Gram-Positive Bacterial InfectionsPhase 2ASSURENCT00062647
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
A Phase 2 study testing Telavancin and Vancomycin, nafcillin, oxacillin, or cloxacillin in people with Gram-Positive Bacterial Infections, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-Positive Bacterial Infections
- What is being tested?
- Telavancin and Vancomycin, nafcillin, oxacillin, or cloxacillin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Aug 2006
- Phase
- Phase 2
- 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
- Documented S. aureus bacteremia
Who cannot join
- Patients who had received or would have received more than 72 hours of potentially effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellstar Infectious Disease
Marietta, Georgia, 30060
About this study
Official title: A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.
- Conditions
- Gram-Positive Bacterial Infections
- Being tested
- Telavancin, Vancomycin, nafcillin, oxacillin, or cloxacillin
- Medical subject headings
- Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelavancinDrug
Also called TD-6424, VIBATIV
Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
Vancomycin, nafcillin, oxacillin, or cloxacillinDrug
Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Telavancin | Experimental | Not described Receives: Drug: Telavancin |
| Vancomycin, nafcillin, oxacillin, or cloxacillin | Active comparator | Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously Receives: Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation
Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.
Measured: 12 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2003 (estimated)
- Study startAug 2003
- Primary completionAug 2006
- Study completionAug 2006
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 (1)Papers the sponsor has linked to this study.
- Other trials for Gram-Positive Bacterial InfectionsStudies 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
- 60 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
- NCT00062647
- Sponsor's protocol ID
- I6424-203a
- Acronym
- ASSURE
- Status last verified
- Jan 2019
- First submitted
- 9 Jun 2003
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stryjewski ME, Lentnek A, O'Riordan W, Pullman J, Tambyah PA, Miro JM, Fowler VG Jr, Barriere SL, Kitt MM, Corey GR. A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study. BMC Infect Dis. 2014 May 23;14:289. doi: 10.1186/1471-2334-14-289.
PubMed 24884578
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 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
- ClinicalTrials.gov ID
- NCT00062647
- Acronym / sponsor ID
- ASSURE / I6424-203a
- Conditions
- Gram-Positive Bacterial Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 Jun 2003 (estimated)
- Results
- Posted 22 Mar 2011
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 determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.
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, nafcillin, oxacillin, or cloxacillin | Active comparator | Drug: Vancomycin, nafcillin, oxacillin, or cloxacillinVancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented S. aureus bacteremia
Key exclusion criteria (1 listed)
- Patients who had received or would have received more than 72 hours of potentially effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid
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: TD-6424, VIBATIVTelavancin 10mg/kg/day IV every 24 hrs for up to 14 days | Drug | Telavancin |
| Vancomycin, nafcillin, oxacillin, or cloxacillinVancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days. | Drug | Vancomycin, nafcillin, oxacillin, or cloxacillin |
Primary outcome
Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation
Time frame: 12 weeks after start of treatment
Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.
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 24884578Stryjewski ME, Lentnek A, O'Riordan W, Pullman J, Tambyah PA, Miro JM, Fowler VG Jr, Barriere SL, Kitt MM, Corey GR. A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study. BMC Infect Dis. 2014 May 23;14:289. doi: 10.1186/1471-2334-14-289.
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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 2 study testing Telavancin and Vancomycin, nafcillin, oxacillin, or cloxacillin in people with Gram-Positive Bacterial Infections, run by Cumberland Pharmaceuticals 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 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 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 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?
Yes. Results are posted in the registry (first posted 22 Mar 2011). 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 (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation (time frame: 12 weeks after start of 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 NCT00062647, 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 16 Jan 2019.