Clinical trial

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

Name

MDCO-MIN-16-05

Description

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

Trial arms

Trial start

2017-10-11

Estimated PCD

2018-05-01

Trial end

2018-05-01

Status

Completed

Treatment

Minocycline IV

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

Arms:

Minocycline IV

Other names:

Minocin®

Size

Primary endpoint

Number Of Participants With Each Gram-negative Bacterial Infection Being Treated With Minocycline IV

Day 1

Infection-related Length Of Stay For Infections Being Treated With Minocycline IV

Up to 30 days after minocycline IV infusion

Number Of Participants With A Microbiologic Response

Up to 30 days after minocycline IV infusion

Duration Of Treatment With Minocycline IV

Day 1 through end of infusion with minocycline

Use Of Concomitant Antibiotics With Minocycline IV

Day 1 through end of infusion with minocycline

Proportion Of Participants With A Clinical Outcome Of Cure, Improved, Or Failure

Up to 30 days after minocycline infusion

Proportion Of Participants With A Microbiologic Eradication Or Microbiologic Persistence

Up to 30 days after minocycline infusion

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 71, 'type': 'ACTUAL'}}

Updated at

2023-08-28

1 organization

1 product

1 indication

Organization

Melinta Therapeutics

Product

Minocycline

Indication

Gram-Negative Bacterial Infections