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

Completed

Conditions studied: Gram-Negative Bacterial Infections

In brief

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

Key facts

Study ID

NCT03160040

Run by

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

People needed

71

Starts

2017-10-11

Expected to finish

2018-05-01

Last updated by the study team

2023-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Infectious Disease and Pulmonary Consultant — Victoria, Texas, United States
• University of Utah Health Sciences Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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