Staphylococcal Skin InfectionsPhase 4NCT00463801

Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections

A Phase 4 study testing Daptomycin in people with Staphylococcal Skin Infections, run by Novartis at 2 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Staphylococcal Skin Infections
What is being tested?: Daptomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 2 sitesItaly
Study dates: Jan 2007to Nov 2007
Phase: Phase 4
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

Subjects with a diagnosis of complicated skin and skin-structure infections (cSSTI) defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalization and intravenous antimicrobial treatment
Infection to be due to Gram-positive bacteria
Hospitalized subjects
Written informed consent
Female patients of childbearing potential must have a negative pregnancy test urine or serum at baseline and must use effective contraception throughout the study period.

Who cannot join

Complicated skin and skin-structure infections of the following categories:
Infected burns
Severely impaired arterial blood supply
Decubitus ulcers
Infected diabetic foot ulcers associated with osteomyelitis
Infected human or animal bites

Show all 26Show fewer

Perirectal abscess
Necrotising fasciitis or gangrene
Infections expected to require more than 14 days of intravenous antimicrobial therapy
Skin and/or skin structure infection that can be treated by surgery alone
Infections associated with a permanent prosthetic device that will not be removed within 2 days of study enrollment
Uncomplicated skin or soft tissue infection
Documented bacteremia at baseline
Concomitant infection nearby the site of infection at baseline, potentially interfering with the evaluations
Hospitalization for conditions related to rhabdomyolysis
Human immunodeficiency virus (HIV) with cluster of differentiation (CD) < 200 or < 14%
Immune function alterations
Lack of sufficient purulent material for culture and Gram test
Systemic or local antibiotic administration with known anti-Gram positive activity in the preceding 48 hours
Complicated skin and soft tissue infections (cSSTI) known or believed to be related to fungal, parasitic or viral infection
Pneumonia
Local or systemic known or suspected allergy to daptomycin
Creatinine clearance < 30 mL/min
Severe liver damage (Child-Pugh class C) or Alanine transaminase (ALT) and/or Aspartate aminotransferase (AST) > 3 x Upper limit of normal (ULN) and/or bilirubin > 1.5 x ULN
Use of any experimental drugs in the preceding 30 days
Severe medical conditions that in the investigator's opinion could counter indicate participation in the study

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

Novartis Italy
Novartis Italy
Novartis Italy
Saronno

Other trials in Italy

About this study

Official title: A Multicentre, Open Label, Uncontrolled Clinical Trial to Evaluate Efficacy and Safety of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections (cSSTI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)

This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults

Conditions: Staphylococcal Skin Infections
Being tested: Daptomycin
Keywords: Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis, Complicated skin and skin-structure infections
Medical subject headings: Staphylococcal Skin Infections, Diabetic Foot, Abscess, Cellulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaptomycinDrug

Study groups in NCT00463801
Study group	Role	What they receive
Daptomycin	Experimental	350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days. Receives: Drug: Daptomycin

What is being measured

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

Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start
Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.
Measured: at Day 7 and 14

Secondary outcomes (6)

Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria
To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.
Measured: At day 4, 7, 10 and 14
Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10
To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.
Measured: At day 4 and 10
Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous
Measured: At day 14
Efficacy Assessed by Time of Resolution of Infection
Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).
Measured: At day 14
Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE
Measured: At day 14
Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)
Measured: at day 14 and follow up day i.e. day 30

Timeline

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

Jan 2007Nov 2007

First posted20 Apr 2007 (estimated)
Study startJan 2007
Primary completionNov 2007

Why it stopped: Because of inadequate accrual.

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 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00463801
Sponsor's protocol ID: CCBC134AIT01
Status last verified: Mar 2011
First submitted: 19 Apr 2007
Last updated: 24 Mar 2011
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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All Staphylococcal Skin Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Open Label, Uncontrolled Clinical Trial to Evaluate Efficacy and Safety of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections (cSSTI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)
ClinicalTrials.gov ID: NCT00463801
Acronym / sponsor ID: CCBC134AIT01
Conditions: Staphylococcal Skin Infections
Keywords: Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis, Complicated skin and skin-structure infections
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Because of inadequate accrual.
Enrolment: 52 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Nov 2007 (actual)
First posted: 20 Apr 2007 (estimated)
Results: Posted 23 Dec 2010

Clinical summary

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

This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Daptomycin	Experimental	Drug: Daptomycin350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.

Who may qualify

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

Key inclusion criteria (5 listed)

Subjects with a diagnosis of complicated skin and skin-structure infections (cSSTI) defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalization and intravenous antimicrobial treatment
Infection to be due to Gram-positive bacteria
Hospitalized subjects
Written informed consent
Female patients of childbearing potential must have a negative pregnancy test urine or serum at baseline and must use effective contraception throughout the study period.

Key exclusion criteria (26 listed)

Complicated skin and skin-structure infections of the following categories:
Infected burns
Severely impaired arterial blood supply
Decubitus ulcers
Infected diabetic foot ulcers associated with osteomyelitis

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
Daptomycin	Drug	Daptomycin

Primary outcome

Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start
Time frame: at Day 7 and 14
Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.

6 secondary outcomes

Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria
Time frame: At day 4, 7, 10 and 14
Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10
Time frame: At day 4 and 10
Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous
Time frame: At day 14
Efficacy Assessed by Time of Resolution of Infection
Time frame: At day 14
Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE
Time frame: At day 14
Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)
Time frame: at day 14 and follow up day i.e. day 30

Results and safety

Results posted to the registry on 23 Dec 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
Daptomycin Intravenous	52	39

Primary outcome: Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start

Time frame: at Day 7 and 14. Number. Unit: Participants

Measure	Daptomycin Intravenous n = 52
Value	0

Population analysed: Intention to treat (ITT) and safety population: all patients who received at least one dose of study medication.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	4 of 52 (7.7%)	6 of 52 (11.5%)	Not reported

Limitations and caveats (from the sponsor): Inadequate accrual caused the premature study termination and the insufficient sample size, therefore none of the planned study analyses were performed; nor were any tabulations with descriptive statistics were provided.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Staphylococcal Skin Infections

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Recruiting
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Atopic Dermatitis
Not yet recruitingObservational study
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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 study director

Novartis

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Daptomycin in people with Staphylococcal Skin Infections, run by Novartis at 2 sites in Italy.

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 26 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 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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 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?

Yes. Results are posted in the registry (first posted 23 Dec 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?

Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start (time frame: at Day 7 and 14). 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 NCT00463801.

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 24 Mar 2011.