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

Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)71 enrolled

Overview

This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gram-Negative Bacterial Infections

Interventions

Minocycline IVDRUG

This study is an observational study. All participants were administered minocycline IV prior to enrollment in this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Lee Memorial Health System

Fort Myers, Florida, United States

Florida Hospital Orlando

Orlando, Florida, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Maimonides Medical Center

Brooklyn, New York, United States

Outcomes

Primary Outcomes

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

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

Time frame: Day 1

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

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.

Time frame: Up to 30 days after minocycline IV infusion

Number Of Participants With A Microbiologic Response

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.

Time frame: Up to 30 days after minocycline IV infusion

Duration Of Treatment With Minocycline IV

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

Time frame: Day 1 through end of infusion with minocycline

Use Of Concomitant Antibiotics With Minocycline IV

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.

Time frame: Day 1 through end of infusion with minocycline

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

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.

Data from ClinicalTrials.gov

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