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

Retrospective, Observational Evaluation of the Utilization, Outcomes, and Adverse Events Associated With Minocin IV for the Treatment of Infections Presumed or Confirmed to be Caused by Gram-negative Bacteria in a Real World Setting

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

Study Overview

• Status: Completed
• Conditions: Gram-Negative Bacterial Infections
• Intervention / Treatment: Drug: Minocycline IV

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Lee Memorial Health System
    • Orlando, Florida, United States, 32803
      • Florida Hospital Orlando
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
  • Texas
    • Victoria, Texas, United States, 77901
      • Infectious Disease and Pulmonary Consultant
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants in intensive care unit (ICU) and non-ICU real world settings throughout the United States, who received at least 48 hours of minocycline IV in the treatment of documented gram-negative infections.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Minocycline IV; Participants who received 2 doses over 48 hours if given once daily or 4 doses over 48 hours if given twice daily of minocycline intravenous (IV) as monotherapy, with or without transition to oral minocycline.	Drug: Minocycline IV; This study is an observational study. All participants were administered minocycline IV prior to enrollment in this study.; Other Names: Minocin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Up to 30 days after minocycline infusion
Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence	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.	Up to 30 days after minocycline infusion

Collaborators and Investigators

• Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
• Investigators: Study Director: Medical Information, Melinta Therapeutics

Publications and helpful links

Helpful Links

• Minocycline Intravenous for the Treatment of Serious Infections Due to Gram-Negative Nonpseudomonal Bacteria, Including Stenotrophomonas maltophilia, Acinetobacter baumannii, and Burkholderia cepacia

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections; Gram-Negative Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: MDCO-MIN-16-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Package Insert
   Information identifier: MINOCIN® (minocycline)
   Information comments: MINOCIN® (minocycline) for Injection 100 mg/vial. United States Prescribing Information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No