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

Gram-Negative Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160040
• Other study ID #: MDCO-MIN-16-05
• Status: Completed
• Start date: October 11, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2023
• Source: Melinta Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Gram-Negative Bacterial Infections
• Infections

Intervention

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

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York
United States	Lee Memorial Health System	Fort Myers	Florida
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Florida Hospital Orlando	Orlando	Florida
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Infectious Disease and Pulmonary Consultant	Victoria	Texas

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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