A Phase 2 interventional study of delafloxacin and delafloxacin in Skin Structure Infections, Bacterial Skin Diseases and Staphylococcal Skin Infections, sponsored by Melinta Therapeutics, Inc.. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-14.
Sponsored by Melinta Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 150 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Melinta Therapeutics, Inc. is the lead sponsor of 30 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Exclusion Criteria:
Drug: delafloxacin
Drug: delafloxacin
Drug: tigecycline
300 mg intravenous every 12 hours
450 mg intravenous every 12 hours
100 mg then 50 mg intravenous tigecycline every 12 hours
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.
Time frame: 14-21 days after the last dose of study drug
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.
Time frame: 14-21 days after the last dose of study drug
This study targeted participants with complicated skin and skin structure infections (cSSSI), i.e. infections involving subcutaneous tissues or requiring surgical intervention. Patients could have one of three infection types: wound infection, abscess, or cellulitis.
| Milestone | Delafloxacin 300 mg IV q12h | Delafloxacin 450 mg IV q12h | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h |
|---|---|---|---|
| Started | 49 | 51 | 50 |
| Completed | 46 | 47 | 42 |
| Not completed | 3 | 4 | 8 |
| Withdrew: Adverse event | 0 | 2 | 3 |
| Withdrew: Lost to follow-up | 2 | 0 | 3 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 2 |
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.
| Participants | Delafloxacin 300 mg IV q12h | Delafloxacin 450 mg IV q12h | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h |
|---|---|---|---|
| Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | 33 | 37 | 31 |
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.
| Participants | Delafloxacin 300 mg IV q12h | Delafloxacin 450 mg IV q12h | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h |
|---|---|---|---|
| Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) | 13 | 19 | 12 |
Collected over All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Delafloxacin 300 mg IV q12h | — | 1/49 (2%) | 14/49 (28.6%) |
| Delafloxacin 450 mg IV q12h | — | 3/51 (5.9%) | 32/51 (62.7%) |
| Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h | — | 3/50 (6%) | 36/50 (72%) |
| Event | Delafloxacin 300 mg IV q12h | Delafloxacin 450 mg IV q12h | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h |
|---|---|---|---|
| Femoral neck fractureInjury, poisoning and procedural complications | 1/49 | 0/51 | 0/50 |
| CellulitisInfections and infestations | 0/49 | 0/51 | 1/50 |
| Cerebellar infarctionNervous system disorders | 0/49 | 0/51 | 1/50 |
| Duodenal ulcer hemorrhageGastrointestinal disorders | 0/49 | 0/51 | 1/50 |
| Subclavian vein thrombosisVascular disorders | 0/49 | 0/51 | 1/50 |
| BradycardiaCardiac disorders | 0/49 | 1/51 | 0/50 |
| ConvulsionNervous system disorders | 0/49 | 1/51 | 0/50 |
| OsteomyelitisInfections and infestations | 0/49 | 1/51 | 0/50 |
| Event | Delafloxacin 300 mg IV q12h | Delafloxacin 450 mg IV q12h | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h |
|---|---|---|---|
| NauseaGastrointestinal disorders | 6/49 | 13/51 | 23/50 |
| VomitingGastrointestinal disorders | 0/49 | 6/51 | 14/50 |
| DiarrheaGastrointestinal disorders | 5/49 | 12/51 | 5/50 |
| Infusion site painGeneral disorders | 0/49 | 7/51 | 0/50 |
| HeadacheNervous system disorders | 0/49 | 4/51 | 6/50 |
| ConstipationGastrointestinal disorders | 0/49 | 0/51 | 4/50 |
| DizzinessNervous system disorders | 0/49 | 1/51 | 4/50 |
| FatigueGeneral disorders | 0/49 | 4/51 | 0/50 |
| Subcutaneous abscessInfections and infestations | 0/49 | 4/51 | 0/50 |
| Alanine aminotransferase increasedInvestigations | 3/49 | 0/51 | 0/50 |
| Age, Continuous(years) | Delafloxacin 300 mg IV q12h | Delafloxacin 450 mg IV q12h | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h | Total |
|---|---|---|---|---|
| Mean | 42.7 ± 15.10 | 37.2 ± 14.35 | 40.4 ± 13.83 | 40.1 ± 14.51 |
| Sex: Female, Male(Participants) | Delafloxacin 300 mg IV q12h | Delafloxacin 450 mg IV q12h | Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h | Total |
|---|---|---|---|---|
| Female | 18 | 15 | 15 | 48 |
| Male | 31 | 36 | 35 | 102 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Melinta Therapeutics, Inc.