A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF IV AND ORAL DELAFLOXACIN COMPARED WITH VANCOMYCIN + AZTREONAM IN PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

Not Applicable

• Conditions: -L08; L08

• Registration Number: PER-030-14
• Lead Sponsor: Melinta Therapeutics, Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 95

Inclusion Criteria

1. Adult (≥18 years of age) men or women.
2. Patients must have a diagnosis of ABSSSI, ie, an infection involving skin and/or subcutaneous tissues of at least one of the following 4 types: (a) Cellulitis/erysipelas; (b) Wound infection; (c) Major cutaneous abscess; (d) Burn infection
3. Patients must have at least two of the following signs of systemic infection (a) Lymph node enlargement due to the present infection; (b) Documented fever ≥38°C/100.4°F (or the equivalent value for the temperature recording method used); (c) Lymphangitis; (d) Elevated white blood cells of ≥10,000 cells/μL in the 48 hours prior to first dose of study drug; (e) Elevated C-reactive protein (>10 × upper limit of normal [ULN]) in the 48 hours prior to first dose of study drug; (f) Purulent or seropurulent drainage or discharge
4. In the opinion of the investigator, the patient must be a suitable candidate for intravenous (IV) antibiotic therapy.
5. Sexually active women and men with partners of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug.
6. Female partners of male patients should also use an additional reliable method of contraception, such as spermicide with male or female condoms, cervical sponge, intrauterine device, cervical cap or diaphragm, or oral, implantable, transdermal, or injectable contraceptives during study and for 30 days after the final dose of study drug.
7. In the opinion of the investigator, the patient must be able and willing to comply with protocol requirements.
8. A written, voluntarily signed informed consent must be obtained from the patient or legally authorized representative, in accordance with local regulations, before the initiation of any study-related procedures. The patient or legally authorized representative must be able to read and/or understand the informed consent form as required by the legal jurisdiction and the institutional review board/independent ethics committee where the patient is treated.

Exclusion Criteria

1. Medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator.
2. Women who are pregnant or lactating.
3. Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response (eg, atopic dermatitis or eczema). Any other skin condition that, in the opinion of the investigator, would interfere with objective measurement of the ABSSSI under treatment.
4. Infection associated with a prosthetic joint or the removal of a prosthetic joint, or infection involving other prosthetic materials or foreign bodies (eg, catheter tunnels) unless that other prosthetic material will be removed within 24 hours after starting study drug.
5. Infection associated with any of the following: human or animal bite (insect bites are not considered animal bites); osteomyelitis; decubitus ulcer; diabetic foot ulcer; septic
arthritis; mediastinitis; sternal wound; necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis; myositis; tendinitis, endocarditis; toxic shock syndrome; sustained shock (blood pressure <90 mm Hg for >2 hours
despite adequate fluid resuscitation, with evidence of hypoperfusion or use of sympathomimetic agents to maintain blood pressure); gangrene or gas gangrene; burns covering ≥10% of body surface area; severely impaired arterial blood supply to an extremity with an ABSSSI (a patient with a palpable distal pulse or an audible distal pulse by Doppler may be enrolled); current evidence of deep vein thrombosis or superficial thrombophlebitis; and/or any infection types with poor circulatory status in the opinion of the investigator.
6. Minor abscesses, unless present with 1 of the 4 acceptable types of ABSSSI noted in inclusion criteria.
7. Any infection expected to require other systemic antibacterial agents in addition to study drug.
8. Receipt of systemic antibiotic therapy in the 14 days before enrollment unless one of the following is documented:
• The patient received at least 48 hours of antibiotic therapy for ABSSSI AND the clinic notes or photographs document the clinical progression of ABSSSI (ie, not by
patient history alone)
• The patient recently (within 14 days) completed a treatment course with an antibacterial drug for an infection other than ABSSSI and the drug does not have activity
against bacterial pathogens that cause ABSSSI • The patient received only 1 dose of either a single, potentially effective, short-acting (half-life ≤12 hours) antimicrobial drug or a short-acting antimicrobial drug regimen for treatment of the ABSSSI under study before enrollment. (Note: 1 dose of a regimen is defined as the standard therapy for ABSSSI at the study site.)
• Patients who received 1 dose of either a single, potentially effective, short-acting antimicrobial drug or regimen for treatment of the ABSSSI under study in the 14 days before study entry will be limited to no more than 25% of total randomized patients.
9. Anticipated to require either an amputation or multiple debridement procedures.
10. Anticipated that the ABSSSI under treatment will require more than 28 doses of antibiotic therapy.
11. Severely compromised immune systems, eg: • Known absolute neutropenia (absolute neutrophil count <500 cells/μL)
• Known human immunodeficiency virus infection wi

Study & Design

• Study Type: Interventional
• Study Design: Not specified