NCT02961764

Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Completed Phase 4 Results posted Last updated 10 April 2020

What this trial tests

Phase 4 trial testing Usual Care in Acute Bacterial Skin and Skin Structure Infections in 313 participants. Completed in 29 March 2019.

Timeline

29 November 2016

Primary endpoint
29 March 2019

29 March 2019

Quick facts

Lead sponsor	Allergan
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	313
Start date	29 November 2016
Primary completion	29 March 2019
Estimated completion	29 March 2019
Sites	11 locations across United States

Drugs / interventions tested

• Usual Care
• Dalbavancin (DALBAVANCIN) — full drug profile →

Conditions studied

• Acute Bacterial Skin and Skin Structure Infections — all drugs for Acute Bacterial Skin and Skin Structure Infections →

Sponsor

Allergan — full company profile →

Who can join

18 and older, any sex, with Acute Bacterial Skin and Skin Structure Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hospital Admission Rate at Initial Episode of Care Primary · 44 Days

Group	Value	95% CI
Usual Care	60
New Critical Pathway	27
Usual Care	96
New Critical Pathway	126

Number of Total Admitted Hospital Days Secondary · 44 Days

Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations

Group	Value	95% CI
Usual Care	2.3	± 3.74
New Critical Pathway	1.2	± 2.58

Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care Secondary · Initial Care: 14 Days

Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)

Group	Value	95% CI
Usual Care	7.7	± 9.09
New Critical Pathway	6.1	± 3.94

Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time Secondary · 44 Days

Number of all major surgical interventions unexpected or expected that required operating room time

Group	Value	95% CI
Usual Care	107
New Critical Pathway	106
Usual Care	38
New Critical Pathway	35

Number of Infection-related Total Admitted Hospital Days Secondary · 44 Days

Group	Value	95% CI
Usual Care	2.0	± 3.06
New Critical Pathway	1.0	± 2.36

Number of Participants With Infection-related Hospitalizations Secondary · 44 Days

Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations

Group	Value	95% CI
Usual Care	85
New Critical Pathway	110
Usual Care	60
New Critical Pathway	31

Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit Secondary · 44 Days

Group	Value	95% CI
Usual Care	3
New Critical Pathway	0

Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED Secondary · Follow-up: 30 Days

Group	Value	95% CI
Usual Care	7
New Critical Pathway	12

Number of Participants With Infection-related Emergency Department (ED) Visits Secondary · 44 Days

Group	Value	95% CI
Usual Care	22
New Critical Pathway	19

Number of Participants With Infection-related Outpatient Healthcare Visits Secondary · 44 Days

Group	Value	95% CI
Usual Care	57
New Critical Pathway	39

Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy Secondary · 44 Days

Peripheral IV

Group	Value	95% CI
Usual Care	93
New Critical Pathway	141

Central line

Group	Value	95% CI
Usual Care	0
New Critical Pathway	0

PICC line

Group	Value	95% CI
Usual Care	1
New Critical Pathway	1

No Line

Group	Value	95% CI
Usual Care	143
New Critical Pathway	136

Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy Secondary · 44 Days

Group	Value	95% CI
Usual Care	2
New Critical Pathway	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Usual Care

Serious: 11/156 (7%)

Deaths: 2/156

New Critical Pathway

Serious: 16/153 (10%)

Deaths: 2/153

Serious adverse events (26 terms)

Reaction	System	Usual Care	New Critical Pathway
CELLULITIS	Infections and infestations	—	—
SKIN INFECTION	Infections and infestations	—	—
TREATMENT FAILURE	General disorders	—	—
BRONCHITIS	Infections and infestations	—	—
ABSCESS	Infections and infestations	—	—
BACTERAEMIA	Infections and infestations	—	—
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	—	—
LYMPHANGITIS	Infections and infestations	—	—
SKIN BACTERIAL INFECTION	Infections and infestations	—	—
SUBCUTANEOUS ABSCESS	Infections and infestations	—	—
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	—	—
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	—	—
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	—	—
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	—	—
CORONARY ARTERY DISEASE	Cardiac disorders	—	—
ANAPHYLACTIC REACTION	Immune system disorders	—	—
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	—	—
SOFT TISSUE INJURY	Injury, poisoning and procedural complications	—	—
BLOOD CULTURE POSITIVE	Investigations	—	—
CEREBRAL HAEMORRHAGE	Nervous system disorders	—	—
CEREBROVASCULAR ACCIDENT	Nervous system disorders	—	—
ECTOPIC PREGNANCY	Pregnancy, puerperium and perinatal conditions	—	—
DERMATITIS CONTACT	Skin and subcutaneous tissue disorders	—	—
HIDRADENITIS	Skin and subcutaneous tissue disorders	—	—
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Usual Care	New Critical Pathway
Diarrhoea	Gastrointestinal disorders	—	—
Cellulitis	Infections and infestations	—	—

Most-reported serious reactions: CELLULITIS, SKIN INFECTION, TREATMENT FAILURE, BRONCHITIS, ABSCESS, BACTERAEMIA, CLOSTRIDIUM DIFFICILE COLITIS, LYMPHANGITIS.

Data from ClinicalTrials.gov NCT02961764 adverse events section.

Sponsor's own description

This study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections.
   Talan DA, Mower WR, Lovecchio FA, Rothman RE, et al · · 2021 · cited 11× · PMID 33780567 · DOI 10.1111/acem.14258