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

• Sponsor: Melinta Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01811732
• Collaborator: (none)
• Enrollment: 660
• Locations: 50
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site: 13.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

Condition or Disease	Intervention/Treatment	Phase
Skin and Subcutaneous Tissue Bacterial Infections	Drug: Delafloxacin; Drug: Vancomycin; Drug: Aztreonam; Drug: Placebo	Phase 3

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

• Study Type: Interventional
• Actual Enrollment: 660 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Delafloxacin plus placebo Delafloxacin 300 mg IV every 12 hours for a minimum of 10 and up to a maximum of 28 doses	Drug: Delafloxacin; Delafloxacin; Other Names: RX-3341 ; Drug: Placebo; Placebo; Other Names: 5% Dextrose D5W
Active Comparator: Vancomycin plus Aztreonam + placebo 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)	Drug: Vancomycin; Vancomycin; Drug: Aztreonam; Aztreonam; Drug: Placebo; Placebo; Other Names: 5% Dextrose D5W

Outcome Measures

Primary Outcome Measures

1. Objective Response at 48 to 72 Hours (FDA Primary Endpoint) [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.

Secondary Outcome Measures

1. Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint) [Study Day 14 +/- 1 day]

   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).

2. Investigator Assessment at the Late Follow-up Visit [Study Day 21 to 28]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).

2. 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.

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Melinta Investigational Site	Montgomery	Alabama	United States	36106
2	Melinta Investigational Site	Anaheim	California	United States	92804
3	Melinta Investigational Site	Chula Vista	California	United States	91911
4	Melinta Investigational Site	La Mesa	California	United States	91942
5	Melinta Investigational Site	Long Beach	California	United States	90813
6	Melinta Investigational Site	Los Angeles	California	United States	90015
7	Melinta Investigational Site	Modesto	California	United States	95350
8	Melinta Investigational Site	Oceanside	California	United States	92056
9	Melinta Investigational Site	Pasadena	California	United States	91105
10	Melinta Investigational Site	Stockton	California	United States	95204
11	Melinta Investigational Site	Miramar	Florida	United States	33027
12	Melinta Investigational Site	Minneapolis	Minnesota	United States	55422
13	Melinta Investigational Site	Butte	Montana	United States	59701
14	Melinta Investigational Site	Las Vegas	Nevada	United States	89109
15	Melinta Investigational Site	Somers Point	New Jersey	United States	08244
16	Melinta Investigational Site	Smyrna	Tennessee	United States	37167
17	Melinta Investigational Site	Richmond	Texas	United States	77469
18	Melinta Investigational Site	Slavonski Brod		Croatia	35000
19	Melinta Investigational Site	Zagreb		Croatia	10000
20	Melinta Investigational Site	Zagreb		Croatia	10001
21	Melinta Investigational Site	Haifa		Israel	31048
22	Melinta Investigational Site	Haifa		Israel	31096
23	Melinta Investigational Site	Kfar Saba		Israel	44281
24	Melinta Investigational Site	Nazareth		Israel	16100
25	Melinta Investigational Site	Safed		Israel	13100
26	Melinta Investigational Site	Tel Aviv		Israel	64239
27	Melinta Investigational Site	Daugavpils		Latvia	LV-5417
28	Melinta Investigational Site	Liepaja		Latvia	LV-3414
29	Melinta Investigational Site	Riga		Latvia	LV-1002
30	Melinta Investigational Site	Riga		Latvia	LV-1006
31	Melinta Investigational Site	Valmiera		Latvia	LV-4201
32	Melinta Investigational Site	Moscow		Russian Federation	111539
33	Melinta Investigational Site	Perm		Russian Federation	614107
34	Melinta Investigational Site	St. Petersberg		Russian Federation	194354
35	Melinta Investigational Site	Vsevolozhsk		Russian Federation	188640
36	Melinta Investigational Site	Barcelona		Spain	08003
37	Melinta Investigational Site	Barcelona		Spain	08221
38	Melinta Investigational Site	Granada		Spain	18014
39	Melinta Investigational Site	Malaga		Spain	29010
40	Melinta Investigational Site	Valencia		Spain	46010
41	Melinta Investigational Site	Chemivtsi		Ukraine	58002
42	Melinta Investigational Site	Cherkasy		Ukraine	18009
43	Melinta Investigational Site	Dnipropetrovsk		Ukraine	49005
44	Melinta Investigational Site	Dnipropetrovsk		Ukraine	49027
45	Melinta Investigational Site	Ivano-Frankivsk		Ukraine	61037
46	Melinta Investigational Site	Ivano-Frankivsk		Ukraine	76014
47	Melinta Investigational Site	Klarkiv		Ukraine	61037
48	Melinta Investigational Site	Lviv		Ukraine	79059
49	Melinta Investigational Site	Odessa		Ukraine	65025
50	Melinta Investigational Site	Zaporizhzhia		Ukraine	69104

Sponsors and Collaborators

• Melinta Therapeutics, Inc.

Investigators

• Study Director: Sue K. Cammarata, MD, Melinta Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melinta Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01811732
• Other Study ID Numbers: RX-3341-302; 2012-001767-71
• First Posted: Mar 15, 2013
• Last Update Posted: Sep 27, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Melinta Therapeutics, Inc.: Bacterial skin infection; skin infection; infection; skin; delafloxacin; vancomycin; aztreonam; MRSA bacteria; bacterial infection; Anti-Infective Agents; Anti-Bacterial Agents
• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Vancomycin; Aztreonam

Study Results

Participant Flow

Arm/Group Title	Delafloxacin Plus Placebo	Vancomycin Plus Aztreonam + Placebo
Arm/Group Description	300 mg IV every 12 hours, for a minimum of 10 and up to a maximum of 28 doses Delafloxacin: Delafloxacin Placebo: Placebo	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 Vancomycin: Vancomycin Aztreonam: Aztreonam Placebo: Placebo
Period Title: Overall Study
STARTED	331	329
COMPLETED	276	271
NOT COMPLETED	55	58

Baseline Characteristics

Arm/Group Title	Delafloxacin + Placebo	Vancomycin Plus Aztreonam + Placebo	Total
Arm/Group Description	300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses Delafloxacin: Delafloxacin Placebo: Placebo	Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses Vancomycin: Vancomycin Aztreonam: Aztreonam Placebo: Placebo	Total of all reporting groups
Overall Participants	331	329	660
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.3 (13.91)	45.3 (14.44)	45.8 (14.18)
Age, Customized (Count of Participants)
<= 65 years	309 93.4%	309 93.9%	618 93.6%
> 65 years	22 6.6%	20 6.1%	42 6.4%
> 75 years	7 2.1%	10 3%	17 2.6%
Sex: Female, Male (Count of Participants)
Female	125 37.8%	120 36.5%	245 37.1%
Male	206 62.2%	209 63.5%	415 62.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	101 30.5%	103 31.3%	204 30.9%
Not Hispanic or Latino	230 69.5%	226 68.7%	456 69.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	5 1.5%	2 0.6%	7 1.1%
Asian	1 0.3%	1 0.3%	2 0.3%
Native Hawaiian or Other Pacific Islander	1 0.3%	2 0.6%	3 0.5%
Black or African American	27 8.2%	19 5.8%	46 7%
White	297 89.7%	304 92.4%	601 91.1%
More than one race	0 0%	1 0.3%	1 0.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
North America	268 81%	274 83.3%	542 82.1%
Europe	63 19%	55 16.7%	118 17.9%
BMI (Body Mass Index) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	28.36 (6.423)	27.86 (6.363)	28.11 (6.393)
BMI ranges (Count of Participants)
< 25	113 34.1%	125 38%	238 36.1%
>= 25	218 65.9%	204 62%	422 63.9%
>= 30	120 36.3%	94 28.6%	214 32.4%
>= 35	53 16%	42 12.8%	95 14.4%
Presence of Diabetes (Count of Participants)
Count of Participants [Participants]	30 9.1%	27 8.2%	57 8.6%

Outcome Measures

1. Primary Outcome

Title	Objective Response at 48 to 72 Hours (FDA Primary Endpoint)
Description	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.
Time Frame	48 to 72 hours after starting treatment

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Delafloxacin Plus Placebo	Vancomycin Plus Aztreonam + Placebo
Arm/Group Description	300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses Delafloxacin: Delafloxacin Placebo: Placebo	Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses Vancomycin: Vancomycin Aztreonam: Aztreonam Placebo: Placebo
Measure Participants	331	329
Responder	259 78.2%	266 80.9%
Non-Responder	72 21.8%	63 19.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delafloxacin Plus Placebo, Vancomycin Plus Aztreonam + Placebo
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in sample rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Responder Rates
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 95%; -8.8 to 3.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)
Description	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).
Time Frame	Study Day 14 +/- 1 day

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Delafloxacin Plus Placebo	Vancomycin Plus Aztreonam + Placebo
Arm/Group Description	300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses Delafloxacin: Delafloxacin Placebo: Placebo	Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses Vancomycin: Vancomycin Aztreonam: Aztreonam Placebo: Placebo
Measure Participants	331	329
Cure	172 52%	166 50.5%
Improved	98 29.6%	108 32.8%
Failure	9 2.7%	7 2.1%
Indeterminate	52 15.7%	48 14.6%

3. Secondary Outcome

Title	Investigator Assessment at the Late Follow-up Visit
Description	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).
Time Frame	Study Day 21 to 28

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Delafloxacin Plus Placebo	Vancomycin Plus Aztreonam + Placebo
Arm/Group Description	300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses Delafloxacin: Delafloxacin Placebo: Placebo	Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses Vancomycin: Vancomycin Aztreonam: Aztreonam Placebo: Placebo
Measure Participants	331	329
Cure	233 70.4%	219 66.6%
Improved	32 9.7%	48 14.6%
Failure	9 2.7%	6 1.8%
Indeterminate/Missing	57 17.2%	56 17%

Adverse Events

Time Frame	Adverse event data were collected from the time the patient signed the ICF through the follow-up telephone contact 30 days after the last dose of study drug (up to 45 days).
Adverse Event Reporting Description	AE data are only included for the safety population which included all patients in the ITT population who received at least 1 dose of study drug.
Arm/Group Title	Delafloxacin Plus Placebo		Vancomycin Plus Aztreonam + Placebo
Arm/Group Description	300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses Delafloxacin: Delafloxacin Placebo: Placebo		Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses Vancomycin: Vancomycin Aztreonam: Aztreonam Placebo: Placebo
All Cause Mortality
	Delafloxacin Plus Placebo		Vancomycin Plus Aztreonam + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/324 (0.3%)		1/326 (0.3%)
Serious Adverse Events
	Delafloxacin Plus Placebo		Vancomycin Plus Aztreonam + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/324 (3.7%)		12/326 (3.7%)
Gastrointestinal disorders
Diarrhea	1/324 (0.3%)		0/326 (0%)
Gastric ulcer perforation	0/324 (0%)		1/326 (0.3%)
Hepatobiliary disorders
Hepatic cirrhosis	0/324 (0%)		1/326 (0.3%)
Infections and infestations
Cellulitis	2/324 (0.6%)		1/326 (0.3%)
Hepatitis C	1/324 (0.3%)		0/326 (0%)
Infection	1/324 (0.3%)		2/326 (0.6%)
Peritonitis	0/324 (0%)		1/326 (0.3%)
Sepsis	0/324 (0%)		1/326 (0.3%)
Septic Shock	1/324 (0.3%)		0/326 (0%)
Skin bacterial infection	1/324 (0.3%)		0/326 (0%)
Staphylococcal sepsis	1/324 (0.3%)		0/326 (0%)
Injury, poisoning and procedural complications
Overdose	0/324 (0%)		1/326 (0.3%)
Stab wound	0/324 (0%)		1/326 (0.3%)
Musculoskeletal and connective tissue disorders
Soft tissue necrosis	0/324 (0%)		1/326 (0.3%)
Nervous system disorders
Cervical radiculopathy	0/324 (0%)		1/326 (0.3%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/324 (0.3%)		0/326 (0%)
Psychiatric disorders
Depression	1/324 (0.3%)		0/326 (0%)
Major depression	1/324 (0.3%)		0/326 (0%)
Polysubstance dependence	1/324 (0.3%)		0/326 (0%)
Substance-induced mood disorder	1/324 (0.3%)		0/326 (0%)
Renal and urinary disorders
Renal failure acute	0/324 (0%)		1/326 (0.3%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/324 (0.3%)		0/326 (0%)
Pulmonary embolism	0/324 (0%)		1/326 (0.3%)
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum	1/324 (0.3%)		0/326 (0%)
Vascular disorders
Peripheral ischemia	0/324 (0%)		1/326 (0.3%)
Peripheral vascular disorder	0/324 (0%)		1/326 (0.3%)
Other (Not Including Serious) Adverse Events
	Delafloxacin Plus Placebo		Vancomycin Plus Aztreonam + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	91/324 (28.1%)		111/326 (34%)
Gastrointestinal disorders
Diarrhea	27/324 (8.3%)		10/326 (3.1%)
Nausea	24/324 (7.4%)		28/326 (8.6%)
General disorders
Infusion site extravasation	28/324 (8.6%)		44/326 (13.5%)
Infections and infestations
Infection	28/324 (8.6%)		25/326 (7.7%)
Nervous system disorders
Headache	10/324 (3.1%)		25/326 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Melinta has the right to first publication of results, which would be made in conjunction with the PIs from all appropriate sites. Thereafter, PIs may publish results provided the PI submits the proposed publication to Melinta for review at least 60 days prior to the date of the proposed publication. Melinta may remove any information that is considered confidential and/or proprietary. If a publication is not submitted within 12 months of study conclusion, the PI may publish results.