Minocycline Pharmacokinetics (ACUMIN)
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Intervention: Minocycline
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: ACUMIN; Infusion; Injection; Minocycline; Pharmacokinetic; PK

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female > / = 18 years of age.

          2. Subject is in the ICU, or is being admitted to the ICU.

          3. Known or suspected Gram-negative infection for which the subject is receiving systemic
             antibiotics, and which was the reason for admission to the ICU, or reason for
             persistent need for ICU care.

          4. Expectation, in the judgment of the investigator, that the subject will remain
             admitted in the hospital for at least 48 hours following enrollment and that all study
             procedures will be completed.

          5. Expectation that intravenous access will be sufficient for drug infusion and either
             intravenous or arterial access will be sufficient to allow for all protocol required
             blood sampling to occur.

          6. The subject, or legally authorized representative (LAR), is able and willing to
             provide signed informed consent.

        Exclusion Criteria:

          1. History of significant hypersensitivity or allergic reaction to tetracycline
             antibiotics.

          2. Receipt of oral or intravenous tetracycline class drugs within 7 days of enrollment
             (e.g., minocycline, tetracycline, tigecycline, doxycycline).

          3. Use of isotretinoin within 2 weeks of enrollment into the study.

          4. Major surgery* within 48 hours prior to enrollment.

             *Major surgery is defined as "the opening of either a body cavity or the mesenchymal
             barrier, using general anesthesia".

          5. Pregnant or breastfeeding women.

          6. Patient is being treated for intracranial hypertension.

          7. Any condition that, in the judgment of the investigator, precludes participation
             because it could affect subject safety.*

             *Subjects on, or who may be considered for Renal Replacement Therapy (RRT) during the
             study period are not excluded from participating in the study.

          8. Receipt of an investigational study product within 7 days prior to enrollment.
             Investigator discretion should be used when longer acting agents have been used in the
             previous 30 days.