Skin DiseasesPhase 3NCT00772447

China Registration Study in Patients With Skin Infections

A Phase 3 study testing Daptomycin and Vancomycin in people with Skin Diseases and Infectious, run by AstraZeneca at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated Bacterial Skin and Skin Structure Infection due to… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Skin Diseases, Infectious
What is being tested?: Daptomycin and Vancomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 265 participants
Where: 13 sitesChina
Study dates: Sep 2008to Sep 2010
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of inform consent
A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria
Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing

Who cannot join

Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study
Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,
Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)
Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

China13 sites

Research Site
Beijing, Beijing Municipality
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Chongqing
Research Site
Dalian
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou
Research Site
Nanjing, Jiangsu
Research Site
Qingdao
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Suzhou, Jiangsu
Research Site
Wuhan, Hubei

Other trials in China

About this study

Official title: A Phase 3, Multicentre, Randomised, Investigator-blinded, Parallel-groupStudy of the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared With That of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects With cSSSI

Conditions: Skin Diseases, Infectious
Being tested: Daptomycin, Vancomycin
Keywords: Skin Infections, Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens
Medical subject headings: Skin Diseases, Communicable Diseases, Cellulitis

What participants receive

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

DaptomycinDrug
Also called Cubicin®
4mg/kg IV ; Q 24 hr (once every 24 hours)
VancomycinDrug
Vancomycin - 1g per 12 hrs, for 7-14 days
Or switch to
Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin:
- 1 g every 6 hours or 2 g every 8 hours

Study groups in NCT00772447
Study group	Role	What they receive
AZ drug	Experimental	Daptomycin Receives: Drug: Daptomycin
Comparator	Active comparator	Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin Receives: Drug: Vancomycin

What is being measured

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

Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood
Measured: baseline to TOC(test of cure), for up to 4 weeks
Change in Creatinine Clearance
Measured: baseline to TOC(test of cure), for up to 4 weeks
Change in Serum Total Creatine Phosphokinase (CPK)
Measured: baseline to TOC(test of cure), for up to 4 weeks
Change in Urine pH
Measured: baseline to TOC(test of cure), for up to 4 weeks
Shift in ECG
percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline
Measured: baseline to TOC(test of cure), for up to 4 weeks

Secondary outcomes (7)

Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)
The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)
Measured: baseline and TOC, for up to 4 weeks
Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)
The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)
Measured: baseline and EOT(end of therapy), for up to 2 weeks
Microbiological Response at TOC(Test of Cure)
The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline.
Measured: baseline and TOC, for up to 4 weeks
Microbiological Response at EOT(End of Therapy)
The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline.
Measured: baseline and EOT, for up to 2 weeks
Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)
This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups.
Measured: baseline and TOC, for up to 4 weeks
Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC
This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups.
Measured: baseline and TOC(test of cure), for up to 4 weeks
Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC
This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups.
Measured: baseline and TOC(test of cure), for up to 4 weeks

Timeline

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

Sep 2008Sep 2010

First posted15 Oct 2008 (estimated)
Study startSep 2008
Primary completionSep 2010
Study completionSep 2010

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 Skin DiseasesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Single blind
Who is masked: Investigator
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772447
Sponsor's protocol ID: D1790C00003
Status last verified: Feb 2015
First submitted: 9 Oct 2008
Last updated: 9 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicentre, Randomised, Investigator-blinded, Parallel-groupStudy of the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared With That of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects With cSSSI
ClinicalTrials.gov ID: NCT00772447
Acronym / sponsor ID: D1790C00003
Conditions: Skin Diseases, Infectious
Keywords: Skin Infections, Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 9 Mar 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
AZ drug	Experimental	Drug: DaptomycinDaptomycin
Comparator	Active comparator	Drug: VancomycinVancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Provision of inform consent
A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria
Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing

Key exclusion criteria (4 listed)

Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study
Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,
Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)
Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)

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®4mg/kg IV ; Q 24 hr (once every 24 hours)	Drug	AZ drug
VancomycinVancomycin - 1g per 12 hrs, for 7-14 days Or switch to Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin: - 1 g every 6 hours or 2 g every 8 hours	Drug	Comparator

Primary outcome

Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood
Change in Creatinine Clearance
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Change in Serum Total Creatine Phosphokinase (CPK)
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Change in Urine pH
Time frame: baseline to TOC(test of cure), for up to 4 weeks
Shift in ECG
Time frame: baseline to TOC(test of cure), for up to 4 weeks
percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline

7 secondary outcomes

Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)
Time frame: baseline and TOC, for up to 4 weeks
Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)
Time frame: baseline and EOT(end of therapy), for up to 2 weeks
Microbiological Response at TOC(Test of Cure)
Time frame: baseline and TOC, for up to 4 weeks
Microbiological Response at EOT(End of Therapy)
Time frame: baseline and EOT, for up to 2 weeks
Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)
Time frame: baseline and TOC, for up to 4 weeks
Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC
Time frame: baseline and TOC(test of cure), for up to 4 weeks
Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC
Time frame: baseline and TOC(test of cure), for up to 4 weeks

Results and safety

Results posted to the registry on 9 Mar 2015, 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	131	111
Vancomycin, or Vancomycin Switch to Cloxacillin	134	110

Primary outcome: Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)

Time frame: baseline to TOC(test of cure), for up to 4 weeks. Mean (Standard Deviation). Unit: percentage

Measure	Daptomycin n = 88	Vancomycin, or Vancomycin Switch to Cloxacillin n = 94
Value	0.00 (0.080)	0.01 (0.033)

Population analysed: Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline

Primary outcome: Change in Creatinine Clearance

Time frame: baseline to TOC(test of cure), for up to 4 weeks. Mean (Standard Deviation). Unit: ml/min

Measure	Daptomycin n = 80	Vancomycin, or Vancomycin Switch to Cloxacillin n = 79
Value	9.91 (76.851)	0.99 (21.232)

Population analysed: Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline

Primary outcome: Change in Serum Total Creatine Phosphokinase (CPK)

Time frame: baseline to TOC(test of cure), for up to 4 weeks. Mean (Standard Deviation). Unit: IU/L

Measure	Daptomycin n = 77	Vancomycin, or Vancomycin Switch to Cloxacillin n = 83
Value	0.60 (56.89)	-2.40 (46.05)

Population analysed: Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline

Primary outcome: Change in Urine pH

Time frame: baseline to TOC(test of cure), for up to 4 weeks. Mean (Standard Deviation). Unit: pH

Measure	Daptomycin n = 70	Vancomycin, or Vancomycin Switch to Cloxacillin n = 79
Value	-0.19 (0.960)	-0.30 (0.952)

Population analysed: Only patients who had measurements were included in the summary of a specific parameter at a specific time point. Change = TOC visit - baseline

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daptomycin	1 of ?	30 of ?	Not reported
Vancomycin, or Vancomycin Switch to Cloxacillin	3 of ?	39 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
CSR-D1790C00003.pdfLink provided by the sponsor.

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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.

Karen Atkin study director

AstraZeneca

Zhang Yingyuan, Prof. principal investigator

Antibiotics Institute, Huashan Hospital Affilicated to Fudan University

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daptomycin and Vancomycin in people with Skin Diseases and Infectious, run by AstraZeneca at 13 sites in China.

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 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. 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 9 Mar 2015). 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?

Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood) (time frame: baseline to TOC(test of cure), for up to 4 weeks). The study lists 5 primary outcomes in all. 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 NCT00772447.

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 9 Mar 2015.