Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria (NCT01659515) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria
United States
Plain-language summary
Arbekacin for the use of infection caused by multidrug-resistant organisms
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is military health care beneficiary at least 18 years of age;
✓. Subject is a Walter Reed National Military Medical Center patient deemed by the primary medical or surgical team as having a bacterial infection of the respiratory tract, bloodstream, skin, soft tissue, bone, or genitourinary tract;
✓. Subject is allergic to or intolerant of antibiotics to which the infective organism is susceptible; Or The use of antibiotics to which the subject's infective organism is susceptible is contraindicated; Or
✓. Subject's infective organism is inhibited in vitro by arbekacin at a concentration ≤ 4 μg/mL;
✓. Subject is able to give written or witnessed verbal informed consent \[An exception from the general requirements for informed consent can be made based upon the criteria specified in 21 Code of Federal Regulations 50.23 (a and c)\];
✓. Subject has adequate venous access for intravenous administration of arbekacin.
✓. Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner, or sterile sexual partner) for at least 30 days prior to receipt of arbekacin and must agree to continue using such precaution for at least 30 days after last dose of arbekacin; the subject must also have a negative pregnancy test within 24 hours prior to initial dose of arbekacin.
Exclusion criteria
✕. Subject has a history of allergy or serious adverse reaction to aminoglycoside antibiotics;
✕. Subject is currently participating in another investigational new drug study.
✕. Subject has a positive serum pregnancy test or is breast feeding.
Trial details
NCT IDNCT01659515
SponsorU.S. Army Medical Research and Development Command