Community Acquired PneumoniaPhase 3NCT02269644
A P3 Comparator Trial in Community Acquired Bacterial Pneumonia
A Phase 3 study testing Dalbavancin, Linezolid and Azithromycin in people with Community Acquired Pneumonia, run by Durata Therapeutics Inc., an affiliate of Allergan plc at 1 site in United States.
Trial summary
This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Dalbavancin, Linezolid and Azithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2016
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 85, inclusive
- Has given written, informed consent
- Has acute illness with onset within previous 7 days
- Has at least 2 of the following symptoms:
- Difficulty breathing or shortness of breath
- Cough
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- Production of purulent sputum
- Pleuritic chest pain
- Has at least 2 vital sign abnormalities:
- Fever (> 38°C or < 35°C)
- Hypotension (systolic BP < 90 mm Hg)
- Tachycardia (> 100 beats /min)
- Tachypnea (> 24 breaths /min)
- Has at least one other clinical or laboratory abnormalities:
- Hypoxemia (room air SaO2 < 90% )
- Clinical evidence of pulmonary consolidation
- Elevated WBC count or neutropenia (> 12,000/mm3 or < 4,000/mm3)
- Has new lobar or multi-lobar infiltrates on chest radiograph
- Has CURB-65 risk category 1 to 4. Patients with CURB-65 risk category 1 will be limited to 20% of the total patient population
Who cannot join
- Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1)
- Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life < 8 hours) antibiotic
- Has aspiration pneumonia
- Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days
- Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis
- Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant
Show all 20Show fewer
- Has primary or metastatic lung cancer
- Has known bronchial obstruction or a history of post-obstructive pneumonia
- Requires admission to ICU at baseline
- Has empyema requiring drainage
- Infection due to an organism known prior to study entry to be resistant to either treatment regimen
- Has known or suspected infection due solely to an atypical pathogen such as Mycoplasma sp., Chlamydia sp. or Legionella sp. or positive Legionella urinary antigen at baseline
- Absolute neutrophil count < 500 cells/mm3
- Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count
- Patients with a recent bone marrow transplant (in post-transplant hospital stay)
- Patients receiving oral steroids > 40 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation
- Patients with a rapidly fatal illness, who are not expected to survive for 3 months
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Has participated in another trial of an investigational pharmaceutical product in the 30 days prior to enrollment
- Prior participation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Double-blinded, Randomized, Comparator Trial of the Safety and Efficacy of a Single Dose of Dalbavancin to Twice Daily Linezolid for the Treatment of Community Acquired Bacterial Pneumonia
This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.
Read the detailed description
This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of CABP. Adult patients who meet all inclusion and none of the exclusion criteria will be randomized to one of the two treatment arms. Dosing will commence on Day 1, and all patients will receive a minimum of 10 days of therapy. Patients will be assessed on Day 1, Day 4-5, Day 7, Day 14 (End of Therapy, EOT), and Day 28 (Follow up).
- Conditions
- Community Acquired Pneumonia
- Being tested
- Dalbavancin, Linezolid, Linezolid Placebo, Azithromycin
- 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.
DalbavancinDrug
Also called Dalvance
dalbavancin 1500 mg IV over 30 minutes on Day 1
LinezolidDrug
Also called Zyvox
linezolid 600 mg every 12 hours for a minimum of 10 days and a maximum of 14 days
Linezolid PlaceboDrug
Dalbavancin randomized subjects after Day 1, 1st dose will receive linezolid placebo every 12 hours for a minimum of 10 days and a maximum of 14 days
AzithromycinDrug
Dalbavancin and linezolid randomized subjects on Day 1, 1st dose receive 500 mg of IV azithromycin
| Study group | Role | What they receive |
|---|---|---|
| Dalbavancin | Experimental | Dalbavancin randomized subjects will receive one dose of dalbavancin 1500 mg IV over 30 minutes on Day 1 plus azithromycin 500 mg IV on Day 1. Dalbavancin dose will be adjusted for subjects with significant renal insufficiency who are not receiving regular hemodialysis. All patients in the dalbavancin group will receive placebo linezolid infusions or tablets to maintain the blinding. Dalbavancin dose will be adjusted for subjects with significant renal insufficiency who are not receiving regular hemodialysis Receives: Drug: Dalbavancin |
| Linezolid | Active comparator | Linezolid randomized subjects will receive linezolid 600 mg every 12 hours for a minimum of 10 days, and a maximum of 14 days. All patients will receive at least one IV dose of linezolid initially plus azithromycin 500 mg IV only on Day 1. Subjects then may then be switched to oral linezolid at the discretion of the investigator, if clinical improvement in the signs and symptoms of pneumonia is observed, to complete the 10-14 day course of therapy,. No dose adjustment is required for renal insufficiency. Receives: Drug: Linezolid |
| Linezold Placebo IV and Oral Capsules | Other | Dalbavancin randomized subjects after the 1st dose on Day 1 will receive placebo linezolid every 12 hours for a minimum of 10 days and a maximum of 14 days. Dalbavancin randomized subjects may be switched to oral linezolid placebo therapy to complete the 10-14 day course of therapy. Receives: Drug: Linezolid Placebo |
| Azithromycin | Other | Dalbavancin and linezolid randomized subjects on Day 1, 1st dose will also receive 500 mg of IV azithromycin Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response of CABP Symptoms
Compare the efficacy of a single 1500 mg dose of intravenous dalbavancin plus azithromycin to the comparator regimen (linezolid plus azithromycin). Response will be based on resolution of symptoms; including chest pain, shortness of breath (difficulty breathing), frequency/severity of cough and amount of sputum production. Each of these symptoms will be assessed on a 4 point scale (absent, mild, moderate or severe). A patient will be defined as a clinical responder if there is at least a 1 point improvement in 2 or more of these symptoms at 72-120 hours after randomization compared to baseline.
Measured: Change from Baseline to 72-120 hours after randomization
Secondary outcomes (2)
Efficacy of dalbavancin to the comparator regimen
Test the efficacy of dalbavancin to the comparator regimen using alternative outcome measures including:1) improvement at Day 4-5 in at least two of the following symptoms with no worsening in any of these symptoms of CABP compared to baseline: chest pain, frequency or severity of cough, amount of productive sputum, and difficulty breathing and improvement in vital signs (i.e. temperature, heart rate, respiratory rate or blood pressure); 2) clinical outcome (using primary response criteria) at Day 14; 3) Investigator Assessment of Outcome at Day 14 and Day 28, with success defined as complete resolution of symptoms and signs attributable to CABP and did not receive non-trial antibacterial drugs for treatment of CABP.4) all-cause mortality at Day 28
Measured: Change from baseline to 72-120 hours after randomization, Day 14 and Day 28
Safety Analysis
To test the safety profile of dalbavancin 1500 mg versus comparator. Safety will be assessed by means of physical examination and vital signs, collection of adverse, events and clinical laboratory tests through out the study.
Measured: Safety will be assessed at all time-points through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Urania Rappo, MD, Study director, Durata Therapeutics Inc., an affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269644
- Sponsor's protocol ID
- DUR001-305
- Other IDs
- 2014-002683-32, 2014
- Status last verified
- Jan 2016
- First submitted
- 7 Oct 2014
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blinded, Randomized, Comparator Trial of the Safety and Efficacy of a Single Dose of Dalbavancin to Twice Daily Linezolid for the Treatment of Community Acquired Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT02269644
- Acronym / sponsor ID
- DUR001-305
- Conditions
- Community Acquired Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Oct 2014 (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.
This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.
Detailed description
This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of CABP. Adult patients who meet all inclusion and none of the exclusion criteria will be randomized to one of the two treatment arms. Dosing will commence on Day 1, and all patients will receive a minimum of 10 days of therapy. Patients will be assessed on Day 1, Day 4-5, Day 7, Day 14 (End of Therapy, EOT), and Day 28 (Follow up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dalbavancin | Experimental | Drug: DalbavancinDalbavancin randomized subjects will receive one dose of dalbavancin 1500 mg IV over 30 minutes on Day 1 plus azithromycin 500 mg IV on Day 1. Dalbavancin dose will be adjusted for subjects with significant renal insufficiency who are not receiving regular hemodialysis. All patients in the dalbavancin group will receive placebo linezolid infusions or tablets to maintain the blinding. Dalbavancin dose will be adjusted for subjects with significant renal insufficiency who are not receiving regular hemodialysis |
| Linezolid | Active comparator | Drug: LinezolidLinezolid randomized subjects will receive linezolid 600 mg every 12 hours for a minimum of 10 days, and a maximum of 14 days. All patients will receive at least one IV dose of linezolid initially plus azithromycin 500 mg IV only on Day 1. Subjects then may then be switched to oral linezolid at the discretion of the investigator, if clinical improvement in the signs and symptoms of pneumonia is observed, to complete the 10-14 day course of therapy,. No dose adjustment is required for renal insufficiency. |
| Linezold Placebo IV and Oral Capsules | Other | Drug: Linezolid PlaceboDalbavancin randomized subjects after the 1st dose on Day 1 will receive placebo linezolid every 12 hours for a minimum of 10 days and a maximum of 14 days. Dalbavancin randomized subjects may be switched to oral linezolid placebo therapy to complete the 10-14 day course of therapy. |
| Azithromycin | Other | Drug: AzithromycinDalbavancin and linezolid randomized subjects on Day 1, 1st dose will also receive 500 mg of IV azithromycin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adults aged 18 to 85, inclusive
- Has given written, informed consent
- Has acute illness with onset within previous 7 days
- Has at least 2 of the following symptoms:
- Has at least 2 vital sign abnormalities:
Key exclusion criteria (20 listed)
- Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1)
- Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life < 8 hours) antibiotic
- Has aspiration pneumonia
- Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days
- Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis
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 |
|---|---|---|
| DalbavancinAlso: Dalvancedalbavancin 1500 mg IV over 30 minutes on Day 1 | Drug | Dalbavancin |
| LinezolidAlso: Zyvoxlinezolid 600 mg every 12 hours for a minimum of 10 days and a maximum of 14 days | Drug | Linezolid |
| Linezolid PlaceboDalbavancin randomized subjects after Day 1, 1st dose will receive linezolid placebo every 12 hours for a minimum of 10 days and a maximum of 14 days | Drug | Linezold Placebo IV and Oral Capsules |
| AzithromycinDalbavancin and linezolid randomized subjects on Day 1, 1st dose receive 500 mg of IV azithromycin | Drug | Azithromycin |
Primary outcome
Treatment Response of CABP Symptoms
Time frame: Change from Baseline to 72-120 hours after randomization
Compare the efficacy of a single 1500 mg dose of intravenous dalbavancin plus azithromycin to the comparator regimen (linezolid plus azithromycin). Response will be based on resolution of symptoms; including chest pain, shortness of breath (difficulty breathing), frequency/severity of cough and amount of sputum production. Each of these symptoms will be assessed on a 4 point scale (absent, mild, moderate or severe). A patient will be defined as a clinical responder if there is at least a 1 point improvement in 2 or more of these symptoms at 72-120 hours after randomization compared to baseline.
2 secondary outcomes
Efficacy of dalbavancin to the comparator regimen
Time frame: Change from baseline to 72-120 hours after randomization, Day 14 and Day 28
Safety Analysis
Time frame: Safety will be assessed at all time-points through Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
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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.
Urania Rappo, MD study director
Durata Therapeutics Inc., an affiliate of Allergan plc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dalbavancin, Linezolid and Azithromycin in people with Community Acquired Pneumonia, run by Durata Therapeutics Inc., an affiliate of Allergan plc at 1 site in United States.
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 19 inclusion and 20 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: withdrawn, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Treatment Response of CABP Symptoms (time frame: Change from Baseline to 72-120 hours after randomization). 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 22 Jan 2016.