Bacterial InfectionsPhase 2NCT01119105

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 2 study testing BC-3781 and Vancomycin in people with Bacterial Infections and Infection, run by Nabriva Therapeutics AG at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bacterial Infections, Infection
What is being tested?: BC-3781 and Vancomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 9 sitesUnited States
Study dates: May 2010to 3 Feb 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Uncomplicated skin and skin structure infection

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

BC-3781 Study Center 021
Baton Rouge, Louisiana, 70808
BC-3781 Study Center 004
Butte, Montana, 59701
BC-3781 Study Center 002
Chula Vista, California, 91911
BC-3781 Study Center 012
Columbus, Georgia, 31904
BC-3781 Study Center 001
La Mesa, California, 91942
BC-3781 Study Center 023
Lafayette, Louisiana, 70503
BC-3781 Study Center 003
Oceanside, California, 92056
BC-3781 Study Center 018
Savannah, Georgia, 31406
BC-3781 Study Center 016
Somers Point, New Jersey, 08244

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Bacterial Infections, Infection
Being tested: BC-3781, Vancomycin
Keywords: acute bacterial skin and skin structure infection, bacteria
Medical subject headings: Bacterial Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BC-3781Drug
BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
BC-3781Drug
BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
VancomycinDrug
Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Study groups in NCT01119105
Study group	Role	What they receive
BC-3781 dose 100mg	Experimental	Not described Receives: Drug: BC-3781
BC-3781 dose 150mg	Experimental	Not described Receives: Drug: BC-3781
Vancomycin	Active comparator	Not described Receives: Drug: Vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 20103 Feb 2011

First posted7 May 2010 (estimated)
Study startMay 2010
Primary completion31 Dec 2010
Study completion3 Feb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01119105
Sponsor's protocol ID: NAB-BC-3781-2001
Status last verified: Oct 2020
First submitted: 5 May 2010
Last updated: 17 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rubino CM, Xue B, Bhavnani SM, Prince WT, Ivezic-Schoenfeld Z, Wicha WW, Ambrose PG. Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Jan;59(1):282-8. doi: 10.1128/AAC.02033-13. Epub 2014 Oct 27.
PubMed 25348519

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01119105
Acronym / sponsor ID: NAB-BC-3781-2001
Conditions: Bacterial Infections, Infection
Keywords: acute bacterial skin and skin structure infection, bacteria
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: Nabriva Therapeutics AGIndustry (pharma, biotech, devices)
Study start: May 2010 (actual)
Primary completion: 31 Dec 2010 (actual)
Study completion: 3 Feb 2011 (actual)
First posted: 7 May 2010 (estimated)
Results: Posted 27 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BC-3781 dose 100mg	Experimental	Drug: BC-3781
BC-3781 dose 150mg	Experimental	Drug: BC-3781
Vancomycin	Active comparator	Drug: Vancomycin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Uncomplicated skin and skin structure infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BC-3781BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Drug	BC-3781 dose 100mg
BC-3781BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Drug	BC-3781 dose 150mg
VancomycinVancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.	Drug	Vancomycin

Primary outcome

Clinical Response
Time frame: Test of Cure (TOC), 7 - 14 days post final treatment
Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.
Clinical Response
Time frame: Test of Cure (TOC), 7 - 14 days post final treatment
Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required

Results and safety

Results posted to the registry on 27 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BC-3781 Dose 100mg	70	66
BC-3781 Dose 150mg	72	66
Vancomycin	68	60

Primary outcome: Clinical Response

Time frame: Test of Cure (TOC), 7 - 14 days post final treatment. Count of participants. Unit: Participants

Measure	BC-3781 Dose 100mg n = 60	BC-3781 Dose 150mg n = 54	Vancomycin n = 51
Success	54	48	47
Failure	6	6	4

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

Primary outcome: Clinical Response

Time frame: Test of Cure (TOC), 7 - 14 days post final treatment. Count of participants. Unit: Participants

Measure	BC-3781 Dose 100mg n = 50	BC-3781 Dose 150mg n = 51	Vancomycin n = 51
Success	41	42	42
Failure	8	6	6
Missing	1	3	3

Population analysed: 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.

Adverse events

Time frame: 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.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BC-3781 Dose 100mg	1 of 70 (1.4%)	50 of 70 (71.4%)	0 of 70
BC-3781 Dose 150mg	2 of 71 (2.8%)	48 of 71 (67.6%)	0 of 71
Vancomycin	2 of 66 (3%)	49 of 66 (74.2%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25348519Rubino CM, Xue B, Bhavnani SM, Prince WT, Ivezic-Schoenfeld Z, Wicha WW, Ambrose PG. Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Jan;59(1):282-8. doi: 10.1128/AAC.02033-13. Epub 2014 Oct 27.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William T. Prince, Dr. study chair

Nabriva Therapeutics AG

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BC-3781 and Vancomycin in people with Bacterial Infections and Infection, run by Nabriva Therapeutics AG at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response (time frame: Test of Cure (TOC), 7 - 14 days post final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01119105, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.