Skin Structure InfectionsPhase 2NCT00719810
Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
A Phase 2 study testing delafloxacin and tigecycline in people with Skin Structure Infections and Bacterial Skin Diseases, run by Melinta Therapeutics, Inc. at 14 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Structure Infections, Bacterial Skin Diseases, Staphylococcal Skin Infections
- What is being tested?
- delafloxacin and tigecycline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jun 2008to Oct 2008
- Phase
- Phase 2
- 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
- Adult (≥18 years of age) men or women with cSSSI
- Diagnosis of one of the following 3 types of cSSSI: wound infection that has developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment
- Sexually active men and women of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug
- The patient must be willing to comply with protocol requirements
Who cannot join
- Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline or tetracycline derivatives
- Chronic or underlying skin condition at the site of infection
- Infection involving prosthetic materials or foreign bodies (unless prosthetic material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
- An infection that would normally have a high cure rate after surgical incision alone
- Any infection expected to require other antimicrobial agents in addition to study drug
- Receipt of >24 hours of systemic antibiotic therapy in the 7 days before enrollment
Show all 9Show fewer
- A severely compromised immune system
- History of Child-Pugh Class B or C liver disease or severe renal impairment (creatinine clearance of <30 mL/minute)
- Pregnancy or lactation
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Physician Alliance Research Center
Anaheim, California
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia
St. James Health Care
Butte, Montana
Southeast Regional Research Group
Columbus, Georgia
Riverside Methodist Hospital
Columbus, Ohio
Internal Medicine Associates of Lee County
Fort Myers, Florida
Quality of Life Medical Center, LLC
Hawaiian Gardens, California
West Houston Clinical Research Services
Houston, Texas
Westbury Medical Clinic
Houston, Texas
Southeast Regional Research Group
Ludowici, Georgia
Tri City Medical Center
Oceanside, California
Crest Clinical Trials
Santa Ana, California
Southeast Regional Research Group
Savannah, Georgia
About this study
Official title: A Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of RX 3341 Compared With Tigecycline for the Treatment of Complicated Skin and Skin Structure Infections
The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.
- Being tested
- delafloxacin, tigecycline
- Keywords
- complicated, skin
- Medical subject headings
- Skin Diseases, Bacterial, Staphylococcal Skin Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delafloxacinDrug
300 mg intravenous every 12 hours
delafloxacinDrug
450 mg intravenous every 12 hours
tigecyclineDrug
100 mg then 50 mg intravenous tigecycline every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: delafloxacin |
| 2 | Experimental | Not described Receives: Drug: delafloxacin |
| 3 | Active comparator | Not described Receives: Drug: tigecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
Measured: 14-21 days after the last dose of study drug
Secondary outcomes (1)
Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
Measured: 14-21 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionOct 2008
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 (1)Papers the sponsor has linked to this study.
- Other trials for Skin Structure 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeanne Breen, MD, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719810
- Sponsor's protocol ID
- RX-3341-201
- Status last verified
- Jun 2014
- First submitted
- 18 Jul 2008
- Last updated
- 14 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
O'Riordan W, Mehra P, Manos P, Kingsley J, Lawrence L, Cammarata S. A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections. Int J Infect Dis. 2015 Jan;30:67-73. doi: 10.1016/j.ijid.2014.10.009. Epub 2014 Oct 30.
PubMed 25448332
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of RX 3341 Compared With Tigecycline for the Treatment of Complicated Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00719810
- Acronym / sponsor ID
- RX-3341-201
- Keywords
- complicated, skin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 3 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: delafloxacin |
| 2 | Experimental | Drug: delafloxacin |
| 3 | Active comparator | Drug: tigecycline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥18 years of age) men or women with cSSSI
- Diagnosis of one of the following 3 types of cSSSI: wound infection that has developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment
- Sexually active men and women of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug
- The patient must be willing to comply with protocol requirements
Key exclusion criteria (9 listed)
- Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline or tetracycline derivatives
- Chronic or underlying skin condition at the site of infection
- Infection involving prosthetic materials or foreign bodies (unless prosthetic material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
- An infection that would normally have a high cure rate after surgical incision alone
- Any infection expected to require other antimicrobial agents in addition to study drug
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 |
|---|---|---|
| delafloxacin300 mg intravenous every 12 hours | Drug | 1 |
| delafloxacin450 mg intravenous every 12 hours | Drug | 2 |
| tigecycline100 mg then 50 mg intravenous tigecycline every 12 hours | Drug | 3 |
Primary outcome
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
Time frame: 14-21 days after the last dose of study drug
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
1 secondary outcome
Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)
Time frame: 14-21 days after the last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25448332O'Riordan W, Mehra P, Manos P, Kingsley J, Lawrence L, Cammarata S. A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections. Int J Infect Dis. 2015 Jan;30:67-73. doi: 10.1016/j.ijid.2014.10.009. Epub 2014 Oct 30.
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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.
Jeanne Breen, MD study director
Melinta Therapeutics, Inc.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing delafloxacin and tigecycline in people with Skin Structure Infections and Bacterial Skin Diseases, run by Melinta Therapeutics, Inc. at 14 sites in 2 countries.
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 9 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 3 Feb 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?
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population (time frame: 14-21 days after the last dose of study drug). 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 NCT00719810, 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 Jul 2014.