Clinical trial NCT03160040: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-Negative Bacterial Infections
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number Of Participants With Each Gram-negative Bacterial Infection Being Treated With Minocycline IV
timeFrame: Day 1
measure: Infection-related Length Of Stay For Infections Being Treated With Minocycline IV
timeFrame: Up to 30 days after minocycline IV infusion
measure: Number Of Participants With A Microbiologic Response
timeFrame: Up to 30 days after minocycline IV infusion
measure: Duration Of Treatment With Minocycline IV
timeFrame: Day 1 through end of infusion with minocycline
measure: Use Of Concomitant Antibiotics With Minocycline IV
timeFrame: Day 1 through end of infusion with minocycline
measure: Proportion Of Participants With A Clinical Outcome Of Cure, Improved, Or Failure
timeFrame: Up to 30 days after minocycline infusion
measure: Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence
timeFrame: Up to 30 days after minocycline infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Lee Memorial Health System
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Victoria
country: United States
facility: Infectious Disease and Pulmonary Consultant
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: Melinta Therapeutics
name: Medical Information
role: STUDY_DIRECTOR
References: