- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01659515
Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria
December 30, 2019 updated by: U.S. Army Medical Research and Development Command
Arbekacin for the use of infection caused by multidrug-resistant organisms
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this protocol is to make arbekacin available for treatment of patients with infections caused by multidrug-resistant organisms when treatment with other antibiotics cannot be used due to unavailability, intolerance, contraindications, or treatment non-response.
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical Center (WRNMMC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 isolate is a multidrug-resistant (MDR) bacterium defined as any of the following:
- Gram-negative bacterium that is non-susceptible to all index antibiotics within 3 or more of 6 antibiotic classes including aminoglycosides (amikacin, gentamicin, tobramycin), beta-lactam/beta-lactam inhibitor combinations (piperacillin-tazobactam, amoxicillin-clavulanate), carbapenems (imipenem, ertapenem), fluoroquinolones (ciprofloxacin, levofloxacin), cephalosporins (ceftazidime, cefepime, ceftriaxone), and sulbactam (ampicillin-sulbactam);
- Extended Spectrum β-lactamase (ESBL) producing Gram-negative bacterium;
- Carbapenemase resistant Enterobacteriaceae;
- Cephalosporin resistant Klebsiella species;
- Methicillin-resistant Staphylococcus aureus (MRSA);
- Vancomycin resistant Enterococcus species;
- Staphylococcus aureus that is non-susceptible to vancomycin.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Zapor, MD, PhD, Walter Reed Army Institute of Research (WRAIR)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 3, 2012
First Submitted That Met QC Criteria
August 3, 2012
First Posted (ESTIMATE)
August 7, 2012
Study Record Updates
Last Update Posted (ACTUAL)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 30, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-11-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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