Last updated on September 2020

Minocycline Pharmacokinetics (ACUMIN)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bacterial Infection
  • Age: Between 18 - 99 Years
  • Gender: Male or Female

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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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