Infections, Gram-positive BacterialPhase 2FAST2NCT00077675

Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

A Phase 2 study testing Telavancin and vancomycin or antistaphylococcal penicillin in people with Infections, Gram-positive Bacterial, run by Cumberland Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Infections, Gram-positive Bacterial
What is being tested?: Telavancin and vancomycin or antistaphylococcal penicillin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: 1 siteUnited States
Study dates: Feb 2004to Sep 2004
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

Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism
major abscess requiring surgical incision and drainage
infected burn (see exclusion criteria for important qualifications)
deep/extensive cellulitis
infected ulcer (see exclusion criteria for important qualifications)
wound infection
Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment

Who cannot join

Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)
Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis

Trial locations and contacts

1 site in 1 country.

United States1 site

Paradise Valley Hospital, 2400 E. 4th Street
National City, California, 91950

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Conditions: Infections, Gram-positive Bacterial
Being tested: Telavancin, vancomycin or antistaphylococcal penicillin
Keywords: Abscess, Burns, Cellulitis, Ulcer, Wound infections
Medical subject headings: Gram-Positive Bacterial Infections, Abscess, Burns, Cellulitis, Ulcer, Wound Infection

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 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
vancomycin or antistaphylococcal penicillinDrug
Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.

Study groups in NCT00077675
Study group	Role	What they receive
Telavancin	Experimental	Not described Receives: Drug: Telavancin
Standard of care for cSSSI	Active comparator	cSSSI - comlicated skin and skin structure infections Receives: Drug: vancomycin or antistaphylococcal penicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
- Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.
- Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit
- Indeterminate: Inability to determine outcome.
Measured: 7 to 14 days following completion of antibiotic treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2004Sep 2004

First posted13 Feb 2004 (estimated)
Study startFeb 2004
Primary completionSep 2004
Study completionSep 2004

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.
Other trials for Infections, Gram-positive BacterialStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00077675
Sponsor's protocol ID: I6424-202b
Acronym: FAST2
Status last verified: Jan 2019
First submitted: 10 Feb 2004
Last updated: 16 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Infections, Gram-positive Bacterial trials

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, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
ClinicalTrials.gov ID: NCT00077675
Acronym / sponsor ID: FAST2 / I6424-202b
Conditions: Infections, Gram-positive Bacterial
Keywords: Abscess, Burns, Cellulitis, Ulcer, Wound infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Sep 2004 (actual)
Study completion: Sep 2004 (actual)
First posted: 13 Feb 2004 (estimated)
Results: Posted 11 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Telavancin	Experimental	Drug: Telavancin
Standard of care for cSSSI	Active comparator	Drug: vancomycin or antistaphylococcal penicillincSSSI - comlicated skin and skin structure infections

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism
Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment

Key exclusion criteria (2 listed)

Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)
Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis

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 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days	Drug	Telavancin
vancomycin or antistaphylococcal penicillinVancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.	Drug	Standard of care for cSSSI

Primary outcome

Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
Time frame: 7 to 14 days following completion of antibiotic treatment
* Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. * Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit * Indeterminate: Inability to determine outcome.

Results and safety

Results posted to the registry on 11 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telavancin	103	92
Standard of Care for cSSSI	98	89

Primary outcome: Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population

Time frame: 7 to 14 days following completion of antibiotic treatment. Number. Unit: participants

Measure	Telavancin n = 77	Standard of Care for cSSSI n = 77
Cured	74	72
Failure	3	5

Telavancin vs Standard of Care for cSSSI: p = 0.5318, 2-sided 95% confidence interval calculat

Population analysed: The CE population was a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure." The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telavancin	7 of 100 (7%)	56 of 100 (56%)	Not reported
Standard of Care for cSSSI	3 of 95 (3.2%)	54 of 95 (56.8%)	Not reported

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.

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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 or antistaphylococcal penicillin in people with Infections, Gram-positive Bacterial, 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 7 inclusion and 2 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 11 Jan 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 Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population (time frame: 7 to 14 days following completion 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 NCT00077675.

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.