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:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01400867
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 2 months to \< 18 years old.
* Presence of ABSSSI warranting initial hospitalization.
* Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention
Exclusion Criteria:
* Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial
* Uncomplicated skin and soft tissue infections
* More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.
* Requirement for any concomitant systemic antimicrobial therapy
* History of seizures, excluding well-documented febrile seizure of childhood.
* Clinical signs or suspicion of meningitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
17 Years
Study:
NCT01400867
Study Brief:
Protocol Section:
NCT01400867