Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA)Phase 2NCT01211470

Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus

A Phase 2 study testing Daptomycin and PMX-30063-investigational drug in people with Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA) and (Susceptible or Methicillin Resistant), run by PolyMedix, Inc. at 8 sites in 3 countries.

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 study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). Read more about this study

Who is it for?: Ages 18 to 84 years
Conditions the study is for: Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA), (Susceptible or Methicillin Resistant)
What is being tested?: Daptomycin and PMX-30063-investigational drug
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 215 participants
Where: 8 sitesin 3 countries
Study dates: Oct 2010to Mar 2012
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 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of ABSSSI in which S. aureus is clinically suspected to be the likely pathogen
Clinical manifestation of subjects' ABSSSI must include the presence of purulent material suitable for microbiologic culture, Gram stain examination and PCR assay.
The ABSSSI must be 75 cm2 or greater in size in order for the subject to be eligible for this study. This includes the primary and surrounding erythema, swelling or induration.
Super-infected eczema or other chronic medical conditions (e.g., atopic dermatitis, hidradentitis suppurativa) characterized by prominent signs of inflammation for an extended period even after successful bacterial eradication. (Subjects with an ABSSSI that involves an anatomic location in which there is no evidence of a chronic skin condition are eligible for enrollment.)

Who cannot join

Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study.
History of peripheral neuropathy of any form or etiology
Anticipated need for prolonged antibiotic therapy (i.e., >8 days)
ABSSSI known or suspected to be caused exclusively by Gram negative pathogens or anaerobes (both Gram positive or Gram negative)
Diabetic foot infection: defined as a subacute or chronic infection (> 4 weeks) below the ankle in a patient with diabetic neuropathy
Infected burns
Known infection with human immunodeficiency virus (HIV) and a CD4 count < 200/mm3
Active hepatitis B or hepatitis C receiving treatment with interferon or other immunosuppressive therapy

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

Canada6 sites

Study site
Chicoutimi, Quebec, G7H 5H6
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Hamilton, Ontario, L8N 4A6
Study site
Québec, Quebec, G1V 4X7
Study site
Sherbrooke, Quebec, J1H 5N4
Study site
Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Russia1 site

11 Sites
Multiple

Other trials in Russia

Ukraine1 site

5 Sites
Multiple

Other trials in Ukraine

About this study

Official title: Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of PMX-30063 As Initial Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus Aureus

The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).

Conditions: Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA), (Susceptible or Methicillin Resistant)
Being tested: Daptomycin, PMX-30063-investigational drug
Keywords: MRSA, ABSSSI, Staphylococcus aureus
Medical subject headings: Disease Susceptibility, Staphylococcal Infections

What participants receive

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

DaptomycinDrug
Active Comparator: Daptomycin.
PMX-30063-investigational drugDrug
Experimental: PMX-30063

Study groups in NCT01211470
Study group	Role	What they receive
PMX-30063	Experimental	3 arms of PMX-300063 Receives: Drug: PMX-30063-investigational drug
Daptomycin.	Active comparator	Daptomycin will be administered according to the approved product monograph information for ABSSSI. Receives: Drug: Daptomycin

What is being measured

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

The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). The primary measure of efficacy will be bacteriologic eradication at end of treatment of S. aureus (either Methicillin-susceptible (MSSA) or Methicillin-resistant (MRSA)) in subjects with ABSSSI and having S. aureus isolated from an appropriate infection site prior to randomization.
The secondary objectives are clinical responses, safety and pharokinetics of PMX-300063.
Measured: Eradication at end of treatment (day 7/8)

Timeline

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

Oct 2010Mar 2012

First posted29 Sep 2010 (estimated)
Study startOct 2010
Primary completionDec 2011
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA)Studies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211470
Sponsor's protocol ID: PROTOCOL PMX63-203
Status last verified: May 2012
First submitted: 27 Sep 2010
Last updated: 17 May 2012
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of PMX-30063 As Initial Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus Aureus
ClinicalTrials.gov ID: NCT01211470
Acronym / sponsor ID: PROTOCOL PMX63-203
Conditions: Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA), (Susceptible or Methicillin Resistant)
Keywords: MRSA, ABSSSI, Staphylococcus aureus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: PolyMedix, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Dec 2011 (actual)
Study completion: Mar 2012 (actual)
First posted: 29 Sep 2010 (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.

The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PMX-30063	Experimental	Drug: PMX-30063-investigational drug3 arms of PMX-300063
Daptomycin.	Active comparator	Drug: DaptomycinDaptomycin will be administered according to the approved product monograph information for ABSSSI.

Who may qualify

Ages: 18 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have a diagnosis of ABSSSI in which S. aureus is clinically suspected to be the likely pathogen
Clinical manifestation of subjects' ABSSSI must include the presence of purulent material suitable for microbiologic culture, Gram stain examination and PCR assay.
The ABSSSI must be 75 cm2 or greater in size in order for the subject to be eligible for this study. This includes the primary and surrounding erythema, swelling or induration.
Super-infected eczema or other chronic medical conditions (e.g., atopic dermatitis, hidradentitis suppurativa) characterized by prominent signs of inflammation for an extended period even after successful bacterial eradication. (Subjects with an ABSSSI that involves an anatomic location in which there is no evidence of a chronic skin condition are eligible for enrollment.)

Key exclusion criteria (8 listed)

Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study.
History of peripheral neuropathy of any form or etiology
Anticipated need for prolonged antibiotic therapy (i.e., >8 days)
ABSSSI known or suspected to be caused exclusively by Gram negative pathogens or anaerobes (both Gram positive or Gram negative)
Diabetic foot infection: defined as a subacute or chronic infection (> 4 weeks) below the ankle in a patient with diabetic neuropathy

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
DaptomycinActive Comparator: Daptomycin.	Drug	Daptomycin.
PMX-30063-investigational drugExperimental: PMX-30063	Drug	PMX-30063

Primary outcome

The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
Time frame: Eradication at end of treatment (day 7/8)
The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). The primary measure of efficacy will be bacteriologic eradication at end of treatment of S. aureus (either Methicillin-susceptible (MSSA) or Methicillin-resistant (MRSA)) in subjects with ABSSSI and having S. aureus isolated from an appropriate infection site prior to randomization. The secondary objectives are clinical responses, safety and pharokinetics of PMX-300063.

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 17 May 2012.

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.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 8 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 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada, Russia, Ukraine. 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?

The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). (time frame: Eradication at end of treatment (day 7/8)). 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 NCT01211470.

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 17 May 2012.