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)
Sponsor
Nabriva Therapeutics AG (Industry)
Overall Status
Completed
CT.gov ID
NCT01119105
Collaborator
(none)
210
9
3
9.1
23.3
2.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
May 1, 2010
Actual Primary Completion Date
:
Dec 31, 2010
Actual Study Completion Date
:
Feb 3, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BC-3781 dose 100mg
|
Drug: 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.
|
| Experimental: BC-3781 dose 150mg
|
Drug: 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.
|
| Active Comparator: Vancomycin
|
Drug: Vancomycin
Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
|
Outcome Measures
Primary Outcome Measures
- Clinical Response [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 [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BC-3781 Study Center 002 | Chula Vista | California | United States | 91911 |
| 2 | BC-3781 Study Center 001 | La Mesa | California | United States | 91942 |
| 3 | BC-3781 Study Center 003 | Oceanside | California | United States | 92056 |
| 4 | BC-3781 Study Center 012 | Columbus | Georgia | United States | 31904 |
| 5 | BC-3781 Study Center 018 | Savannah | Georgia | United States | 31406 |
| 6 | BC-3781 Study Center 021 | Baton Rouge | Louisiana | United States | 70808 |
| 7 | BC-3781 Study Center 023 | Lafayette | Louisiana | United States | 70503 |
| 8 | BC-3781 Study Center 004 | Butte | Montana | United States | 59701 |
| 9 | BC-3781 Study Center 016 | Somers Point | New Jersey | United States | 08244 |
Sponsors and Collaborators
- Nabriva Therapeutics AG
Investigators
- Study Chair: William T. Prince, Dr., Nabriva Therapeutics AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nabriva Therapeutics AG
ClinicalTrials.gov Identifier:
NCT01119105
Other Study ID Numbers:
- NAB-BC-3781-2001
First Posted:
May 7, 2010
Last Update Posted:
Nov 17, 2020
Last Verified:
Oct 1, 2020
Keywords provided by Nabriva Therapeutics AG
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin |
|---|---|---|---|
| Arm/Group Description | 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: 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 is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| Period Title: Overall Study | |||
| STARTED | 70 | 72 | 68 |
| COMPLETED | 66 | 66 | 60 |
| NOT COMPLETED | 4 | 6 | 8 |
Baseline Characteristics
| Arm/Group Title | BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin | Total |
|---|---|---|---|---|
| Arm/Group Description | 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: 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 is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. | Total of all reporting groups |
| Overall Participants | 70 | 71 | 66 | 207 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
66
94.3%
|
68
95.8%
|
63
95.5%
|
197
95.2%
|
| >=65 years |
4
5.7%
|
3
4.2%
|
3
4.5%
|
10
4.8%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
41.7
(13.07)
|
42.2
(13.41)
|
40.4
(13.70)
|
41.4
(13.35)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
22
31.4%
|
24
33.8%
|
27
40.9%
|
73
35.3%
|
| Male |
48
68.6%
|
47
66.2%
|
39
59.1%
|
134
64.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
11
15.7%
|
12
16.9%
|
14
21.2%
|
37
17.9%
|
| Not Hispanic or Latino |
59
84.3%
|
59
83.1%
|
52
78.8%
|
170
82.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
2
2.9%
|
5
7%
|
0
0%
|
7
3.4%
|
| Asian |
0
0%
|
1
1.4%
|
1
1.5%
|
2
1%
|
| Native Hawaiian or Other Pacific Islander |
2
2.9%
|
1
1.4%
|
0
0%
|
3
1.4%
|
| Black or African American |
9
12.9%
|
13
18.3%
|
6
9.1%
|
28
13.5%
|
| White |
56
80%
|
51
71.8%
|
59
89.4%
|
166
80.2%
|
| More than one race |
1
1.4%
|
0
0%
|
0
0%
|
1
0.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Diabetic Status (Count of Participants) | ||||
| Diabetic |
14
20%
|
19
26.8%
|
10
15.2%
|
43
20.8%
|
| Non-diabetic |
56
80%
|
52
73.2%
|
56
84.8%
|
164
79.2%
|
| Smoking Status (Count of Participants) | ||||
| Current Smoker |
34
48.6%
|
31
43.7%
|
32
48.5%
|
97
46.9%
|
| Past Smoker |
7
10%
|
7
9.9%
|
11
16.7%
|
25
12.1%
|
| Non-Smoker |
29
41.4%
|
33
46.5%
|
23
34.8%
|
85
41.1%
|
Outcome Measures
| Title | Clinical Response |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Clinically Evaluable Population: A subset of all randomized patients who met additional pre-defined criteria. |
| Arm/Group Title | BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin |
|---|---|---|---|
| Arm/Group Description | 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: 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 is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| Measure Participants | 60 | 54 | 51 |
| Success |
54
77.1%
|
48
67.6%
|
47
71.2%
|
| Failure |
6
8.6%
|
6
8.5%
|
4
6.1%
|
| Title | Clinical Response |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin |
|---|---|---|---|
| Arm/Group Description | 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: 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 is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. |
| Measure Participants | 50 | 51 | 51 |
| Success |
41
58.6%
|
42
59.2%
|
42
63.6%
|
| Failure |
8
11.4%
|
6
8.5%
|
6
9.1%
|
| Missing |
1
1.4%
|
3
4.2%
|
3
4.5%
|
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. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin | |||
| Arm/Group Description | 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: 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 is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. | |||
All Cause Mortality |
||||||
| BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/70 (0%) | 0/71 (0%) | 0/66 (0%) | |||
Serious Adverse Events |
||||||
| BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/70 (1.4%) | 2/71 (2.8%) | 2/66 (3%) | |||
| Infections and infestations | ||||||
| Abscess | 1/70 (1.4%) | 0/71 (0%) | 0/66 (0%) | |||
| Cellulitis | 0/70 (0%) | 1/71 (1.4%) | 0/66 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Accidental Overdose | 0/70 (0%) | 0/71 (0%) | 1/66 (1.5%) | |||
| Nervous system disorders | ||||||
| Convulsion | 0/70 (0%) | 0/71 (0%) | 1/66 (1.5%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Respiratory Failure | 0/70 (0%) | 1/71 (1.4%) | 0/66 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 50/70 (71.4%) | 48/71 (67.6%) | 49/66 (74.2%) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 2/70 (2.9%) | 2/71 (2.8%) | 3/66 (4.5%) | |||
| Diarrhoea | 4/70 (5.7%) | 5/71 (7%) | 4/66 (6.1%) | |||
| Nausea | 7/70 (10%) | 7/71 (9.9%) | 11/66 (16.7%) | |||
| Vomiting | 3/70 (4.3%) | 2/71 (2.8%) | 3/66 (4.5%) | |||
| General disorders | ||||||
| Infusion Site Phlebitis | 4/70 (5.7%) | 2/71 (2.8%) | 0/66 (0%) | |||
| Pyrexia | 2/70 (2.9%) | 3/71 (4.2%) | 4/66 (6.1%) | |||
| Infections and infestations | ||||||
| Cellulitis | 3/70 (4.3%) | 4/71 (5.6%) | 0/66 (0%) | |||
| Investigations | ||||||
| Alanine Aminotransferase Increased | 2/70 (2.9%) | 2/71 (2.8%) | 3/66 (4.5%) | |||
| Blood Creatine Phosphokinase Increased | 3/70 (4.3%) | 1/71 (1.4%) | 0/66 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypokalemia | 2/70 (2.9%) | 1/71 (1.4%) | 3/66 (4.5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Pain in Extremity | 3/70 (4.3%) | 0/71 (0%) | 0/66 (0%) | |||
| Nervous system disorders | ||||||
| Dizziness | 2/70 (2.9%) | 1/71 (1.4%) | 3/66 (4.5%) | |||
| Headache | 8/70 (11.4%) | 13/71 (18.3%) | 15/66 (22.7%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 1/70 (1.4%) | 3/71 (4.2%) | 3/66 (4.5%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 2/70 (2.9%) | 0/71 (0%) | 3/66 (4.5%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 3/70 (4.3%) | 2/71 (2.8%) | 9/66 (13.6%) | |||
| Pruritus Generalized | 2/70 (2.9%) | 1/71 (1.4%) | 4/66 (6.1%) | |||
| Rash | 0/70 (0%) | 3/71 (4.2%) | 2/66 (3%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Jennifer Schranz, M.D., Chief Medical Officer |
|---|---|
| Organization | Nabriva Therapeutics |
| Phone | 610-981-2842 |
| jennifer.schranz@nabriva.com |
Responsible Party:
Nabriva Therapeutics AG
ClinicalTrials.gov Identifier:
NCT01119105
Other Study ID Numbers:
- NAB-BC-3781-2001
First Posted:
May 7, 2010
Last Update Posted:
Nov 17, 2020
Last Verified:
Oct 1, 2020