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

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center (WRNMMC)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
U.S. Army Medical Research and Development Command

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uniformed Services University of the Health Sciences
Meiji Seika Pharma Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings