Minocycline Pharmacokinetics (ACUMIN)
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase IV, multi-center open-label pharmacokinetic trial studying the
      pharmacokinetics and pharmacodynamics of a single dose of Minocin IV. Up to 67 subjects will
      be enrolled to obtain 50 evaluable, ICU patients who are already receiving antimicrobial
      therapy for a known or suspected Gram-negative infection. The entire study duration will be
      approximately 16 months and each subject participation duration will be approximately 2 days.
      The study will be conducted at approximately 13 clinical sites. Each subject will receive a
      single 200 mg dose of Minocin IV infused over approximately 60 minutes. Each subject will
      have 7 PK samples collected (1 pre-dose, 6 post-dose) at designated time points over a ~48
      hour period following the start of the Minocin IV infusion. The primary objectives are: 1) To
      characterize minocycline PK at the population level in critically-ill adults, with illness
      known or suspected to be caused by infection with Gram-negative bacteria and 2) To assess
      patient-level and clinical covariates associated with minocycline pharmacokinetic properties
      in critically-ill adults, with illness known or suspected to be caused by infection with
      Gram-negative bacteria.
    

Detailed description: 
      This is a Phase IV, multi-center open-label pharmacokinetic trial studying the
      pharmacokinetics and pharmacodynamics of a single dose of Minocin IV. Up to 67 subjects will
      be enrolled to obtain 50 evaluable, ICU patients who are already receiving antimicrobial
      therapy for a known or suspected Gram-negative infection. The entire study duration will be
      approximately 16 months and each subject participation duration will be approximately 2 days.
      The study will be conducted at approximately 13 clinical sites. Each subject will receive a
      single 200 mg dose of Minocin IV infused over approximately 60 minutes. Each subject will
      have 7 PK samples collected (1 pre-dose, 6 post-dose) at designated time points over a ~48
      hour period following the start of the Minocin IV infusion. The primary objectives are: 1) To
      characterize minocycline PK at the population level in critically-ill adults, with illness
      known or suspected to be caused by infection with Gram-negative bacteria and 2) To assess
      patient-level and clinical covariates associated with minocycline pharmacokinetic properties
      in critically-ill adults, with illness known or suspected to be caused by infection with
      Gram-negative bacteria. Up to 67 subjects will be enrolled in order to obtain 50 PK evaluable
      subjects in the study. To be considered PK evaluable, a subject must receive the full
      infusion of study drug, and is required to have at least 3 PK samples collected in the first
      12 hours post dose and at least 1 PK sample collected 24-48 hours post dose. Subjects who are
      dosed with minocycline but do not meet this PK sampling requirement will still be included in
      the population PK analysis, but an additional subject will be enrolled as a replacement to
      meet the goal of having 50 PK evaluable subjects with intensive PK sampling.
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): Minocycline is a semisynthetic derivative of tetracycline and is indicated for the treatment of infections due to susceptible isolates of designated microorganisms.
Intervention MeSH terms: Minocycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACUMIN; Infusion; Injection; Minocycline; Pharmacokinetic; PK