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Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01984684
First Posted: November 15, 2013
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.
Results First Submitted: July 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Skin Structures and Soft Tissue Infections
Interventions: Drug: delafloxacin
Drug: vancomycin
Drug: aztreonam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Delafloxacin 300 mg IV Q12H for 6 doses, 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
Vancomycin Plus Aztreonam Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total

Participant Flow:   Overall Study
    Delafloxacin   Vancomycin Plus Aztreonam
STARTED   423   427 
COMPLETED   366   368 
NOT COMPLETED   57   59 
Lost to Follow-up                25                24 
Adverse Event                8                12 
Withdrawal by Subject                9                9 
Lack of Efficacy                3                6 
Physician Decision                4                2 
Protocol Violation                4                2 
Death                0                1 
Noncompliance with study drug                2                1 
Subject incarcerated                1                0 
Study drug not available at site                1                1 
Subject had inadequate IV access                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) Population included all patients who were randomly assigned to treatment.

Reporting Groups
  Description
Delafloxacin 300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total
Vancomycin Plus Aztreonam Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total
Total Total of all reporting groups

Baseline Measures
   Delafloxacin   Vancomycin Plus Aztreonam   Total 
Overall Participants Analyzed 
[Units: Participants]
 423   427   850 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.2  (15.98)   50.2  (16.03)   50.7  (16.00) 
Age, Customized 
[Units: Participants]
Count of Participants
     
<= 65 years   344   352   696 
> 65 years   79   75   154 
> 75 years   35   31   66 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      161  38.1%      151  35.4%      312  36.7% 
Male      262  61.9%      276  64.6%      538  63.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      132  31.2%      99  23.2%      231  27.2% 
Not Hispanic or Latino      291  68.8%      328  76.8%      619  72.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      12   2.8%      7   1.6%      19   2.2% 
Asian      11   2.6%      15   3.5%      26   3.1% 
Native Hawaiian or Other Pacific Islander      2   0.5%      2   0.5%      4   0.5% 
Black or African American      13   3.1%      18   4.2%      31   3.6% 
White      348  82.3%      355  83.1%      703  82.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      37   8.7%      30   7.0%      67   7.9% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Europe   165   173   338 
North America   202   196   398 
Mexico   8   4   12 
Brazil   0   5   5 
Chile   1   1   2 
Peru   34   29   63 
South Korea   8   13   21 
Taiwan   1   1   2 
Argentina   4   5   9 
BMI (Body Mass Index) 
[Units: Kg/m2]
Mean (Standard Deviation)
 30.4  (7.44)   30.7  (7.54)   30.5  (7.49) 
BMI category 
[Units: Participants]
Count of Participants
     
< 30 kg/m2      212  50.1%      213  49.9%      425  50.0% 
>= 30 kg/m2      211  49.9%      214  50.1%      425  50.0% 
Presence of diabetes 
[Units: Participants]
Count of Participants
 53   54   107 


  Outcome Measures
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1.  Primary:   Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements of the Leading Edge.   [ Time Frame: 48 to 72 hrs after starting treatment ]

2.  Secondary:   Investigator-assessed Response of Signs and Symptoms of Infection at the Follow up Visit (European Medicines Agency [EMA] Primary Endpoint)   [ Time Frame: Study Day 14 ± 1 ]

3.  Secondary:   Investigator-assessed Response of Signs and Symptoms of Infection at the Late Follow-up Visit   [ Time Frame: Study Day 21 to 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sue Cammarata (Chief Medical Officer)
Organization: Melinta Therapeutics, Inc.
phone: 1-844-MELINTA (1-844-635-4682)
e-mail: clinicaltrials@melinta.com



Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01984684     History of Changes
Other Study ID Numbers: RX-3341-303
First Submitted: November 8, 2013
First Posted: November 15, 2013
Results First Submitted: July 26, 2017
Results First Posted: August 28, 2017
Last Update Posted: November 17, 2017