InfectionsPhase 3NCT01184872
Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections
A Phase 3 study testing Daptomycin and Vancomycin or Semi-Synthetic Penicillins (SSPs) in people with Infections, run by Novartis Pharmaceuticals at 17 sites in 5 countries.
Trial summary
The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Daptomycin and Vancomycin or Semi-Synthetic Penicillins (SSPs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Mar 2010to Mar 2011
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 65 years or older with infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours.
- Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections (cSSTIs) with or without bacteremia:
- Wound infections,
- Major abscesses with or without recognized preceding trauma, that require antibiotic therapy in addition to surgical incision and drainage,
- Severe carbunculosis,
- Infected ulcers (except patients with multiple infected ulcers) associated with: diabetes, vascular insufficiency, pressure (i.e., decubitus ulcers).
Who cannot join
- Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (e.g., amputation).
- Minor or superficial skin infections (e.g., furuncles, simple abscesses, acne, impetigo).
- Cellulitis, including erysipelas, not associated with complicating factors. However, patients with cellulitis associated with more serious infection (e.g., surgical wound, diabetic ulcer, deep tissue) can be enrolled (proportion of these patients will be limited to 30%).
- Infections for which outcome is difficult to assess:
- Perirectal abscess,
- Hidradenitis suppurativa,
Show all 22Show fewer
- Gangrene,
- Infected human or animal bites,
- Multiple infected ulcers at distant sites,
- Infected burns (only third degree burn wound or wound area of more than 10 cm diameter),
- Conditions requiring emergency surgery including necrotizing fasciitis.
- Medical conditions:
- History of significant allergy or intolerance to Vancomycin or Daptomycin. Hypersensitivity to SSPs penicillins is not an exclusion criterion,
- Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluation in this protocol,
- Infections associated with a permanent prosthetic device that will not be removed within 24 hours after enrolment,
- Known or suspected HIV infection with a CD4+ T-cell count < 500/μL (HIV testing is not required),
- Severe hepatic disease (Child-Pugh Class C) or ALT and/or AST > 5 times ULN and/ or total bilirubin > 2 times ULN at screening,
- Calculated creatinine clearance by the Cockcroft-Gault equation using actual body weight < 30 mL/min or any type of dialysis,
- Treatment with any investigational agent or device within 30 days of study drug administration.
- Previous systemic antibacterial therapy for the treatment of Gram-positive complicated skin and soft tissue infections for more than 24 hours within 48 hours prior to the day of first infusion of study drug unless:
- The previous antibacterial therapy was administered for 3 or more calendar days with either worsening or no improvement in the clinical signs and symptoms of cSSTIs, and was not Vancomycin or SSPs.
- Other protocol-defined inclusion/exclusion criteria applied.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Germany7 sites
Novartis Investigative Site
Bochum
Novartis Investigative Site
Essen
Novartis Investigative Site
Homburg
Novartis Investigative Site
Magdeburg
Novartis Investigative Site
Mannheim
Novartis Investigative Site
Münster
Novartis Investigative Site
Tübingen
Russia4 sites
Novartis Investigative Site (1)
Moscow
Novartis Investigative Site
Novosibirsk
Novartis Investigative Site (2)
Saint Petersburg
Novartis Investigative Site
Yaroslavi
Spain3 sites
Novartis Investigative Site (1)
Madrid
Novartis Investigative Site
Santander
Novartis Investigative Site
Seville
Austria2 sites
Novartis Investigative Site
Graz
Novartis Investigative Site
Vienna
About this study
Official title: An Open Label, Multi-center, Randomized, Comparative Phase IIIb Study to Compare Efficacy and Safety of Intravenous (i.v.) Daptomycin With That of Semi-Synthetic Penicillins (SSPs) or Vancomycin in the Treatment of Elderly Patients (Aged ≥ 65 Years) With Complicated Skin and Soft Tissue Infections (cSSTI)
The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.
- Conditions
- Infections
- Being tested
- Daptomycin, Vancomycin or Semi-Synthetic Penicillins (SSPs)
- Keywords
- Skin infection, Daptomycin, Elderly, Gram positive, Complicated skin and soft tissue infections
- Medical subject headings
- Infections, Cellulitis, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.
Vancomycin or Semi-Synthetic Penicillins (SSPs)Drug
Also called Oxacillin,, Cloxacillin,, Flucloxacillin,
Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. Receives: Drug: Daptomycin |
| Vancomycin or Semi-Synthetic Penicillins (SSPs) | Active comparator | Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days. Receives: Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.
Measured: Baseline and 7 to 14 days after end of therapy
Secondary outcomes (4)
Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation.
Measured: Baseline and 7 to 14 days after end of therapy
Duration of Treatment (Intravenous)
Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.
Measured: Up to 28 days
Duration of Treatment (Intravenous and Oral)
Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.
Measured: Up to 28 days
Number of Patients With Adverse Events, Serious Adverse Events and Death
Measured: Continuously from baseline up to 28 days after end of antibiotic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
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 InfectionsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmceuticals, Study director, Novartis Pharmceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184872
- Sponsor's protocol ID
- CCBC134A2404
- Other IDs
- 2009-014391-22, 2009
- Status last verified
- Jul 2012
- First submitted
- 18 Feb 2010
- Last updated
- 13 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI; Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis. 2004 Jun 15;38(12):1673-81. doi: 10.1086/420818. Epub 2004 May 20.
PubMed 15227611
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-center, Randomized, Comparative Phase IIIb Study to Compare Efficacy and Safety of Intravenous (i.v.) Daptomycin With That of Semi-Synthetic Penicillins (SSPs) or Vancomycin in the Treatment of Elderly Patients (Aged ≥ 65 Years) With Complicated Skin and Soft Tissue Infections (cSSTI)
- ClinicalTrials.gov ID
- NCT01184872
- Acronym / sponsor ID
- CCBC134A2404
- Conditions
- Infections
- Keywords
- Skin infection, Daptomycin, Elderly, Gram positive, Complicated skin and soft tissue infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Posted 18 Apr 2012
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 provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daptomycin | Experimental | Drug: DaptomycinPatients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. |
| Vancomycin or Semi-Synthetic Penicillins (SSPs) | Active comparator | Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs)Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days. Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients 65 years or older with infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours.
- Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections (cSSTIs) with or without bacteremia:
- Wound infections,
- Major abscesses with or without recognized preceding trauma, that require antibiotic therapy in addition to surgical incision and drainage,
- Severe carbunculosis,
Key exclusion criteria (22 listed)
- Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (e.g., amputation).
- Minor or superficial skin infections (e.g., furuncles, simple abscesses, acne, impetigo).
- Cellulitis, including erysipelas, not associated with complicating factors. However, patients with cellulitis associated with more serious infection (e.g., surgical wound, diabetic ulcer, deep tissue) can be enrolled (proportion of these patients will be limited to 30%).
- Perirectal abscess,
- Hidradenitis suppurativa,
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 |
|---|---|---|
| DaptomycinPatients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. | Drug | Daptomycin |
| Vancomycin or Semi-Synthetic Penicillins (SSPs)Also: Oxacillin,, Cloxacillin,, Flucloxacillin,Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days. Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days. | Drug | Vancomycin or Semi-Synthetic Penicillins (SSPs) |
Primary outcome
Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
Time frame: Baseline and 7 to 14 days after end of therapy
Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.
4 secondary outcomes
Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Time frame: Baseline and 7 to 14 days after end of therapy
Duration of Treatment (Intravenous)
Time frame: Up to 28 days
Duration of Treatment (Intravenous and Oral)
Time frame: Up to 28 days
Number of Patients With Adverse Events, Serious Adverse Events and Death
Time frame: Continuously from baseline up to 28 days after end of antibiotic treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15227611Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI; Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis. 2004 Jun 15;38(12):1673-81. doi: 10.1086/420818. Epub 2004 May 20.
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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.
Novartis Pharmceuticals study director
Novartis Pharmceuticals
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daptomycin and Vancomycin or Semi-Synthetic Penicillins (SSPs) in people with Infections, run by Novartis Pharmaceuticals at 17 sites in 5 countries.
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 6 inclusion and 22 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 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Russia, Spain, Austria, Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Apr 2012). 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?
Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit (time frame: Baseline and 7 to 14 days after end of therapy). 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 NCT01184872, 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 13 Jul 2012; AzTrials last refreshed its copy on 6 Nov 2026.