Status:
COMPLETED
Minocycline Pharmacokinetics (ACUMIN)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
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 eva...
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 eva...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03369951
Start Date
March 28 2018
End Date
July 20 2019
Last Update
December 3 2020
Active Locations (15)
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1
Emory Decatur Hospital - Clinical Trials - Immunology/Infectious Disease
Decatur, Georgia, United States, 30033
2
Northwestern Memorial Hospital - ICU
Chicago, Illinois, United States, 60611-2908
3
Northwestern Medicine - Department of Obstetrics and Gynecology - Division of Female Pelvic Medicine and Reconstructive Surgery
Chicago, Illinois, United States, 60611
4
University of Kentucky - UK Albert B Chandler Hospital
Lexington, Kentucky, United States, 40536