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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-11

Study Completion Date

2018-05-01

Brief Summary

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

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Detailed Description

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

Conditions

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Gram-Negative Bacterial Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Minocycline IV

Intervention Type DRUG

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

Interventions

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Minocycline IV

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

Intervention Type DRUG

Other Intervention Names

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Minocin®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No