Clinical trial NCT01659515: Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria
Official title: Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Infection Due to Resistant Organism
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: Meiji Seika Pharma Co., Ltd.
name: Uniformed Services University of the Health Sciences
First posted: 2012-08-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Arbekacin for the use of infection caused by multidrug-resistant organisms

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center (WRNMMC)
state: Maryland
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: Michael Zapor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: