Bacterial PneumoniaPhase 3ATTAIN2NCT00124020
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
A Phase 3 study testing Telavancin and Vancomycin in people with Bacterial Pneumonia, run by Cumberland Pharmaceuticals at 1 site in Israel.
Trial summary
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Pneumonia
- What is being tested?
- Telavancin and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 771 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2005to May 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.
Who cannot join
- Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
- Conditions
- Bacterial Pneumonia
- Being tested
- Telavancin, Vancomycin
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelavancinDrug
Also called TD6424, VIBATIV
Telavancin 10 mg/kg/day IV for up to 21 days
VancomycinDrug
Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days
| Study group | Role | What they receive |
|---|---|---|
| Telavancin | Experimental | Not described Receives: Drug: Telavancin |
| Vancomycin | Active comparator | Not described Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Clinical Response: Categorical (Cured, Failed or Indeterminate)
- Failure - at least one of the following:
- Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy
- Termination of study med due to "lack of efficacy"
- Death on or after Day 3 attributable to primary infection
- Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.
- Indeterminate: Inability to determine outcome
Measured: 7-14 days following end of antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startJan 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bacterial 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
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- G. Ralph Corey, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124020
- Sponsor's protocol ID
- 0019
- Acronym
- ATTAIN2
- Status last verified
- Dec 2018
- First submitted
- 22 Jul 2005
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McKinnell JA, Corman S, Patel D, Leung GH, Gordon LM, Lodise TP. Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus. Clin Ther. 2018 Mar;40(3):406-414.e2. doi: 10.1016/j.clinthera.2018.01.010. Epub 2018 Feb 15.
PubMed 29454592Smart JI, Corey GR, Stryjewski ME, Wang W, Barriere SL. Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates. Infect Dis Ther. 2016 Dec;5(4):535-544. doi: 10.1007/s40121-016-0133-y. Epub 2016 Oct 7.
PubMed 27718118Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.
PubMed 24708675
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT00124020
- Acronym / sponsor ID
- ATTAIN2 / 0019
- Conditions
- Bacterial Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 26 Jul 2005 (estimated)
- Results
- Posted 1 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telavancin | Experimental | Drug: Telavancin |
| Vancomycin | Active comparator | Drug: Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.
Key exclusion criteria (1 listed)
- Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
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 |
|---|---|---|
| TelavancinAlso: TD6424, VIBATIVTelavancin 10 mg/kg/day IV for up to 21 days | Drug | Telavancin |
| VancomycinVancomycin 1 Gm administered every 12 hrs IV for up to 21 days | Drug | Vancomycin |
Primary outcome
Clinical Response
Time frame: 7-14 days following end of antibiotic treatment
Clinical Response: Categorical (Cured, Failed or Indeterminate) * Failure - at least one of the following: * Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy * Termination of study med due to "lack of efficacy" * Death on or after Day 3 attributable to primary infection * Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. * Indeterminate: Inability to determine outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29454592McKinnell JA, Corman S, Patel D, Leung GH, Gordon LM, Lodise TP. Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus. Clin Ther. 2018 Mar;40(3):406-414.e2. doi: 10.1016/j.clinthera.2018.01.010. Epub 2018 Feb 15.
- Derived from this study: PubMed 27718118Smart JI, Corey GR, Stryjewski ME, Wang W, Barriere SL. Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates. Infect Dis Ther. 2016 Dec;5(4):535-544. doi: 10.1007/s40121-016-0133-y. Epub 2016 Oct 7.
- Derived from this study: PubMed 24708675Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.
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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.
G. Ralph Corey, MD principal investigator
Duke University
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 Telavancin and Vancomycin in people with Bacterial Pneumonia, run by Cumberland Pharmaceuticals at 1 site in Israel.
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 1 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 16 Jan 2019. 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 Israel. 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?
Yes. Results are posted in the registry (first posted 1 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Response (time frame: 7-14 days following end of antibiotic treatment). 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 NCT00124020, which also lists 3 linked publications.
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 16 Jan 2019.