Wound InfectionsPhase 4PSWNCT00651131
Cubicin(R) for Complicated Post-surgical Wound Infections
A Phase 4 study testing daptomycin in people with Wound Infections, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
Trial summary
The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infections
- What is being tested?
- daptomycin
- Type of treatment
- Injection or infusion
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2004to 1 Mar 2005
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Read and signed informed consent form
- female of childbearing potential, negative pregnancy test result
- Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication
- Onset of surgical wound infection within 30 days after surgery
- At least three clinical signs and symptoms of skin infection
Who cannot join
- previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug
- Uncomplicated surgical infections (eg, stitch abscesses)
- osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
- Any type of space infection
- Conditions requiring surgical removal of wound infection
- necrotizing fasciitis, synergistic gangrene, Clostridial myonecrosis (gas gangrene), or Fournier's gangrene;
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- Foreign material involved in the post-surgical wound infection
- Known to be allergic or intolerant to study medication
- Creatinine Clearance (CLCR) <30 mL/min
- history of neurological disease (eg, Guillain-Barré, multiple sclerosis)
About this study
The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections
Read the detailed description
A multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections. Adjunctive treatment with aztreonam and/or metronidazole could be given for Gram-negative and/or anaerobic organisms. Patients are to be treated for a period of 7-14 days as specified in the package insert. An evaluation is to be performed on the day CUBICIN treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). A follow-up is required for patients with an Investigator response of 'Improved' at the end of treatment.
- Conditions
- Wound Infections
- Being tested
- daptomycin
- Keywords
- post-surgical, wound infection, superficial, deep, surgical
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daptomycinDrug
Also called Cubicin, daptomycin for injection, Cubicin (daptomycin for injection)
daptomycin i.v. 4 mg/kg q24h for 7-14 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's assessment of clinical response based on improvement of signs and symptoms
Measured: End of Therapy
Secondary outcomes (3)
Incidence of adverse events
Measured: first dose to end of therapy
eradication of pathogens isolated at admission
Measured: End of Therapy
overall therapeutic outcome based on agreement between clinical efficacy and microbiological response
Measured: End of Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study start1 Jun 2004
- Primary completion1 Mar 2005
- Study completion1 Mar 2005
Why it stopped: terminated due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651131
- Sponsor's protocol ID
- 3009-011
- Other IDs
- DAP-4PSW-03-03
- Acronym
- PSW
- Status last verified
- Aug 2017
- First submitted
- 31 Mar 2008
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cubicin(R) for Complicated Post-surgical Wound Infections
- ClinicalTrials.gov ID
- NCT00651131
- Acronym / sponsor ID
- PSW / 3009-011
- Conditions
- Wound Infections
- Keywords
- post-surgical, wound infection, superficial, deep, surgical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to slow enrollment
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2004 (actual)
- Primary completion
- 1 Mar 2005 (actual)
- Study completion
- 1 Mar 2005 (actual)
- First posted
- 2 Apr 2008 (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 the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections
Detailed description
A multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections. Adjunctive treatment with aztreonam and/or metronidazole could be given for Gram-negative and/or anaerobic organisms. Patients are to be treated for a period of 7-14 days as specified in the package insert. An evaluation is to be performed on the day CUBICIN treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). A follow-up is required for patients with an Investigator response of 'Improved' at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Read and signed informed consent form
- female of childbearing potential, negative pregnancy test result
- Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication
- Onset of surgical wound infection within 30 days after surgery
- At least three clinical signs and symptoms of skin infection
Key exclusion criteria (10 listed)
- previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug
- Uncomplicated surgical infections (eg, stitch abscesses)
- osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
- Any type of space infection
- Conditions requiring surgical removal of wound infection
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 |
|---|---|---|
| daptomycinAlso: Cubicin, daptomycin for injection, Cubicin (daptomycin for injection)daptomycin i.v. 4 mg/kg q24h for 7-14 days | Drug | – |
Primary outcome
Investigator's assessment of clinical response based on improvement of signs and symptoms
Time frame: End of Therapy
3 secondary outcomes
Incidence of adverse events
Time frame: first dose to end of therapy
eradication of pathogens isolated at admission
Time frame: End of Therapy
overall therapeutic outcome based on agreement between clinical efficacy and microbiological response
Time frame: End of Therapy
Results and safety
The study was stopped early (reason given: terminated due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing daptomycin in people with Wound Infections, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: terminated due to slow enrollment). Results are not available in the source record.
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?
Investigator's assessment of clinical response based on improvement of signs and symptoms (time frame: End of Therapy). 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 30 Aug 2017.