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Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria

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ClinicalTrials.gov Identifier: NCT01659515
Expanded Access Status : Available
First Posted : August 7, 2012
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Meiji Seika Pharma Co., Ltd.
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Brief Summary:
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.

Condition or disease Intervention/treatment
Infection Due to Resistant Organism Drug: Arbekacin Sulfate

Study Type : Expanded Access
Official Title: Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Arbekacin Sulfate
    Intravenous arbekacin in a total daily dose of 5-7 mg/kg
    Other Names:
    • Arbekacin
    • Habekacin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Subject is military health care beneficiary at least 18 years of age;
  2. 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;
  3. 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.
  4. Subject's infective organism is inhibited in vitro by arbekacin at a concentration ≤ 4 μg/mL;
  5. 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)];
  6. Subject has adequate venous access for intravenous administration of arbekacin.
  7. 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:

  1. Subject has a history of allergy or serious adverse reaction to aminoglycoside antibiotics;
  2. Subject is currently participating in another investigational new drug study.
  3. Subject has a positive serum pregnancy test or is breast feeding.

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): NCT01659515


Contacts
Contact: Michael Zapor, MD, PhD 301-319-9005 Michael.j.zapor.mil@mail.mil

Locations
United States, Maryland
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, United States, 20889
Contact: Michael Zapor, MD, PhD    301-677-8124    Michael.j.zapor.mil@mail.mil   
Principal Investigator: Michael Zapor, MD, PhD         
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Meiji Seika Pharma Co., Ltd.
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Michael Zapor, MD, PhD Walter Reed Army Institute of Research (WRAIR)

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01659515     History of Changes
Other Study ID Numbers: S-11-0001
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Infection
Communicable Diseases
Arbekacin
Dibekacin
Anti-Infective Agents
Anti-Bacterial Agents