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

NCT ID: NCT02127970

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 698 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-18
• Study Completion Date: 2015-03-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single-Dose Dalbavancin

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.

Group Type: EXPERIMENTAL

Dalbavancin

Intervention Type: DRUG

Dalbavancin IV infusion over 30 minutes.

Dalbavancin-matching Placebo

Intervention Type: DRUG

Dalbavancin-matching placebo IV infusion over 30 minutes.

Two-Dose Dalbavancin

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.

Group Type: EXPERIMENTAL

Dalbavancin

Intervention Type: DRUG

Dalbavancin IV infusion over 30 minutes.

Interventions

Dalbavancin

Dalbavancin IV infusion over 30 minutes.

Intervention Type: DRUG

Dalbavancin-matching Placebo

Dalbavancin-matching placebo IV infusion over 30 minutes.

Intervention Type: DRUG

Other Intervention Names

DALVANCE®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
• Anticipated need of antibiotic therapy for longer than 14 days.
• Participants who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
• More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the ABSSSI, or participants who are expected to require more than 2 such interventions.
• Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
• Absolute neutrophil count <500 cells/mm^3.
• Known or suspected human immunodeficiency virus (HIV) infected participants with a CD4 (cluster of differentiation 4) cell count <200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.
• Participants with a recent bone marrow transplant (in post-transplant hospital stay).
• Participants receiving oral steroids >20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
• Participants with a rapidly fatal illness, who are not expected to survive for 3 months.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participants inappropriate for entry into this study.
• Prior participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Durata Therapeutics Inc., an affiliate of Allergan plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urania Rappo, MD

Role: STUDY_DIRECTOR

Allergan

Locations

110

Montgomery, Alabama, United States

103

Anaheim, California, United States

117

Long Beach, California, United States

106

Long Beach, California, United States

118

Modesto, California, United States

104

San Diego, California, United States

113

San Diego, California, United States

115

San Diego, California, United States

116

San Diego, California, United States

108

Stockton, California, United States

105

Sylmar, California, United States

112

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

107

Orlando, Florida, United States

120

Saint Cloud, Florida, United States

114

Augusta, Georgia, United States

122

Columbus, Georgia, United States

125

Savannah, Georgia, United States

119

Eunice, Louisiana, United States

101

Springfield, Massachusetts, United States

109

Detroit, Michigan, United States

121

Butte, Montana, United States

123

Omaha, Nebraska, United States

111

Toledo, Ohio, United States

126

Franklin, Tennessee, United States

127

Smyrna, Tennessee, United States

802

Sofia, , Bulgaria

800

Sofia, , Bulgaria

801

Sofia, , Bulgaria

200

Zagreb, , Croatia

201

Zagreb, , Croatia

253

Tallinn, , Estonia

252

Tallinn, , Estonia

251

Tartu, , Estonia

302

Kutaisi, , Georgia

303

Tbilisi, , Georgia

300

Tbilisi, , Georgia

301

Tbilisi, , Georgia

352

Debrecen, , Hungary

353

Kaposvár, , Hungary

354

Pécs, , Hungary

351

Szeged, , Hungary

402

Daugavpils, , Latvia

401

Liepāja, , Latvia

403

Rēzekne, , Latvia

400

Riga, , Latvia

404

Riga, , Latvia

501

Cluj-Napoca, Cluj, Romania

502

Bucharest, , Romania

500

Bucharest, , Romania

503

Bucharest, , Romania

555

Vsevolozhsk, Leningradskaya Oblast', Russia

557

Irkutsk, , Russia

552

Moscow, , Russia

554

Moscow, , Russia

553

Novosibirsk, , Russia

551

Saint Petersburg, , Russia

556

Tomsk, , Russia

600

Belgrade, , Serbia

601

Belgrade, , Serbia

603

Niš, , Serbia

602

Novi Sad, , Serbia

756

Breyten, , South Africa

760

Cape Town, , South Africa

752

Dundee, , South Africa

755

Johannesburg, , South Africa

751

Middleburg, , South Africa

758

Port Elizabeth, , South Africa

757

Pretoria, , South Africa

753

Pretoria, , South Africa

759

Pretoria, , South Africa

754

Worcester, , South Africa

700

Cherkasy, , Ukraine

704

Dnipropetrovsk, , Ukraine

706

Ivano-Frankivsk, , Ukraine

701

Ivano-Frankivsk, , Ukraine

705

Kharkiv, , Ukraine

703

Lviv, , Ukraine

702

Zaporizhzhya, , Ukraine

Countries

United States; Bulgaria; Croatia; Estonia; Georgia; Hungary; Latvia; Romania; Russia; Serbia; South Africa; Ukraine

References

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.

Reference Type: DERIVED

PMID: 34905144 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30797084 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26611777 (View on PubMed)

Other Identifiers

DUR001-303

Identifier Type: -

Identifier Source: org_study_id