Staphylococcal InfectionPhase 3NCT00770341

A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)

A Phase 3 study testing Daptomycin 4 mg/kg, Comparator: vancomycin and Daptomycin 6 mg/kg in people with Staphylococcal Infection, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

Search all trials

Trial summary

The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA). Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Staphylococcal Infection
What is being tested?: Daptomycin 4 mg/kg, Comparator: vancomycin and Daptomycin 6 mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: No sites listed yet
Study dates: Sep 2008to Feb 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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Both Sexes, Aged 20 Years Or Older
Japanese Participants With Skin And Soft Tissue Infections, Septicemia, or RIE Known Or Suspected To Be Caused By MRSA
Written Informed Consent

Who cannot join

Participants With Skin and Soft Tissue infections That Can Be Treated By Surgery Alone
Participants With Pneumonia

About this study

Official title: A Phase III Randomized, Open-labeled Clinical Trial of MK-3009 (Daptomycin) in Patients With Skin and Soft Tissue Infections, Septicemia and Right-sided Infective Endocarditis Caused by MRSA

Conditions: Staphylococcal Infection
Being tested: Daptomycin 4 mg/kg, Comparator: vancomycin, Daptomycin 6 mg/kg
Medical subject headings: Staphylococcal Infections

What participants receive

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

Daptomycin 4 mg/kgDrug
Also called MK3009
MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)
Comparator: vancomycinDrug
vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days
Daptomycin 6 mg/kgDrug
MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis

Study groups in NCT00770341
Study group	Role	What they receive
MK-3009 (daptomycin) 4 mg/kg	Experimental	Not described Receives: Drug: Daptomycin 4 mg/kg
Vancomycin	Active comparator	Not described Receives: Drug: Comparator: vancomycin
MK-3009 (daptomycin) 6 mg/kg	Experimental	Not described Receives: Drug: Daptomycin 6 mg/kg

What is being measured

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

Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)
Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT).
MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline.
Measured: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)
Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC
Response = eradicated or presumed eradicated.
Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.
Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen.
Measured: 7-14 days for SSTI, 14-42 days for septicemia and RIE

Secondary outcomes (4)

EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).
Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.
Measured: 7-14 days for SSTI, 14-42 days for septicemia and RIE
EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).
Response = eradicated or presumed eradicated.
Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.
Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen.
Measured: 7-14 days for SSTI, 14-42 days for septicemia and RIE
Study Investigators' Assessment of Clinical Response at EOT
Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.
Measured: 7-14 days for SSTI, 14-42 days for septicemia and RIE
Study Investigators' Assessment of Clinical Response at TOC
Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.
Measured: 7-14 days for SSTI, 14-42 days for septicemia and RIE

Timeline

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

Sep 2008Feb 2010

First posted10 Oct 2008 (estimated)
Study startSep 2008
Primary completionFeb 2010
Study completionFeb 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Staphylococcal InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00770341
Sponsor's protocol ID: 3009-002
Other IDs: 2008_564
Status last verified: Feb 2017
First submitted: 9 Oct 2008
Last updated: 24 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Aikawa N, Kusachi S, Mikamo H, Takesue Y, Watanabe S, Tanaka Y, Morita A, Tsumori K, Kato Y, Yoshinari T. Efficacy and safety of intravenous daptomycin in Japanese patients with skin and soft tissue infections. J Infect Chemother. 2013 Jun;19(3):447-55. doi: 10.1007/s10156-012-0501-9. Epub 2012 Oct 20.
PubMed 23085743
Takesue Y, Mikamo H, Kusachi S, Watanabe S, Takahashi K, Yoshinari T, Ishii M, Aikawa N. Correlation between pharmacokinetic/pharmacodynamic indices and clinical outcomes in Japanese patients with skin and soft tissue infections treated with daptomycin: analysis of a phase III study. Diagn Microbiol Infect Dis. 2015 Sep;83(1):77-81. doi: 10.1016/j.diagmicrobio.2015.05.013. Epub 2015 May 28.
PubMed 26072149

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?

Official record

RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC

All Staphylococcal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Open-labeled Clinical Trial of MK-3009 (Daptomycin) in Patients With Skin and Soft Tissue Infections, Septicemia and Right-sided Infective Endocarditis Caused by MRSA
ClinicalTrials.gov ID: NCT00770341
Acronym / sponsor ID: 3009-002
Conditions: Staphylococcal Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 10 Oct 2008 (estimated)
Results: Posted 15 Jun 2011

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: None (open label)
Number of arms: 3

Arm	Type	Receives
MK-3009 (daptomycin) 4 mg/kg	Experimental	Drug: Daptomycin 4 mg/kg
Vancomycin	Active comparator	Drug: Comparator: vancomycin
MK-3009 (daptomycin) 6 mg/kg	Experimental	Drug: Daptomycin 6 mg/kg

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Both Sexes, Aged 20 Years Or Older
Japanese Participants With Skin And Soft Tissue Infections, Septicemia, or RIE Known Or Suspected To Be Caused By MRSA
Written Informed Consent

Key exclusion criteria (2 listed)

Participants With Skin and Soft Tissue infections That Can Be Treated By Surgery Alone
Participants With Pneumonia

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 4 mg/kgAlso: MK3009MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI)	Drug	MK-3009 (daptomycin) 4 mg/kg
Comparator: vancomycinvancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days	Drug	Vancomycin
Daptomycin 6 mg/kgMK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis	Drug	MK-3009 (daptomycin) 6 mg/kg

Primary outcome

Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)
Time frame: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)
Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT). MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline.
Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC
Time frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
Response = eradicated or presumed eradicated. Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen. Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen.

4 secondary outcomes

EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).
Time frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).
Time frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
Study Investigators' Assessment of Clinical Response at EOT
Time frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE
Study Investigators' Assessment of Clinical Response at TOC
Time frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE

Results and safety

Results posted to the registry on 15 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-3009 (Daptomycin) 4 mg/kg	89	77
Vancomycin	22	17
MK-3009 (Daptomycin) 6 mg/kg	11	8

Primary outcome: Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)

Time frame: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE). Number. Unit: Participants

Measure	MK-3009 (Daptomycin) 4 mg/kg n = 55	Vancomycin n = 19	MK-3009 (Daptomycin) 6 mg/kg n = 4
Value	45	16	2

Population analysed: MITT-MRSA; One participant with possible MRSA RIE was enrolled. This participant was excluded from the efficacy population.

Primary outcome: Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC

Time frame: 7-14 days for SSTI, 14-42 days for septicemia and RIE. Number. Unit: Participants

Measure	MK-3009 (Daptomycin) 4 mg/kg n = 55	Vancomycin n = 19	MK-3009 (Daptomycin) 6 mg/kg n = 4
Value	31	9	2

Population analysed: MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.

4 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
NOT TREATED	0 of 1 (0%)	0 of 1 (0%)	Not reported
DAPTOMYCIN (4 MG/KG)	6 of 88 (6.8%)	34 of 88 (38.6%)	Not reported
VANCOMYCIN	4 of 22 (18.2%)	11 of 22 (50%)	Not reported
DAPTOMYCIN (6 MG/KG)	4 of 11 (36.4%)	9 of 11 (81.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23085743Aikawa N, Kusachi S, Mikamo H, Takesue Y, Watanabe S, Tanaka Y, Morita A, Tsumori K, Kato Y, Yoshinari T. Efficacy and safety of intravenous daptomycin in Japanese patients with skin and soft tissue infections. J Infect Chemother. 2013 Jun;19(3):447-55. doi: 10.1007/s10156-012-0501-9. Epub 2012 Oct 20.
Derived from this study: PubMed 26072149Takesue Y, Mikamo H, Kusachi S, Watanabe S, Takahashi K, Yoshinari T, Ishii M, Aikawa N. Correlation between pharmacokinetic/pharmacodynamic indices and clinical outcomes in Japanese patients with skin and soft tissue infections treated with daptomycin: analysis of a phase III study. Diagn Microbiol Infect Dis. 2015 Sep;83(1):77-81. doi: 10.1016/j.diagmicrobio.2015.05.013. Epub 2015 May 28.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Staphylococcal Infection

RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daptomycin 4 mg/kg, Comparator: vancomycin and Daptomycin 6 mg/kg in people with Staphylococcal Infection, run by Merck Sharp & Dohme 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 2 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 24 Mar 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 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 15 Jun 2011). 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?

Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) (time frame: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)). The study lists 2 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 NCT00770341, which also lists 2 linked publications.

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 2017.