Minocycline Pharmacokinetics (ACUMIN)

Completed · Phase 4

Conditions studied: Bacterial Infection

In brief

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.

Key facts

Study ID

NCT03369951

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

58

Starts

2018-03-28

Expected to finish

2019-07-20

Last updated by the study team

2020-12-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female > / = 18 years of age.
• Subject is in the ICU, or is being admitted to the ICU.
• 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.
• 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.
• 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.
• The subject, or legally authorized representative (LAR), is able and willing to provide signed informed consent.

You may not qualify if…

• History of significant hypersensitivity or allergic reaction to tetracycline antibiotics.
• Receipt of oral or intravenous tetracycline class drugs within 7 days of enrollment (e.g., minocycline, tetracycline, tigecycline, doxycycline).
• Use of isotretinoin within 2 weeks of enrollment into the study.
• 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".
• Pregnant or breastfeeding women.
• Patient is being treated for intracranial hypertension.
• 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.
• 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.

Where it is running

• Emory Decatur Hospital - Clinical Trials - Immunology/Infectious Disease — Decatur, Georgia, United States
• Northwestern Memorial Hospital - ICU — Chicago, Illinois, United States
• Northwestern Medicine - Department of Obstetrics and Gynecology - Division of Female Pelvic Medicine and Reconstructive Surgery — Chicago, Illinois, United States
• University of Kentucky - UK Albert B Chandler Hospital — Lexington, Kentucky, United States
• University of Louisville School of Medicine - Surgery — Louisville, Kentucky, United States
• Henry Ford Health System - Henry Ford Hospital — Detroit, Michigan, United States
• William Beaumont Hospital - Royal Oak Campus - Infectious Disease — Royal Oak, Michigan, United States
• Washington University School of Medicine in St. Louis - Infectious Diseases — St Louis, Missouri, United States
• Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit — Durham, North Carolina, United States
• Duke University Hospital - Duke Medicine Pavilion - MICU — Durham, North Carolina, United States
• East Carolina University - Infectious Diseases and Tropical/Travel Medicine Clinic — Greenville, North Carolina, United States
• University of Cincinnati College of Medicine - Division of Infectious Diseases — Cincinnati, Ohio, United States
• Case Western Reserve University School of Medicine - Medicine - Infectious Diseases and HIV Medicine — Cleveland, Ohio, United States
• Oregon Health and Science University - Division of Pulmonary and Critical Care Medicine — Portland, Oregon, United States
• University of Pittsburgh - Medicine - Infectious Diseases — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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