Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

NCT02127970 | Completed Phase 3 Results DMC

• 1 other identifier: DUR001-303
• Study Type: interventional
• Target: 698
• Locations: 12 countries
• Sites: 78

Brief Summary

To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

Conditions

Abscess; Wound Infection; Surgical Site Infection; Cellulitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug

  Clinical responder was defined as a participant who was alive and had received no rescue therapy for acute bacterial skin and skin structure infection (ABSSSI) prior to the 48-72 hour infection site assessment (if an antibiotic has been given for another reason, the participant will not be considered a non-responder for this reason); and examination of the participant's ABSSSI lesion demonstrates a decrease of ≥ 20% in lesion area (calculated as the longest length multiplied by the longest perpendicular width) relative to the baseline measurement.

  Up to 48-72 hours after the initiation of study drug

Secondary Outcomes (1)

• Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)

  End of Treatment (Day 14-15 after the initiation of study drug) and Final Visit (28 ±2 days after the initiation of study drug)

Other Outcomes (7)

• Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)

  EOT (Day 14-15)

• Percentage of Participants by Investigator Assessment of Clinical Outcome

  Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)

• Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline

  Day 3-4 and EOT (Day 14-15)

Study Arms (2)

Single-Dose Dalbavancin

EXPERIMENTAL

Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.

Drug: Dalbavancin; Drug: Dalbavancin-matching Placebo

Two-Dose Dalbavancin

EXPERIMENTAL

Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.

Drug: Dalbavancin

Interventions

Dalbavancin DRUG

Dalbavancin IV infusion over 30 minutes.

Also known as: DALVANCE®

Single-Dose Dalbavancin; Two-Dose Dalbavancin

Dalbavancin-matching Placebo DRUG

Dalbavancin-matching placebo IV infusion over 30 minutes.

Single-Dose Dalbavancin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants 18 - 85 years of age.
• Signed and dated informed consent document.
• Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
• At least two (2) local signs and symptoms of acute bacterial skin and skin structure infection (ABSSSI and at least one systemic sign of infection.
• Participant willing and able to comply with study procedures.

You may not qualify if:

• A contra-indication to dalbavancin.
• Pregnant or nursing females.
• Sustained shock.
• Participation in another study of an investigational drug or device within 30 days.
• Receipt of a systemically or topically administered antibiotic with a Gram-positive spectrum that achieves therapeutic concentrations in the serum or at the site of the ABSSSI within 14 days prior to randomization. An exception is allowed for participants receiving a single dose of a short-acting (half-life ≤ 12 hours) antibacterial drug prior to randomization; up to 25% of participants may have received such therapy.
• Infection due to an organism known prior to study entry to be resistant to dalbavancin or vancomycin (vancomycin MIC (minimum inhibitory concentration) \>8 μg/mL).
• Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis; endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis.
• Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
• Venous catheter entry site infection.
• Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
• Participant with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, hemodialysis catheter, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, a peritoneal dialysis catheter, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
• Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the participant should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia. Such participants must have an end of treatment (EOT) visit performed within 3 calendar days after discontinuing study medication but are required to have AEs (adverse events) reported through the Final Visit.
• Participants whose ABSSSI is the result of having sustained full or partial thickness burns.
• Participants with an infection involving a limb with evidence of critical ischemia of an affected limb defined as any of the following criteria: absent or abnormal Doppler wave forms, toe blood pressure of \<45 mm Hg, ankle brachial index \<0.5, and/ or critical ischemia as assessed by a vascular surgeon.
• Participants with ABSSSI such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure.

Sponsors & Collaborators

• Durata Therapeutics Inc., an affiliate of Allergan plc: lead

Study Sites (78)

110

Montgomery, Alabama, 36106, United States

Location

103

Anaheim, California, 92804, United States

Location

117

Long Beach, California, 90806, United States

Location

106

Long Beach, California, 90813, United States

Location

118

Modesto, California, 95350, United States

Location

104

San Diego, California, 92120, United States

Location

113

San Diego, California, 92120, United States

Location

115

San Diego, California, 92120, United States

Location

116

San Diego, California, 92120, United States

Location

108

Stockton, California, 95204, United States

Location

105

Sylmar, California, 91342, United States

Location

112

Washington D.C., District of Columbia, 20037, United States

Location

107

Orlando, Florida, 32806, United States

Location

120

Saint Cloud, Florida, 34769, United States

Location

114

Augusta, Georgia, 30909, United States

Location

122

Columbus, Georgia, 31904, United States

Location

125

Savannah, Georgia, 31405, United States

Location

119

Eunice, Louisiana, 70535, United States

Location

101

Springfield, Massachusetts, 01199, United States

Location

109

Detroit, Michigan, 48202, United States

Location

121

Butte, Montana, 59701, United States

Location

123

Omaha, Nebraska, 68131, United States

Location

111

Toledo, Ohio, 43608, United States

Location

126

Franklin, Tennessee, 37064, United States

Location

127

Smyrna, Tennessee, 37167, United States

Location

802

Sofia, 1000, Bulgaria

Location

800

Sofia, 1431, Bulgaria

Location

801

Sofia, 1606, Bulgaria

Location

200

Zagreb, 10000, Croatia

Location

201

Zagreb, 10000, Croatia

Location

253

Tallinn, 10318, Estonia

Location

252

Tallinn, 13419, Estonia

Location

251

Tartu, 51014, Estonia

Location

302

Kutaisi, 4600, Georgia

Location

303

Tbilisi, 0144, Georgia

Location

300

Tbilisi, 0160, Georgia

Location

301

Tbilisi, 0160, Georgia

Location

352

Debrecen, 4012, Hungary

Location

353

Kaposvár, 7400, Hungary

Location

354

Pécs, 7632, Hungary

Location

351

Szeged, 6720, Hungary

Location

402

Daugavpils, LV-5417, Latvia

Location

401

Liepāja, LV-3414, Latvia

Location

403

Rēzekne, LV-4601, Latvia

Location

400

Riga, LV-1002, Latvia

Location

404

Riga, LV-1038, Latvia

Location

501

Cluj-Napoca, Cluj, 400006, Romania

Location

502

Bucharest, 030303, Romania

Location

500

Bucharest, 041915, Romania

Location

503

Bucharest, 42122, Romania

Location

555

Vsevolozhsk, Leningradskaya Oblast', 188643, Russia

Location

557

Irkutsk, 664079, Russia

Location

552

Moscow, 111539, Russia

Location

554

Moscow, 111539, Russia

Location

553

Novosibirsk, 630051, Russia

Location

551

Saint Petersburg, 198099, Russia

Location

556

Tomsk, 634063, Russia

Location

600

Belgrade, 11000, Serbia

Location

601

Belgrade, 11000, Serbia

Location

603

Niš, 18000, Serbia

Location

602

Novi Sad, 21000, Serbia

Location

756

Breyten, 2330, South Africa

Location

760

Cape Town, 7530, South Africa

Location

752

Dundee, 3000, South Africa

Location

755

Johannesburg, 2113, South Africa

Location

751

Middleburg, 1055, South Africa

Location

758

Port Elizabeth, 6014, South Africa

Location

757

Pretoria, 0040, South Africa

Location

753

Pretoria, 0084, South Africa

Location

759

Pretoria, 0183, South Africa

Location

754

Worcester, 6850, South Africa

Location

700

Cherkasy, 18009, Ukraine

Location

704

Dnipropetrovsk, 49005, Ukraine

Location

706

Ivano-Frankivsk, 76012, Ukraine

Location

701

Ivano-Frankivsk, 76025, Ukraine

Location

705

Kharkiv, 61037, Ukraine

Location

703

Lviv, 79059, Ukraine

Location

702

Zaporizhzhya, 69032, Ukraine

Location

Related Publications (3)

• Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14.

  PMID: 34905144 DERIVED

• Rappo U, Gonzalez PL, Puttagunta S, Akinapelli K, Keyloun K, Gillard P, Liu Y, Dunne MW. Single-dose dalbavancin and patient satisfaction in an outpatient setting in the treatment of acute bacterial skin and skin structure infections. J Glob Antimicrob Resist. 2019 Jun;17:60-65. doi: 10.1016/j.jgar.2019.02.007. Epub 2019 Feb 20.

  PMID: 30797084 DERIVED

• Dunne MW, Puttagunta S, Giordano P, Krievins D, Zelasky M, Baldassarre J. A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection. Clin Infect Dis. 2016 Mar 1;62(5):545-51. doi: 10.1093/cid/civ982. Epub 2015 Nov 26.

  PMID: 26611777 DERIVED

MeSH Terms

Conditions

Abscess; Wound Infection; Surgical Wound Infection; Cellulitis

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Skin Diseases, Infectious; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Urania Rappo, MD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: May 1, 2014
• Study Start: April 18, 2014
• Primary Completion: March 11, 2015
• Study Completion: March 11, 2015
• Last Updated: September 28, 2018
• Results First Posted: August 14, 2018

Record last verified: 2018-08

Locations

GE (4); LA (5); ZA (10); BU (3); SE (4); HU (4); US (25); RO (4); RU (7); ES (3); CR (2); UA (7)