Trial Outcomes & Findings for Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection (NCT NCT02925416)
NCT ID: NCT02925416
Last Updated: 2024-02-01
Results Overview
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. Treatment emergent adverse events (TEAE) were AEs which occurred or whose severities worsened on or after the initiation of study drug. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Up to Day 21 after first administration of oritavancin
Results posted on
2024-02-01
Participant Flow
Participant milestones
| Measure |
Oritavancin/Oritavancin
Participants received an intravenous (IV) infusion of 1200 milligrams (mg) of oritavancin on Day 1 and Day 7
|
Oritavancin/Placebo
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and placebo on Day 7
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
5
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
17
|
5
|
|
Overall Study
COMPLETED
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Oritavancin/Oritavancin
Participants received an intravenous (IV) infusion of 1200 milligrams (mg) of oritavancin on Day 1 and Day 7
|
Oritavancin/Placebo
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and placebo on Day 7
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
Baseline characteristics by cohort
| Measure |
Oritavancin/Oritavancin
n=17 Participants
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and Day 7
|
Oritavancin/Placebo
n=5 Participants
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and placebo on Day 7
|
Total
n=22 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
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21 after first administration of oritavancinPopulation: Safety population included all participants who were dosed with a dose of IV oritavancin
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. Treatment emergent adverse events (TEAE) were AEs which occurred or whose severities worsened on or after the initiation of study drug. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Oritavancin/Oritavancin
n=17 Participants
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and Day 7
|
Oritavancin/Placebo
n=5 Participants
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and placebo on Day 7
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
At least 1 TEAE
|
16 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
At least 1 SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 8 after first administration of oritavancinPopulation: Safety population included all participants who were dosed with a dose of IV oritavancin
Participants were classified by investigator assessment as "success" for clinical response of cure if there was a complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics was needed.
Outcome measures
| Measure |
Oritavancin/Oritavancin
n=17 Participants
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and Day 7
|
Oritavancin/Placebo
n=5 Participants
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and placebo on Day 7
|
|---|---|---|
|
Number of Participants With a Clinical Response of Cure
|
15 Participants
|
5 Participants
|
Adverse Events
Oritavancin/Oritavancin
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Oritavancin/Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oritavancin/Oritavancin
n=17 participants at risk
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and Day 7
|
Oritavancin/Placebo
n=5 participants at risk
Participants received an IV infusion of 1200 mg of oritavancin on Day 1 and placebo on Day 7
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
40.0%
2/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
20.0%
1/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Gastrointestinal disorders
Nausea
|
23.5%
4/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
General disorders
Fatigue
|
11.8%
2/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
40.0%
2/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
General disorders
Chills
|
11.8%
2/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
General disorders
Infusion Site Extravasation
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Infections and infestations
Skin Infection
|
11.8%
2/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
20.0%
1/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
2/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Infections and infestations
Rash Pustular
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Investigations
Blood Pressure Increased
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Investigations
Blood Glucose Increased
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Investigations
Blood Immunoglobulin E Increased
|
0.00%
0/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
20.0%
1/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Investigations
Haemoglobin Decreased
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
20.0%
1/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
20.0%
1/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
20.0%
1/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
20.0%
1/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.8%
2/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
0.00%
0/5 • Up to Day 21 after first administration of oritavancin
Safety population included all participants who were dosed with a dose of IV oritavancin
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER