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

NCT03160040 | Completed FDA Drug

• 1 other identifier: MDCO-MIN-16-05
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Gram-Negative Bacterial Infections

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

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

Interventions

Minocycline IV DRUG

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

Also known as: Minocin®

Minocycline IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.): lead

Study Sites (6)

Lee Memorial Health System

Fort Myers, Florida, 33901, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Infectious Disease and Pulmonary Consultant

Victoria, Texas, 77901, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Related Links

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

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Medical Information

  Melinta Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: October 11, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)