Skin and Subcutaneous Tissue Bacterial InfectionsPhase 3NCT01811732
Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Phase 3 study testing Delafloxacin, Vancomycin and Aztreonam in people with Skin and Subcutaneous Tissue Bacterial Infections, run by Melinta Therapeutics, Inc. at 50 sites in 7 countries.
Trial summary
This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin and Subcutaneous Tissue Bacterial Infections
- What is being tested?
- Delafloxacin, Vancomycin and Aztreonam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 50 sitesin 7 countries
- Study dates
- Apr 2013to Jul 2014
- 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 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 a diagnosis of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm^2 and at least two signs of systemic infection
- In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy, and the subject must be able and willing to comply with protocol requirements
Who cannot join
- A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator
- Women who are pregnant or lactating
- Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response, including infection involving a prosthetic joint, human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas gangrene; burns covering ≥10% of body surface area; severely impaired arterial blood supply to an extremity with an ABSSSI, deep vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or multiple debridement procedures
- Receipt of systemic antibiotic therapy in the 14 days before enrollment unless 1 of the following was documented:
- Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
- Recently (within 14 days) completed a treatment course with an antibacterial drug for an infection other than ABSSSI and the drug does not have activity against bacterial pathogens that cause ABSSSI.
- Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.
- Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study including severe cardiac disease, known history of liver disease, end-stage renal disease, malignancy, psychiatric disorder, ongoing treatment for seizures or untreated history of seizures, or life expectancy of <3 months
Trial locations and contacts
50 sites in 7 countries.
50 sites in 7 countries
United States17 sites
Melinta Investigational Site
Anaheim, California, 92804
Melinta Investigational Site
Butte, Montana, 59701
Melinta Investigational Site
Chula Vista, California, 91911
Melinta Investigational Site
La Mesa, California, 91942
Melinta Investigational Site
Las Vegas, Nevada, 89109
Melinta Investigational Site
Long Beach, California, 90813
Melinta Investigational Site
Los Angeles, California, 90015
Melinta Investigational Site
Minneapolis, Minnesota, 55422
Melinta Investigational Site
Miramar, Florida, 33027
Melinta Investigational Site
Modesto, California, 95350
Melinta Investigational Site
Montgomery, Alabama, 36106
Melinta Investigational Site
Oceanside, California, 92056
Melinta Investigational Site
Pasadena, California, 91105
Melinta Investigational Site
Richmond, Texas, 77469
Melinta Investigational Site
Smyrna, Tennessee, 37167
Melinta Investigational Site
Somers Point, New Jersey, 08244
Melinta Investigational Site
Stockton, California, 95204
Ukraine10 sites
Melinta Investigational Site
Chemivtsi, 58002
Melinta Investigational Site
Cherkasy, 18009
Melinta Investigational Site
Dnipropetrovsk, 49005
Melinta Investigational Site
Dnipropetrovsk, 49027
Melinta Investigational Site
Ivano-Frankivsk, 61037
Melinta Investigational Site
Ivano-Frankivsk, 76014
Melinta Investigational Site
Klarkiv, 61037
Melinta Investigational Site
Lviv, 79059
Melinta Investigational Site
Odesa, 65025
Melinta Investigational Site
Zaporizhzhya, 69104
Israel6 sites
Melinta Investigational Site
Haifa, 31048
Melinta Investigational Site
Haifa, 31096
Melinta Investigational Site
Kfar Saba, 44281
Melinta Investigational Site
Nazareth, 16100
Melinta Investigational Site
Safed, 13100
Melinta Investigational Site
Tel Aviv, 64239
Latvia5 sites
Melinta Investigational Site
Daugavpils, LV-5417
Melinta Investigational Site
Liepāja, LV-3414
Melinta Investigational Site
Riga, LV-1002
Melinta Investigational Site
Riga, LV-1006
Melinta Investigational Site
Valmiera, LV-4201
Spain5 sites
Melinta Investigational Site
Barcelona, 08003
Melinta Investigational Site
Barcelona, 08221
Melinta Investigational Site
Granada, 18014
Melinta Investigational Site
Málaga, 29010
Melinta Investigational Site
Valencia, 46010
Russia4 sites
Melinta Investigational Site
Moscow, 111539
Melinta Investigational Site
Perm, 614107
Melinta Investigational Site
Saint Petersberg, 194354
Melinta Investigational Site
Vsevolozhsk, 188640
Croatia3 sites
Melinta Investigational Site
Slavonski Brod, 35000
Melinta Investigational Site
Zagreb, 10000
Melinta Investigational Site
Zagreb, 10001
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections
This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).
Read the detailed description
The efficacy and safety of delafloxacin, compared to that of vancomycin plus aztreonam, will be evaluated in a population of patients with acute bacterial skin and soft tissue infections (ABSSSI), including major cutaneous abscesses, wound infections, cellulitis/erysipelas, and burn-related infections.
- Being tested
- Delafloxacin, Vancomycin, Aztreonam, Placebo
- Keywords
- Bacterial skin infection, skin infection, infection, skin, delafloxacin, vancomycin, aztreonam, MRSA bacteria, bacterial infection, Anti-Infective Agents, Anti-Bacterial Agents
- Medical subject headings
- Skin Diseases, Bacterial, Cellulitis, Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelafloxacinDrug
Also called RX-3341
Delafloxacin
VancomycinDrug
Vancomycin
AztreonamDrug
Aztreonam
PlaceboDrug
Also called 5% Dextrose, D5W
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Delafloxacin plus placebo | Experimental | Delafloxacin 300 mg IV every 12 hours for a minimum of 10 and up to a maximum of 28 doses Receives: Drug: Delafloxacin; Drug: Placebo |
| Vancomycin plus Aztreonam + placebo | Active comparator | Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures) Receives: Drug: Vancomycin; Drug: Aztreonam; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response at 48 to 72 Hours (FDA Primary Endpoint)
A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.
Measured: 48 to 72 hours after starting treatment
Secondary outcomes (2)
Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)
A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.
A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing).
Measured: Study Day 14 +/- 1 day
Investigator Assessment at the Late Follow-up Visit
A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.
A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing).
Measured: Study Day 21 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
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 (3)Papers the sponsor has linked to this study.
- Other trials for Skin and Subcutaneous Tissue Bacterial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sue K. Cammarata, MD, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811732
- Sponsor's protocol ID
- RX-3341-302
- Other IDs
- 2012-001767-71
- Status last verified
- Aug 2017
- First submitted
- 8 Mar 2013
- Last updated
- 27 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lodise T, Corey R, Hooper D, Cammarata S. Safety of Delafloxacin: Focus on Adverse Events of Special Interest. Open Forum Infect Dis. 2018 Sep 10;5(10):ofy220. doi: 10.1093/ofid/ofy220. eCollection 2018 Oct.
PubMed 30349845Pullman J, Gardovskis J, Farley B, Sun E, Quintas M, Lawrence L, Ling R, Cammarata S; PROCEED Study Group. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study. J Antimicrob Chemother. 2017 Dec 1;72(12):3471-3480. doi: 10.1093/jac/dkx329.
PubMed 29029278McCurdy S, Lawrence L, Quintas M, Woosley L, Flamm R, Tseng C, Cammarata S. In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00772-17. doi: 10.1128/AAC.00772-17. Print 2017 Sep.
PubMed 28630189
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT01811732
- Acronym / sponsor ID
- RX-3341-302
- Keywords
- Bacterial skin infection, skin infection, infection, skin, delafloxacin, vancomycin, aztreonam, MRSA bacteria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Mar 2013 (estimated)
- Results
- Posted 24 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).
Detailed description
The efficacy and safety of delafloxacin, compared to that of vancomycin plus aztreonam, will be evaluated in a population of patients with acute bacterial skin and soft tissue infections (ABSSSI), including major cutaneous abscesses, wound infections, cellulitis/erysipelas, and burn-related infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delafloxacin plus placebo | Experimental | Drug: Delafloxacin, Drug: PlaceboDelafloxacin 300 mg IV every 12 hours for a minimum of 10 and up to a maximum of 28 doses |
| Vancomycin plus Aztreonam + placebo | Active comparator | Drug: Vancomycin, Drug: Aztreonam, Drug: PlaceboVancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥ 18 years of age) men or women with a diagnosis of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm^2 and at least two signs of systemic infection
- In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy, and the subject must be able and willing to comply with protocol requirements
Key exclusion criteria (8 listed)
- A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator
- Women who are pregnant or lactating
- Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response, including infection involving a prosthetic joint, human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas gangrene; burns covering ≥10% of body surface area; severely impaired arterial blood supply to an extremity with an ABSSSI, deep vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or multiple debridement procedures
- Receipt of systemic antibiotic therapy in the 14 days before enrollment unless 1 of the following was documented:
- Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study including severe cardiac disease, known history of liver disease, end-stage renal disease, malignancy, psychiatric disorder, ongoing treatment for seizures or untreated history of seizures, or life expectancy of <3 months
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 |
|---|---|---|
| DelafloxacinAlso: RX-3341Delafloxacin | Drug | Delafloxacin plus placebo |
| VancomycinVancomycin | Drug | Vancomycin plus Aztreonam + placebo |
| AztreonamAztreonam | Drug | Vancomycin plus Aztreonam + placebo |
| PlaceboAlso: 5% Dextrose, D5WPlacebo | Drug | Delafloxacin plus placebo, Vancomycin plus Aztreonam + placebo |
Primary outcome
Objective Response at 48 to 72 Hours (FDA Primary Endpoint)
Time frame: 48 to 72 hours after starting treatment
A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.
2 secondary outcomes
Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)
Time frame: Study Day 14 +/- 1 day
Investigator Assessment at the Late Follow-up Visit
Time frame: Study Day 21 to 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30349845Lodise T, Corey R, Hooper D, Cammarata S. Safety of Delafloxacin: Focus on Adverse Events of Special Interest. Open Forum Infect Dis. 2018 Sep 10;5(10):ofy220. doi: 10.1093/ofid/ofy220. eCollection 2018 Oct.
- Derived from this study: PubMed 29029278Pullman J, Gardovskis J, Farley B, Sun E, Quintas M, Lawrence L, Ling R, Cammarata S; PROCEED Study Group. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study. J Antimicrob Chemother. 2017 Dec 1;72(12):3471-3480. doi: 10.1093/jac/dkx329.
- Derived from this study: PubMed 28630189McCurdy S, Lawrence L, Quintas M, Woosley L, Flamm R, Tseng C, Cammarata S. In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00772-17. doi: 10.1128/AAC.00772-17. Print 2017 Sep.
- Individual participant dataSharing planned: No
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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.
Sue K. Cammarata, MD study director
Melinta Therapeutics, Inc.
50 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Delafloxacin, Vancomycin and Aztreonam in people with Skin and Subcutaneous Tissue Bacterial Infections, run by Melinta Therapeutics, Inc. at 50 sites in 7 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 2 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 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Ukraine, Israel, Latvia, Spain and 2 more countries. 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 24 Aug 2017). 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?
Objective Response at 48 to 72 Hours (FDA Primary Endpoint) (time frame: 48 to 72 hours after starting treatment). 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 NCT01811732, which also lists 3 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 27 Sep 2017.