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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)

A Phase II, Multi-center, Randomized, Double-blind Study Comparing the Safety and Efficacy of Two Doses of BC-3781 Versus Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01119105
Enrollment
210
Registered
2010-05-07
Start date
2010-05-31
Completion date
2011-02-03
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections, Infection

Keywords

acute bacterial skin and skin structure infection, bacteria

Brief summary

This is a Phase II, multi-center, randomized, double-blind study comparing the safety and efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and skin structure infection.

Detailed description

The purpose of the study is to determine the efficacy of 2 dose regimens of BC-3781 versus the licensed medicinal product vancomycin over 5 to 14 days. The population in this study will be patients with an acute bacterial skin and skin structure infection (ABSSSI) and they will receive treatment with one of two doses of BC-3781 or vancomycin, a standard treatment for this condition.

Interventions

DRUGBC-3781

BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

DRUGVancomycin

Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Sponsors

Nabriva Therapeutics AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or female patients \> 18 * Documented acute bacterial skin and skin structure infection

Exclusion criteria

* Uncomplicated skin and skin structure infection

Design outcomes

Primary

MeasureTime frameDescription
Clinical ResponseTest of Cure (TOC), 7 - 14 days post final treatmentClinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
70
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.
71
Vancomycin
Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
66
Total207

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event101
Overall StudyLost to Follow-up025
Overall StudyOther110
Overall Studystudy drug missed on 2 consecutive days121
Overall StudyWithdrawal by Subject111

Baseline characteristics

CharacteristicBC-3781 Dose 150mgVancomycinBC-3781 Dose 100mgTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants3 Participants4 Participants10 Participants
Age, Categorical
Between 18 and 65 years
68 Participants63 Participants66 Participants197 Participants
Age, Continuous42.2 years
STANDARD_DEVIATION 13.41
40.4 years
STANDARD_DEVIATION 13.7
41.7 years
STANDARD_DEVIATION 13.07
41.4 years
STANDARD_DEVIATION 13.35
Diabetic Status
Diabetic
19 Participants10 Participants14 Participants43 Participants
Diabetic Status
Non-diabetic
52 Participants56 Participants56 Participants164 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants14 Participants11 Participants37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
59 Participants52 Participants59 Participants170 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants0 Participants2 Participants7 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
13 Participants6 Participants9 Participants28 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants2 Participants3 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
51 Participants59 Participants56 Participants166 Participants
Sex: Female, Male
Female
24 Participants27 Participants22 Participants73 Participants
Sex: Female, Male
Male
47 Participants39 Participants48 Participants134 Participants
Smoking Status
Current Smoker
31 Participants32 Participants34 Participants97 Participants
Smoking Status
Non-Smoker
33 Participants23 Participants29 Participants85 Participants
Smoking Status
Past Smoker
7 Participants11 Participants7 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 700 / 710 / 66
other
Total, other adverse events
50 / 7048 / 7149 / 66
serious
Total, serious adverse events
1 / 702 / 712 / 66

Outcome results

Primary

Clinical Response

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

Time frame: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
BC-3781 Dose 100mgClinical ResponseSuccess54 Participants
BC-3781 Dose 100mgClinical ResponseFailure6 Participants
BC-3781 Dose 150mgClinical ResponseFailure6 Participants
BC-3781 Dose 150mgClinical ResponseSuccess48 Participants
VancomycinClinical ResponseFailure4 Participants
VancomycinClinical ResponseSuccess47 Participants
Primary

Clinical Response

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

Time frame: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
BC-3781 Dose 100mgClinical ResponseFailure8 Participants
BC-3781 Dose 100mgClinical ResponseSuccess41 Participants
BC-3781 Dose 100mgClinical ResponseMissing1 Participants
BC-3781 Dose 150mgClinical ResponseFailure6 Participants
BC-3781 Dose 150mgClinical ResponseSuccess42 Participants
BC-3781 Dose 150mgClinical ResponseMissing3 Participants
VancomycinClinical ResponseSuccess42 Participants
VancomycinClinical ResponseMissing3 Participants
VancomycinClinical ResponseFailure6 Participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026