Infection Due to Resistant OrganismNCT01659515
Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria
A study testing Arbekacin Sulfate in people with Infection Due to Resistant Organism, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
Arbekacin for the use of infection caused by multidrug-resistant organisms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Due to Resistant Organism
- What is being tested?
- Arbekacin Sulfate
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, 20889
About this study
Arbekacin for the use of infection caused by multidrug-resistant organisms
Read the 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.
- Conditions
- Infection Due to Resistant Organism
- Being tested
- Arbekacin Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arbekacin SulfateDrug
Also called Arbekacin, Habekacin
Intravenous arbekacin in a total daily dose of 5-7 mg/kg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Due to Resistant OrganismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Meiji Seika Pharma Co., Ltd., Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Michael Zapor, MD, PhD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659515
- Sponsor's protocol ID
- S-11-0001
- Status last verified
- Dec 2019
- First submitted
- 3 Aug 2012
- Last updated
- 2 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arbekacin Treatment of Adult Patients With Infections Caused by Multidrug-resistant Bacteria
- ClinicalTrials.gov ID
- NCT01659515
- Acronym / sponsor ID
- S-11-0001
- Conditions
- Infection Due to Resistant Organism
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Meiji Seika Pharma Co., Ltd., Uniformed Services University of the Health Sciences
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Subject's infective organism is inhibited in vitro by arbekacin at a concentration ≤ 4 μg/mL;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arbekacin SulfateAlso: Arbekacin, HabekacinIntravenous arbekacin in a total daily dose of 5-7 mg/kg | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zapor, MD, PhD principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arbekacin Sulfate in people with Infection Due to Resistant Organism, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.