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Trial record 1 of 1 for:    NCT03369951
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Minocycline Pharmacokinetics (ACUMIN)

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ClinicalTrials.gov Identifier: NCT03369951
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Condition or disease Intervention/treatment Phase
Bacterial Infection Drug: Minocycline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Open-Label Pharmacokinetic Study of Minocycline for Injection Following a Single Infusion in Critically-Ill Adults (ACUMIN)
Actual Study Start Date : February 7, 2018
Actual Primary Completion Date : July 20, 2019
Actual Study Completion Date : July 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minocin® IV
200 mg minocycline hydrochloride IV infusion over approximately 60 minutes, n=50
Drug: Minocycline
Minocycline is a semisynthetic derivative of tetracycline and is indicated for the treatment of infections due to susceptible isolates of designated microorganisms.




Primary Outcome Measures :
  1. Calculated exposure measures for area under the curve 0 to 24 hours after a dose (AUC0-24) [ Time Frame: 0 to 24 hours ]
  2. Calculated exposure measures for area under the curve from 0 to infinity (AUC0-inf) using free-drug concentrations [ Time Frame: 0 to 48 hours ]
  3. Calculated exposure measures for area under the curve from 0 to infinity (AUC0-inf) using total-drug concentrations [ Time Frame: 0 to 48 hours ]
  4. Calculated exposure measures for area under the curve to the last quantifiable sample (AUC0-last) [ Time Frame: 0 to 48 hours ]
  5. Calculated exposure measures for maximum plasma concentration (Cmax) [ Time Frame: 0 to 48 hours ]
  6. Calculated exposure measures for plasma concentration at 24 hours after dose (C24) [ Time Frame: 24 hours ]
  7. Individual post-hoc PK parameter estimates for area under the curve 0 to 24 hours after a dose (AUC0-24) [ Time Frame: 0 to 24 hours ]
  8. Individual post-hoc PK parameter estimates for area under the curve from 0 to infinity (AUC0-inf) using free-drug concentrations [ Time Frame: 0 to 48 hours ]
  9. Individual post-hoc PK parameter estimates for area under the curve from 0 to infinity (AUC0-inf) using total-drug concentrations [ Time Frame: 0 to 48 hours ]
  10. Individual post-hoc PK parameter estimates for area under the curve to the last quantifiable sample (AUC0-last) [ Time Frame: 0 to 48 hours ]
  11. Individual post-hoc PK parameter estimates for maximum plasma concentration (Cmax) [ Time Frame: 0 to 48 hours ]
  12. Individual post-hoc PK parameter estimates for plasma concentration at 24 hours after dose (C24) [ Time Frame: 24 hours ]
  13. Magnitude of the inter-individual variability for central volume of distribution (Vc) [ Time Frame: 0 to 48 hours ]
  14. Magnitude of the inter-individual variability for distribution clearance (CLd) [ Time Frame: 0 to 48 hours ]
  15. Magnitude of the inter-individual variability for free-drug clearance (CL) [ Time Frame: 0 to 48 hours ]
  16. Magnitude of the inter-individual variability for peripheral volume of distribution (Vp) [ Time Frame: 0 to 48 hours ]
  17. Magnitude of the inter-individual variability for total-drug clearance (CL) [ Time Frame: 0 to 48 hours ]
  18. Population mean PK parameter estimates for central volume of distribution (Vc) [ Time Frame: 0 to 48 hours ]
  19. Population mean PK parameter estimates for distribution clearance (CLd) [ Time Frame: 0 to 48 hours ]
  20. Population mean PK parameter estimates for free-drug clearance (CL) [ Time Frame: 0 to 48 hours ]
  21. Population mean PK parameter estimates for peripheral volume of distribution (Vp) [ Time Frame: 0 to 48 hours ]
  22. Population mean PK parameter estimates for total-drug clearance (CL) [ Time Frame: 0 to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369951


Locations
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United States, Georgia
Emory Decatur Hospital - Clinical Trials - Immunology/Infectious Disease
Decatur, Georgia, United States, 30033
United States, Illinois
Northwestern Memorial Hospital - ICU
Chicago, Illinois, United States, 60611-2908
Northwestern Medicine - Department of Obstetrics and Gynecology - Division of Female Pelvic Medicine and Reconstructive Surgery
Chicago, Illinois, United States, 60611
United States, Kentucky
University of Kentucky - UK Albert B Chandler Hospital
Lexington, Kentucky, United States, 40536
University of Louisville School of Medicine - Surgery
Louisville, Kentucky, United States, 40202-1622
United States, Michigan
Henry Ford Health System - Henry Ford Hospital
Detroit, Michigan, United States, 48202-2608
William Beaumont Hospital - Royal Oak Campus - Infectious Disease
Royal Oak, Michigan, United States, 48073-6700
United States, Missouri
Washington University School of Medicine in St. Louis - Infectious Diseases
Saint Louis, Missouri, United States, 63110-1010
United States, North Carolina
Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit
Durham, North Carolina, United States, 27701
Duke University Hospital - Duke Medicine Pavilion - MICU
Durham, North Carolina, United States, 27710
East Carolina University - Infectious Diseases and Tropical/Travel Medicine Clinic
Greenville, North Carolina, United States, 27834-9997
United States, Ohio
University of Cincinnati College of Medicine - Division of Infectious Diseases
Cincinnati, Ohio, United States, 45267
Case Western Reserve University School of Medicine - Medicine - Infectious Diseases and HIV Medicine
Cleveland, Ohio, United States, 44106-1716
United States, Oregon
Oregon Health and Science University - Division of Pulmonary and Critical Care Medicine
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh, Pennsylvania, United States, 15213-3403
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03369951    
Other Study ID Numbers: 16-0011
5UM1AI104681-07 ( U.S. NIH Grant/Contract )
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: December 4, 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
ACUMIN
Infusion
Injection
Minocycline
Pharmacokinetic
PK
Additional relevant MeSH terms:
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Bacterial Infections
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents