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

Rempex Pharmaceuticals

Status: Completed

Conditions: Gram-Negative Bacterial Infections

Treatments: Drug: Minocycline IV

Study type: Observational

Funder types: Industry

Identifiers

NCT03160040

MDCO-MIN-16-05

Details and patient eligibility

About

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

Full description

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

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

71 participants in 1 patient group

Minocycline IV

Description:

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.

Treatment:

Drug: Minocycline IV