Soft Tissue InfectionsPhase 2NCT00426933
Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections
A Phase 2 study testing Daptomycin and Vancomycin in people with Soft Tissue Infections, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Soft Tissue Infections
- What is being tested?
- Daptomycin and Vancomycin
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Sep 2007
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained
- Male or female ≥18 years of age
- If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test
- Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment
- Gram-positive infecting pathogen
- Physician determination that vancomycin would be the initial treatment of choice
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- At least three clinical signs and symptoms associated with the cSSSI:
- Pain;
- Tenderness to palpation;
- Elevated Temperature;
- Elevated White blood count;
- Swelling and/or induration;
- Erythema (>1 cm beyond edge of wound or abscess);
- Pus formation;
- Creatinine clearance of ≥50 mL/min.
Who cannot join
- MSSA
- Known or suspected bacteremia, osteomyelitis, or endocarditis
- Primary study infection of an uncomplicated nature such as furuncles, simple abscesses, cellulitis not requiring i.v., perirectal abscess, hidradenitis suppurativa, third degree burn infections or other minor infections;
- Conditions where required surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation);
- Necrotizing infections or concomitant gangrene;
- Myositis with or without skin and skin structure infections;
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- Hemodialysis or peritoneal dialysis;
- BMI ≥40 kg/m2;
- Previous antibiotics exceeding 24 hours within the 48 hours prior to the first dose of study drug
- Patients admitted for rhabdomyolysis including drug overdose
- Neutropenic patients with absolute neutrophil count ≤500 cells/mm3
- Known HIV-infected patients with CD4 count ≤200 cells/ mm3;
- Baseline CPK values ≥2 X ULN (upper limit of normal);
- Has received an investigational drug within 30 days of study entry;
- Known to be allergic or intolerant to study medications;
- unlikely to comply with study procedures
- Is expected to receive HMG CoA Reductase Inhibitors from enrollment through End of Treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, 83404
About this study
Official title: Phase 2 Multicenter Randomized Semi-Single Blind Study to Compare Efficacy and Safety of High-dose Short Duration Daptomycin With Conventional Therapy in Complicated Skin and Skin Structure Infections Due to Gram-positive Bacteria
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
Read the detailed description
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
The main criteria for evaluation will be:
- Efficacy
- Safety
- Microbiologic eradication
- Conditions
- Soft Tissue Infections
- Being tested
- Daptomycin, Vancomycin
- Keywords
- cSSSI, MRSA
- Medical subject headings
- Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
VancomycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rate at TOC
Secondary outcomes (2)
difference between clinical response rates at EOT
microbiological eradication rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Nathan, D.O., Principal investigator, Idaho Falls Infectious Diseases, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426933
- Sponsor's protocol ID
- DAP-HDSD-06-01
- Status last verified
- Sep 2010
- First submitted
- 23 Jan 2007
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Katz DE, Lindfield KC, Steenbergen JN, Benziger DP, Blackerby KJ, Knapp AG, Martone WJ. A pilot study of high-dose short duration daptomycin for the treatment of patients with complicated skin and skin structure infections caused by gram-positive bacteria. Int J Clin Pract. 2008 Sep;62(9):1455-64. doi: 10.1111/j.1742-1241.2008.01854.x. Epub 2008 Jul 25.
PubMed 18662172
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicenter Randomized Semi-Single Blind Study to Compare Efficacy and Safety of High-dose Short Duration Daptomycin With Conventional Therapy in Complicated Skin and Skin Structure Infections Due to Gram-positive Bacteria
- ClinicalTrials.gov ID
- NCT00426933
- Acronym / sponsor ID
- DAP-HDSD-06-01
- Conditions
- Soft Tissue Infections
- Keywords
- cSSSI, MRSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 25 Jan 2007 (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.
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
Detailed description
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
The main criteria for evaluation will be:
- Efficacy
- Safety
- Microbiologic eradication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Informed consent obtained
- Male or female ≥18 years of age
- If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test
- Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment
- Gram-positive infecting pathogen
Key exclusion criteria (17 listed)
- MSSA
- Known or suspected bacteremia, osteomyelitis, or endocarditis
- Primary study infection of an uncomplicated nature such as furuncles, simple abscesses, cellulitis not requiring i.v., perirectal abscess, hidradenitis suppurativa, third degree burn infections or other minor infections;
- Conditions where required surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation);
- Necrotizing infections or concomitant gangrene;
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 | – |
| Vancomycin | Drug | – |
Primary outcome
Clinical Response Rate at TOC
2 secondary outcomes
difference between clinical response rates at EOT
microbiological eradication rates
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 14 Sep 2010.
- Derived from this study: PubMed 18662172Katz DE, Lindfield KC, Steenbergen JN, Benziger DP, Blackerby KJ, Knapp AG, Martone WJ. A pilot study of high-dose short duration daptomycin for the treatment of patients with complicated skin and skin structure infections caused by gram-positive bacteria. Int J Clin Pract. 2008 Sep;62(9):1455-64. doi: 10.1111/j.1742-1241.2008.01854.x. Epub 2008 Jul 25.
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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.
Richard Nathan, D.O. principal investigator
Idaho Falls Infectious Diseases, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daptomycin and Vancomycin in people with Soft Tissue Infections, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
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 15 inclusion and 17 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 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Clinical Response Rate at TOC. 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 NCT00426933, 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 14 Sep 2010; AzTrials last refreshed its copy on 6 Nov 2026.