Trial Outcomes & Findings for Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections (NCT NCT00719810)

NCT ID: NCT00719810

Last Updated: 2014-07-14

Results Overview

A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

14-21 days after the last dose of study drug

Results posted on

2014-07-14

Participant Flow

This study targeted participants with complicated skin and skin structure infections (cSSSI), i.e. infections involving subcutaneous tissues or requiring surgical intervention. Patients could have one of three infection types: wound infection, abscess, or cellulitis.

Participant milestones

Participant milestones
Measure	Delafloxacin 300 mg IV q12h	Delafloxacin 450 mg IV q12h	Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h
Overall Study STARTED	49	51	50
Overall Study COMPLETED	46	47	42
Overall Study NOT COMPLETED	3	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Delafloxacin 300 mg IV q12h	Delafloxacin 450 mg IV q12h	Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h
Overall Study Adverse Event	0	2	3
Overall Study Lost to Follow-up	2	0	3
Overall Study Physician Decision	0	1	0
Overall Study Withdrawal by Subject	1	1	2

Baseline Characteristics

Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delafloxacin 300 mg IV q12h n=49 Participants	Delafloxacin 450 mg IV q12h n=51 Participants	Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h n=50 Participants	Total n=150 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 15.10 • n=99 Participants	37.2 years STANDARD_DEVIATION 14.35 • n=107 Participants	40.4 years STANDARD_DEVIATION 13.83 • n=206 Participants	40.1 years STANDARD_DEVIATION 14.51 • n=7 Participants
Sex: Female, Male Female	18 Participants n=99 Participants	15 Participants n=107 Participants	15 Participants n=206 Participants	48 Participants n=7 Participants
Sex: Female, Male Male	31 Participants n=99 Participants	36 Participants n=107 Participants	35 Participants n=206 Participants	102 Participants n=7 Participants

PRIMARY outcome

Timeframe: 14-21 days after the last dose of study drug

Population: The CE population included patients with a diagnosis of cSSSI who received at least 80% of study drug, had a test of cure (TOC) visit 14-21 days after the last dose of study drug, and who did not receive any concomitant, systemic antibacterial therapy with activity against the causative pathogen.

Outcome measures

Outcome measures
Measure	Delafloxacin 300 mg IV q12h n=35 Participants	Delafloxacin 450 mg IV q12h n=40 Participants	Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h n=34 Participants
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population	33 Participants	37 Participants	31 Participants

SECONDARY outcome

Timeframe: 14-21 days after the last dose of study drug

Population: Clinically Evaluable (CE) patients (see previous definition) with MRSA isolated from screening culture of primary infection.

Outcome measures

Outcome measures
Measure	Delafloxacin 300 mg IV q12h n=14 Participants	Delafloxacin 450 mg IV q12h n=20 Participants	Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h n=14 Participants
Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)	13 Participants	19 Participants	12 Participants

Adverse Events

Delafloxacin 300 mg IV q12h

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Delafloxacin 450 mg IV q12h

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Delafloxacin 300 mg IV q12h n=49 participants at risk	Delafloxacin 450 mg IV q12h n=51 participants at risk	Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h n=50 participants at risk
Cardiac disorders Bradycardia	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	2.0% 1/51 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/50 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Infections and infestations Cellulitis	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/51 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	2.0% 1/50 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Nervous system disorders Cerebellar infarction	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/51 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	2.0% 1/50 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Nervous system disorders Convulsion	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	2.0% 1/51 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/50 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Gastrointestinal disorders Duodenal ulcer hemorrhage	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/51 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	2.0% 1/50 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Injury, poisoning and procedural complications Femoral neck fracture	2.0% 1/49 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/51 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/50 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Infections and infestations Osteomyelitis	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	2.0% 1/51 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/50 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Vascular disorders Subclavian vein thrombosis	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/51 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	2.0% 1/50 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).

Other adverse events

Other adverse events
Measure	Delafloxacin 300 mg IV q12h n=49 participants at risk	Delafloxacin 450 mg IV q12h n=51 participants at risk	Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h n=50 participants at risk
Investigations Alanine aminotransferase increased	6.1% 3/49 • Number of events 3 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/51 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/50 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Gastrointestinal disorders Constipation	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/51 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	8.0% 4/50 • Number of events 4 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Gastrointestinal disorders Diarrhea	10.2% 5/49 • Number of events 5 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	23.5% 12/51 • Number of events 12 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	10.0% 5/50 • Number of events 5 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Nervous system disorders Dizziness	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	2.0% 1/51 • Number of events 1 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	8.0% 4/50 • Number of events 4 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
General disorders Fatigue	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	7.8% 4/51 • Number of events 4 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/50 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Nervous system disorders Headache	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	7.8% 4/51 • Number of events 4 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	12.0% 6/50 • Number of events 6 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
General disorders Infusion site pain	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	13.7% 7/51 • Number of events 7 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/50 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Gastrointestinal disorders Nausea	12.2% 6/49 • Number of events 6 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	25.5% 13/51 • Number of events 13 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	46.0% 23/50 • Number of events 23 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Skin and subcutaneous tissue disorders Rash	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	3.9% 2/51 • Number of events 2 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	6.0% 3/50 • Number of events 3 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/51 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	6.0% 3/50 • Number of events 3 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Infections and infestations Subcutaneous abscess	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	7.8% 4/51 • Number of events 4 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	0.00% 0/50 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).
Gastrointestinal disorders Vomiting	0.00% 0/49 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	11.8% 6/51 • Number of events 6 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).	28.0% 14/50 • Number of events 14 • All adverse events (AEs) that occurred from the time the patient signed the informed consent form (ICF) were to be reported on the appropriate electronic case report form (eCRF).

Additional Information

Eugene Sun, M.D.

Melinta Therapeutics

Phone: 203.624.5606

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor retains control of all publication rights.
Publication restrictions are in place

Restriction type: OTHER