A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Minocin® (Minocycline) for Infections Caused by Gram-negative Bacteria in a Real World Setting

Primary outcomes

1. Number Of Participants With Each Gram-negative Bacterial Infection Being Treated With Minocycline IV

   Time frame: Day 1

   The types of primary infections refers to only presumed or documented gram-negative bacterial infections.

2. Infection-related Length Of Stay For Infections Being Treated With Minocycline IV

   Time frame: Up to 30 days after minocycline IV infusion

   Data will be collected to include infection-related length of stay , which is defined as the difference between the day of initiation of antimicrobial administration for the primary infection and day of discontinuation, death, or discharge date, whichever is sooner. This may include minocycline IV or other empiric antimicrobial regimen.

3. Number Of Participants With A Microbiologic Response

   Time frame: Up to 30 days after minocycline IV infusion

   The number of participants with a gram-negative pathogen for which minocycline IV is used for treatment of the primary infection site(s) and the number of participants with a gram-positive pathogen recovered from a secondary infection site or from a mixed culture also containing the targeted gram-negative pathogen will be presented.

4. Duration Of Treatment With Minocycline IV

   Time frame: Day 1 through end of infusion with minocycline

   The number of days of treatment with minocycline IV will be presented.

5. Use Of Concomitant Antibiotics With Minocycline IV

   Time frame: Day 1 through end of infusion with minocycline

   Concomitant antibiotics include those used between the first and last dose of minocycline IV. The number of participants and the type of antibiotic taken will be presented.

6. Proportion Of Participants With A Clinical Outcome Of Cure, Improved, Or Failure

   Time frame: Up to 30 days after minocycline infusion

   Clinical assessments will be based on participant records between end of infusion to 30 days following the last dose of minocycline (includes minocycline IV plus oral minocycline). Clinical categories for assessment include:

   • Cure: Clinical signs and symptoms are resolved and no additional antibiotic therapy is necessary for the treatment of the infection
   • Improved: Partial resolution of clinical signs and symptoms and no additional antibiotic therapy is necessary for the treatment of the infection
   • Failure: Inadequate resolution, or new or worsening clinical signs and symptoms, such that additional antibiotic therapy is necessary for treatment of the infection
   • Non-evaluable: Unable to determine response because the participant record did not contain the necessary information to determine cure, improvement, or failure.

7. Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence

   Time frame: Up to 30 days after minocycline infusion

   Microbiological assessments will be based on participant records between end of infusion to 30 days following the last dose of minocycline (includes minocycline IV plus oral minocycline). Microbiological categories will include only gram-negative pathogens believed to be related to the primary infection and are defined as:

   • Eradication: Documentation of a negative bacterial culture from the same site as the initial positive baseline culture
   • Presumed eradication: The absence of follow-up microbiological data/information in a participant with a clinical response of cure or improved
   • Persistence: Bacterial growth from the same site as the initial positive baseline culture excluding colonization; also referred to as microbiologic failure.