Trial Outcomes & Findings for Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI) (NCT NCT01119105)

NCT ID: NCT01119105

Last Updated: 2020-11-17

Results Overview

Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

210 participants

Primary outcome timeframe

Test of Cure (TOC), 7 - 14 days post final treatment

Results posted on

2020-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	BC-3781 Dose 100mg BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	BC-3781 Dose 150mg BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Vancomycin Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Overall Study STARTED	70	72	68
Overall Study COMPLETED	66	66	60
Overall Study NOT COMPLETED	4	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	BC-3781 Dose 100mg BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	BC-3781 Dose 150mg BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Vancomycin Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Overall Study Withdrawal by Subject	1	1	1
Overall Study Lost to Follow-up	0	2	5
Overall Study Adverse Event	1	0	1
Overall Study study drug missed on 2 consecutive days	1	2	1
Overall Study Other	1	1	0

Baseline Characteristics

Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BC-3781 Dose 100mg n=70 Participants BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	BC-3781 Dose 150mg n=71 Participants BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Vancomycin n=66 Participants Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Total n=207 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=99 Participants	68 Participants n=107 Participants	63 Participants n=206 Participants	197 Participants n=7 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	10 Participants n=7 Participants
Age, Continuous	41.7 years STANDARD_DEVIATION 13.07 • n=99 Participants	42.2 years STANDARD_DEVIATION 13.41 • n=107 Participants	40.4 years STANDARD_DEVIATION 13.70 • n=206 Participants	41.4 years STANDARD_DEVIATION 13.35 • n=7 Participants
Sex: Female, Male Female	22 Participants n=99 Participants	24 Participants n=107 Participants	27 Participants n=206 Participants	73 Participants n=7 Participants
Sex: Female, Male Male	48 Participants n=99 Participants	47 Participants n=107 Participants	39 Participants n=206 Participants	134 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=99 Participants	12 Participants n=107 Participants	14 Participants n=206 Participants	37 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=99 Participants	59 Participants n=107 Participants	52 Participants n=206 Participants	170 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants	5 Participants n=107 Participants	0 Participants n=206 Participants	7 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Race (NIH/OMB) Black or African American	9 Participants n=99 Participants	13 Participants n=107 Participants	6 Participants n=206 Participants	28 Participants n=7 Participants
Race (NIH/OMB) White	56 Participants n=99 Participants	51 Participants n=107 Participants	59 Participants n=206 Participants	166 Participants n=7 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Diabetic Status Diabetic	14 Participants n=99 Participants	19 Participants n=107 Participants	10 Participants n=206 Participants	43 Participants n=7 Participants
Diabetic Status Non-diabetic	56 Participants n=99 Participants	52 Participants n=107 Participants	56 Participants n=206 Participants	164 Participants n=7 Participants
Smoking Status Current Smoker	34 Participants n=99 Participants	31 Participants n=107 Participants	32 Participants n=206 Participants	97 Participants n=7 Participants
Smoking Status Past Smoker	7 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants	25 Participants n=7 Participants
Smoking Status Non-Smoker	29 Participants n=99 Participants	33 Participants n=107 Participants	23 Participants n=206 Participants	85 Participants n=7 Participants

PRIMARY outcome

Timeframe: Test of Cure (TOC), 7 - 14 days post final treatment

Population: Clinically Evaluable Population: A subset of all randomized patients who met additional pre-defined criteria.

Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.

Outcome measures

Outcome measures
Measure	BC-3781 Dose 100mg n=60 Participants BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	BC-3781 Dose 150mg n=54 Participants BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Vancomycin n=51 Participants Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Clinical Response Failure	6 Participants	6 Participants	4 Participants
Clinical Response Success	54 Participants	48 Participants	47 Participants

PRIMARY outcome

Timeframe: Test of Cure (TOC), 7 - 14 days post final treatment

Population: Modified Intent-to-Treat Population: A subset of the Intent-to Treat Population who had a documented Gram-positive pathogen from a blood culture or from a culture of the acute bacterial skin and skin structure infection at baseline.

Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required

Outcome measures

Outcome measures
Measure	BC-3781 Dose 100mg n=50 Participants BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	BC-3781 Dose 150mg n=51 Participants BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Vancomycin n=51 Participants Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Clinical Response Success	41 Participants	42 Participants	42 Participants
Clinical Response Missing	1 Participants	3 Participants	3 Participants
Clinical Response Failure	8 Participants	6 Participants	6 Participants

Adverse Events

BC-3781 Dose 100mg

Serious events: 1 serious events

Other events: 50 other events

Deaths: 0 deaths

BC-3781 Dose 150mg

Serious events: 2 serious events

Other events: 48 other events

Deaths: 0 deaths

Vancomycin

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BC-3781 Dose 100mg n=70 participants at risk BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	BC-3781 Dose 150mg n=71 participants at risk BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Vancomycin n=66 participants at risk Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Infections and infestations Abscess	1.4% 1/70 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	0.00% 0/71 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	0.00% 0/66 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.
Infections and infestations Cellulitis	0.00% 0/70 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	1.4% 1/71 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	0.00% 0/66 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/70 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	0.00% 0/71 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	1.5% 1/66 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.
Nervous system disorders Convulsion	0.00% 0/70 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	0.00% 0/71 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	1.5% 1/66 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/70 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	1.4% 1/71 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.	0.00% 0/66 • Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant. Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.

Other adverse events

Additional Information

Jennifer Schranz, M.D., Chief Medical Officer

Nabriva Therapeutics

Phone: 610-981-2842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All data from the study is confidential information. Sponsor has the right to publish first. Thereafter, PI may publish data from the study, but PI must submit the publication to Sponsor for review at least 60 days prior to publication. Sponsor may remove any confidential and/or proprietary information. If Sponsor's publication is not submitted within 12 months after the study, or if Sponsor decides not to publish, PI may publish the data, subject to Sponsor's rights in the agreement.
Publication restrictions are in place

Restriction type: OTHER