Trial Outcomes & Findings for Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia (NCT NCT02679573)

NCT ID: NCT02679573

Last Updated: 2020-02-27

Results Overview

Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 860 participants
• Primary outcome timeframe: 96 (+/- 24) hours after the first dose of study drug
• Results posted on: 2020-02-27

Participant Flow

860 subjects were planned to be enrolled in the study but 859 are included in the ITT population. One subject mistakenly was randomized into the IXRS but did not provide informed consent; therefore, this subject was not included in the ITT population.

Participant milestones

Measure	Delafloxacin Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Overall Study STARTED	431	428
Overall Study COMPLETED	394	389
Overall Study NOT COMPLETED	37	39

Reasons for withdrawal

Measure	Delafloxacin Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Overall Study Adverse Event	13	6
Overall Study Lack of Efficacy	12	15
Overall Study Could not complete required study visits	6	2
Overall Study Withdrawal by Subject	2	9
Overall Study Death	2	0
Overall Study Physician Decision	2	4
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia

Baseline characteristics by cohort

Measure	Delafloxacin n=431 Participants Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=428 Participants Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses	Total n=859 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	228 Participants n=5 Participants	249 Participants n=7 Participants	477 Participants n=5 Participants
Age, Categorical >=65 years	203 Participants n=5 Participants	179 Participants n=7 Participants	382 Participants n=5 Participants
Age, Continuous	60.7 years STANDARD_DEVIATION 16.06 • n=5 Participants	59.3 years STANDARD_DEVIATION 61.0 • n=7 Participants	60.0 years STANDARD_DEVIATION 16.33 • n=5 Participants
Sex: Female, Male Female	180 Participants n=5 Participants	175 Participants n=7 Participants	355 Participants n=5 Participants
Sex: Female, Male Male	251 Participants n=5 Participants	253 Participants n=7 Participants	504 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	23 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	399 Participants n=5 Participants	405 Participants n=7 Participants	804 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	33 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) White	398 Participants n=5 Participants	388 Participants n=7 Participants	786 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Colombia	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Argentina	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Romania	30 participants n=5 Participants	29 participants n=7 Participants	59 participants n=5 Participants
Region of Enrollment Hungary	14 participants n=5 Participants	12 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Ukraine	84 participants n=5 Participants	84 participants n=7 Participants	168 participants n=5 Participants
Region of Enrollment Russia	38 participants n=5 Participants	42 participants n=7 Participants	80 participants n=5 Participants
Region of Enrollment Spain	10 participants n=5 Participants	14 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment Latvia	19 participants n=5 Participants	21 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Dominican Republic	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Poland	20 participants n=5 Participants	8 participants n=7 Participants	28 participants n=5 Participants
Region of Enrollment South Africa	30 participants n=5 Participants	41 participants n=7 Participants	71 participants n=5 Participants
Region of Enrollment Georgia	45 participants n=5 Participants	50 participants n=7 Participants	95 participants n=5 Participants
Region of Enrollment Slovenia	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Bulgaria	33 participants n=5 Participants	25 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment Serbia	69 participants n=5 Participants	73 participants n=7 Participants	142 participants n=5 Participants
Region of Enrollment Peru	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Germany	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
PORT Risk Class II	54 Participants n=5 Participants	57 Participants n=7 Participants	111 Participants n=5 Participants
PORT Risk Class III	258 Participants n=5 Participants	260 Participants n=7 Participants	518 Participants n=5 Participants
PORT Risk Class IV	115 Participants n=5 Participants	103 Participants n=7 Participants	218 Participants n=5 Participants
PORT Risk Class V	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 96 (+/- 24) hours after the first dose of study drug

Population: ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.

Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline.

Outcome measures

Measure	Delafloxacin n=431 Participants Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=428 Participants Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Early Clinical Response	383 Participants	381 Participants

SECONDARY outcome

Timeframe: 96 (+/- 24) hours after the first dose of study drug

Population: ITT (intent-to-treat) Population is all randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.

Early clinical response with the addition of improvement in vital signs and no worsening of the following 4 symptoms: chest pain, cough, productive sputum, and difficulty breathing in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline. Improvement in vital signs defined as a return to normal of any abnormal vital signs at baseline, and no worsening (ie, be abnormal) of any vital sign that was normal at baseline.

Outcome measures

Measure	Delafloxacin n=431 Participants Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=428 Participants Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Early Clinical Response Plus Improvement in Vital Signs and no Worsening of the 4 Symptoms	227 Participants	184 Participants

SECONDARY outcome

Timeframe: 5 to 10 days after the last dose of study drug

Population: ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.

Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the ITT population.

Outcome measures

Measure	Delafloxacin n=431 Participants Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=428 Participants Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Clinical Outcome at Test of Cure Success	390 Participants	384 Participants
Clinical Outcome at Test of Cure Failure	21 Participants	21 Participants
Clinical Outcome at Test of Cure Indeterminate/Missing	20 Participants	23 Participants

SECONDARY outcome

Timeframe: Up to 24 (+4) hours after the last dose of study drug

Population: ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.

Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the ITT population.

Outcome measures

Measure	Delafloxacin n=431 Participants Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=428 Participants Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Clinical Outcome at End of Treatment Success	396 Participants	390 Participants
Clinical Outcome at End of Treatment Failure	19 Participants	20 Participants
Clinical Outcome at End of Treatment Indeterminate/Missing	16 Participants	18 Participants

SECONDARY outcome

Timeframe: 5 to 10 days after the last dose of study drug

Population: Microbiological ITT 1 (MITT-1) includes all subjects in the ITT population with a baseline bacterial pathogen identified that was known to cause CABP and against which the study drug had antibacterial activity.

Microbiological response for subjects in the MITT set will be based on results of the baseline and follow-up cultures and susceptibility testing or serology.

Outcome measures

Measure	Delafloxacin n=257 Participants Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=263 Participants Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Microbiologic Response	231 Participants	235 Participants

SECONDARY outcome

Timeframe: Day 28 (+/- 2 days)

Population: ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.

Time to all-cause Mortality was assessed on Day 28.

Outcome measures

Measure	Delafloxacin n=431 Participants Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=428 Participants Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
All-cause Mortality	8 Participants	6 Participants

Adverse Events

Delafloxacin

Serious events: 23 serious events

Other events: 40 other events

Deaths: 8 deaths

Moxifloxacin/Linezolid

Serious events: 20 serious events

Other events: 30 other events

Deaths: 6 deaths

Serious adverse events

Measure	Delafloxacin n=429 participants at risk Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=427 participants at risk Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Infections and infestations Pneumonia	0.70% 3/429 • Number of events 3 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Septic Shock	0.70% 3/429 • Number of events 4 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Clostridium difficile colitis	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Herpes zoster meningomyelitis	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Infectious pleural effusion	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Lung abscess	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Sepsis	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Measles	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Oral Herpes	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Infections and infestations Staphylococcal bacteremia	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.47% 2/429 • Number of events 2 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.94% 4/427 • Number of events 4 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Cardiac disorders Cardiomyopathy	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Cardiac disorders Myocardial infarction	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Cardiac disorders Cardiac failure	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.47% 2/427 • Number of events 2 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Cardiac disorders Cardiac failure acute	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.47% 2/427 • Number of events 2 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Immune system disorders Hypersensitivity	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Immune system disorders Sarcoidosis	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Blood and lymphatic system disorders Agranulocytosis	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Vascular disorders Hypertensive crisis	0.23% 1/429 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.00% 0/427 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
General disorders Sudden death	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Nervous system disorders Ischaemic stroke	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Psychiatric disorders Delirium	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/429 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	0.23% 1/427 • Number of events 1 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.

Other adverse events

Measure	Delafloxacin n=429 participants at risk Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total	Moxifloxacin/Linezolid n=427 participants at risk Moxifloxacin: 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total Linezolid: At local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Gastrointestinal disorders Diarrhoea	4.7% 20/429 • Number of events 21 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	3.3% 14/427 • Number of events 14 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Investigations Transaminases increased	3.0% 13/429 • Number of events 13 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	1.4% 6/427 • Number of events 6 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.
Nervous system disorders Headache	1.9% 8/429 • Number of events 8 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.	2.6% 11/427 • Number of events 13 • All adverse events reported or observed during the study will be recorded from the time that the subject is first administered double-blind study drug through the End of Treatment (5 - 10 days) or Test of Cure visit (5 - 10 days after last dose), whichever is later. All serious adverse events will be recorded from the time the subject or authorized representative signs the informed consent form through the Follow up visit (Day 28). Adverse Events are reported in the Safety Population which includes all randomized subjects who received at least 1 dose of study drug. Two subjects in the delafloxacin group and 1 subject in the moxifloxacin group were randomized, but did not receive any study drug.

Additional Information

Sue Cammarata

Melinta Therapeutics, Inc.

Phone: 312-724-9401

Email: scammarata@melinta.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60