Staphylococcal Skin InfectionPhase 2NCT00442832
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection
A Phase 2 study testing TD-1792 and Vancomycin in people with Staphylococcal Skin Infection, run by Theravance Biopharma at 1 site in United States.
Trial summary
The purpose of this study is to determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Staphylococcal Skin Infection
- What is being tested?
- TD-1792 and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to May 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections
- requires at least 7 days of intravenous antibiotic treatment
Who cannot join
- more than 24 hours of antibiotic therapy
- moderate or severe liver disease
- severely neutropenic
- baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Double Blind, Study of Intravenous TD 1792 Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections
The purpose of this study is to determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria.
Read the detailed description
TD-1792 is compared to vancomycin for the treatment of cSSSI.
- Conditions
- Staphylococcal Skin Infection
- Being tested
- TD-1792, Vancomycin
- Keywords
- cSSSI, Staph, MRSA
- Medical subject headings
- Staphylococcal Skin Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-1792Drug
TD-1792 2 mg/kg/day IV
VancomycinDrug
Vancomycin 1 Gm IV q 12 hrs
| Study group | Role | What they receive |
|---|---|---|
| TD-1792 | Experimental | Not described Receives: Drug: TD-1792 |
| 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
Measured: 7 to 14 days after last antibiotic dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startDec 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal Skin InfectionStudies 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442832
- Sponsor's protocol ID
- 0041
- Status last verified
- Jan 2021
- First submitted
- 28 Feb 2007
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Study of Intravenous TD 1792 Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00442832
- Acronym / sponsor ID
- 0041
- Conditions
- Staphylococcal Skin Infection
- Keywords
- cSSSI, Staph, MRSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 2 Mar 2007 (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 determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria.
Detailed description
TD-1792 is compared to vancomycin for the treatment of cSSSI.
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 |
|---|---|---|
| TD-1792 | Experimental | Drug: TD-1792 |
| Vancomycin | Active comparator | Drug: Vancomycin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections
- requires at least 7 days of intravenous antibiotic treatment
Key exclusion criteria (4 listed)
- more than 24 hours of antibiotic therapy
- moderate or severe liver disease
- severely neutropenic
- baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy
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 |
|---|---|---|
| TD-1792TD-1792 2 mg/kg/day IV | Drug | TD-1792 |
| VancomycinVancomycin 1 Gm IV q 12 hrs | Drug | Vancomycin |
Primary outcome
Clinical response
Time frame: 7 to 14 days after last antibiotic dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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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.
Medical Monitor study director
Theravance Biopharma
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 TD-1792 and Vancomycin in people with Staphylococcal Skin Infection, run by Theravance Biopharma 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 2 inclusion and 4 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 20 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to 14 days after last antibiotic dose). 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 20 Jan 2021.