Gram-Negative Bacterial Infections
Conditions
Brief summary
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
Detailed description
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
Interventions
DRUGMinocycline IV
This study is an observational study. All participants were administered minocycline IV prior to enrollment in this study.
Sponsors
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The participant was treated with Minocin IV for a presumed or culture-confirmed gram-negative infection, as monotherapy or part of a broader regimen, for at least 48 hours. * The participant treatment for gram-negative infection was initiated May 1, 2015, or later. * The participant was at least 18 years old. * This was the first course of Minocin IV administered to the participant within the study period for the treatment of gram-negative infection. * At least 60 days has elapsed since the participant received the last dose of Minocin IV therapy for a presumed or confirmed gram-negative infection (prior to data entry into the electronic case report form, including step-down to oral therapy.
Exclusion criteria
* The participant received Minocin IV as a part of a controlled clinical trial. * The participant received Minocin IV as a part of a Medicines Company- or Rempex Company-sponsored pharmacoeconomic outcomes study. * Pregnancy (in the participant's or participant's partner) occurred after the first dose of Minocin IV through hospital discharge. * Female participants were pregnant or nursing at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Of Participants With Each Gram-negative Bacterial Infection Being Treated With Minocycline IV | Day 1 | The types of primary infections refers to only presumed or documented gram-negative bacterial infections. |
| Infection-related Length Of Stay For Infections Being Treated With Minocycline IV | 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. |
| Number Of Participants With A Microbiologic Response | 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. |
| Duration Of Treatment With Minocycline IV | Day 1 through end of infusion with minocycline | The number of days of treatment with minocycline IV will be presented. |
| Use Of Concomitant Antibiotics With Minocycline IV | 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. |
| Proportion Of Participants With A Clinical Outcome Of Cure, Improved, Or Failure | 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. |
| Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence | 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. |
Countries
United States
Outcome results
None listed