooperation in Pseudomonas aeruginosa. PLoS Pathog. 2010 May 6;6(5):e1000883. doi: 10.1371/journal.ppat.1000883.
PubMed 20463812
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study to Investigate the Impact of Azithromycin Administered iv Versus Placebo on the Prevention of Pneumonia in Ventilated Patients Colonized by Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT00610623
- Acronym / sponsor ID
- Anb006#2001
- Keywords
- Pseudomonas aeruginosa, Pneumonia, Ventilator-Associated, Quorum Sensing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to stop the study prematurely because of financial issues
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Anbics Management-Services AgIndustry (pharma, biotech, devices)
- Collaborators
- Swiss National Science Foundation
- Study start
- Apr 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 8 Feb 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 assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: azithromycinazithromycin iv 300 mg/day |
| 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and non pregnant female aged 18 to 75 years
- Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more
- Reasonable survival chance within next few days with an Apache score 10-25
- Tracheal aspirate found positive for P. aeruginosa
- The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent
Key exclusion criteria (13 listed)
- Poor prognosis as judged by Apache score II score >25
- Pregnant female
- Grossly under-or overweight (BMI<18or >29)
- Ongoing therapy with a macrolide
- Known allergy to any macrolide
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 |
|---|---|---|
| azithromycinAlso: Zithromax300 mg/day, IV from day 1 to 20 | Drug | 1 |
| placeboonce per day, IV from day 1 to 20 | Drug | 2 |
Primary outcome
Occurrence of and time to Pseudomonas aeruginosa pneumonia
Time frame: daily
9 secondary outcomes
occurrence of and time to death
Time frame: daily
time to extubation
Time frame: daily
overall outcome
Time frame: daily
duration of hospitalization and ICU stay
Time frame: daily
occurrence of infections to other bacterial strains
Time frame: daily
cost assessment
Time frame: daily
demonstrate using in vitro and in vivo parameters that azithromycin can be used as a quorum-sensing blocker against P. aeruginosa
Time frame: daily
determine whether prolonged treatment with azithromycin may induce resistance to any of 11 anti-pseudomonal antibiotics
Time frame: daily
determine whether P. aeruginosa can develop resistance to the quorum-sensing effect of azithromycin
Time frame: daily
Results and safety
The study was stopped early (reason given: The sponsor decided to stop the study prematurely because of financial issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2008.
- Derived from this study: PubMed 20463812Kohler T, Perron GG, Buckling A, van Delden C. Quorum sensing inhibition selects for virulence and cooperation in Pseudomonas aeruginosa. PLoS Pathog. 2010 May 6;6(5):e1000883. doi: 10.1371/journal.ppat.1000883.
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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.
Christian Van Delden, MD principal investigator
Service of Infectious Diseases, University Hospital Geneva, Switzerland
Jean Carlet, MD study chair
General Intensive Care Unit, Hospital Saint-Joseph, Paris, France
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing azithromycin in people with Pneumonia, Ventilator-Associated and Pseudomonas Infections, run by Anbics Management-Services Ag at 20 sites in 6 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Spain, Poland, Belgium, Serbia and Montenegro and 1 more country. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The sponsor decided to stop the study prematurely because of financial issues). Results are not available in the source record.
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?
Occurrence of and time to Pseudomonas aeruginosa pneumonia (time frame: daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00610623, which also lists 1 linked publication.
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 8 Feb 2008.