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

Expanded access is currently available for this treatment.
Verified March 2014 by U.S. Army Medical Research and Materiel Command
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
ClinicalTrials.gov Identifier:
NCT01659515
First received: August 3, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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 Intervention
Infection Due to Resistant Organism
Drug: Arbekacin Sulfate

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

Further study details as provided by U.S. Army Medical Research and Materiel Command:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659515

Contacts
Contact: Michael Zapor, MD, PhD 301-677-8124 Michael.j.zapor.mil@mail.mil
Contact: Christa M Madock (301) 619-4649 christa.madock@us.army.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
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01659515     History of Changes
Other Study ID Numbers: S-11-0001
Study First Received: August 3, 2012
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Infection
Habekacin
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014