Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT01252732
Eligibility Criteria:
Inclusion Criteria:
Subjects may be included in the study if they meet all of the following inclusion criteria:
1. Males or females ≥18 years old
2. Diagnosis of ABSSSI suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 5 days of IV therapy
3. An ABSSSI includes one of the following infections Wound infections, Cellulitis/erysipelas, Major cutaneous abscess
4. ABSSSI must present with at least 2 signs and symptoms
5. Able to give informed consent and willing to comply with all required study procedures
Exclusion Criteria:
Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
1. Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days
* The causative Gram-positive pathogen(s) isolated from the ABSSSI site is resistant in vitro to the antibacterial(s) that was administered with documented clinical progression, or
* Documented failure to previous ABSSSI antibiotic therapy is available. Documentation of treatment failure must be recorded
* Patient received a single dose of a short acting antibacterial therapy three or more days before randomization
2. Infections associated with, or in close proximity to, a prosthetic device
3. Severe sepsis or refractory shock
4. Known or suspected bacteremia at time of screening
5. ABSSSI due to or associated with any of the following:
* Infections suspected or documented to be caused by Gram-negative pathogens -- Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens
* Diabetic foot infections
* Concomitant infection at another site not including a secondary ABSSSI lesion
* Infected burns
* A primary infection secondary to a pre-existing skin disease with associated inflammatory changes
* Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease
* Any evolving necrotizing process gangrene or infection suspected or proven to be caused by Clostridium species
* Infections known to be caused by a Gram-positive organism with a vancomycin MIC \>2 μg/mL or clinically failing prior therapy with glycopeptides
* Catheter site infections
6. Allergy or intolerance to aztreonam or metronidazole in a patient with suspected or proven polymicrobial wound infection involving Gram-negative and/or anaerobic bacteria
7. Currently receiving chronic systemic immunosuppressive therapy
8. AIDS with CD4 count \< 200 cells/mm3
9. Neutropenia
10. Significant or life-threatening condition that would confound or interfere with the assessment of the ABSSSI
11. Women who are pregnant or nursing
12. History of immune-related hypersensitivity reaction to glycopeptides
13. Patients that require anticoagulant monitoring with an aPTT
14. Contraindication to vancomycin
15. Patients unwilling to forego blood and/or blood product donation
16. Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
17. Investigational device present, or removed \<30 days before enrollment, or presence of device-related infection
18. Patients unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study
19. Severe hepatic disease
20. Presence of hyperuricemia
21. Unwilling to refrain from chronic use of any medication with antipyretic properties
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01252732
Study Brief:
Protocol Section:
NCT01252732