Staphylococcal Skin InfectionsNCT00737269
A Complicated Skin and Soft-tissue Infection Patient Registry
An observational study of Staphylococcal Skin Infections and Diabetic Foot Infections, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
Trial summary
The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Skin Infections, Diabetic Foot Infections, Surgical Wound Infection
- How many people
- 1,081 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jan 2010
- Phase
- Observational
- 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
Study population: Patients with complicated skin and soft tissue infections (specifically, diabetic foot infections, surgical site infections, deep soft tissue abscess, cellulitis)
Who may be able to join
- Patients with a diagnosis of complicated skin and soft-tissue infection
- Patients who require IV antibiotic therapy as a primary treatment regimen
- Patients who are deemed to be cognitive and able to provide written informed consent and follow-up information.
Who cannot join
- Patients with a diagnosis at the index infection site of necrotizing soft tissue infection, burn, gangrene, decubitus ulcer, animal or human bites, known or suspected osteomyelitis, or mediastinitis
- Patients for whom amputation or a complete resection of the infection site is a planned component of treatment
- Patients who are pregnant
- Patients simultaneously participating in any interventional clinical trial
- Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements
- Patients who are employees of the investigator or study hospital
About this study
Official title: A Prospective, Multi-center, Observational Registry Involving Patients Hospitalized With Complicated Skin and Soft Tissue Infections (cSSTI) for IV Antibiotic Therapy
The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy.
Read the detailed description
A prospective, multi-center, observational study involving 1200 patients hospitalized for the treatment of cSSTIs. The study will be conducted at approximately 50 hospitals in the US. Patients who consent to participate in the registry will be enrolled in the registry within 24 hours of initial IV antibiotic therapy for treatment of one or more cSSTI types. Sites will treat patients according to their usual clinical practice. The objective of this registry is to characterize cSSTIs with respect to patient characteristics and describe patient outcomes.
- Conditions
- Staphylococcal Skin Infections, Diabetic Foot Infections, Surgical Wound Infection, Abscess, Cellulitis
- Keywords
- Complicated Skin and Soft-Tissue Infection, Skin Infection, Skin Infection Registry, cSSTI Registry
- Medical subject headings
- Staphylococcal Skin Infections, Surgical Wound Infection, Abscess, Cellulitis, Soft Tissue Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal Skin 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737269
- Sponsor's protocol ID
- CR015043
- Other IDs
- CEFTOSSK4001
- Status last verified
- Mar 2013
- First submitted
- 14 Aug 2008
- Last updated
- 4 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Observational Registry Involving Patients Hospitalized With Complicated Skin and Soft Tissue Infections (cSSTI) for IV Antibiotic Therapy
- ClinicalTrials.gov ID
- NCT00737269
- Acronym / sponsor ID
- CR015043
- Conditions
- Staphylococcal Skin Infections, Diabetic Foot Infections, Surgical Wound Infection, Abscess, Cellulitis
- Keywords
- Complicated Skin and Soft-Tissue Infection, Skin Infection, Skin Infection Registry, cSSTI Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,081 participants (actual)
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Aug 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 this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy.
Detailed description
A prospective, multi-center, observational study involving 1200 patients hospitalized for the treatment of cSSTIs. The study will be conducted at approximately 50 hospitals in the US. Patients who consent to participate in the registry will be enrolled in the registry within 24 hours of initial IV antibiotic therapy for treatment of one or more cSSTI types. Sites will treat patients according to their usual clinical practice. The objective of this registry is to characterize cSSTIs with respect to patient characteristics and describe patient outcomes.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with complicated skin and soft tissue infections (specifically, diabetic foot infections, surgical site infections, deep soft tissue abscess, cellulitis)
Key inclusion criteria (3 listed)
- Patients with a diagnosis of complicated skin and soft-tissue infection
- Patients who require IV antibiotic therapy as a primary treatment regimen
- Patients who are deemed to be cognitive and able to provide written informed consent and follow-up information.
Key exclusion criteria (6 listed)
- Patients with a diagnosis at the index infection site of necrotizing soft tissue infection, burn, gangrene, decubitus ulcer, animal or human bites, known or suspected osteomyelitis, or mediastinitis
- Patients for whom amputation or a complete resection of the infection site is a planned component of treatment
- Patients who are pregnant
- Patients simultaneously participating in any interventional clinical trial
- Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2013.
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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.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcal Skin Infections and Diabetic Foot Infections, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
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 3 inclusion and 6 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 4 Mar 2013. 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.
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.
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 4 Mar 2013.