CLINICAL TRIAL

Gentamicin Sulfate for Spinal Cord Injuries

Recruiting · 18+ · All Sexes · Ann Arbor, MI

This study is evaluating whether a drug treatment can reduce the occurrence of urinary tract infections and bladder complications in people with spinal cord injury.

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About the trial for Spinal Cord Injuries

Eligible Conditions
Wounds and Injuries · Neurogenic Bladder Dysfunction · Urinary Tract Infections · Spinal Cord Diseases · Spinal Cord Injuries · Communicable Diseases · Urinary Bladder, Neurogenic · Infections

Treatment Groups

This trial involves 2 different treatments. Gentamicin Sulfate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Gentamicin Sulfate
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gentamicin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
History of traumatic spinal cord injury (SCI) or non-traumatic spinal cord disease, (SCD) with sustained neurological dysfunction
At least 6 months post-initial hospital discharge following SCI/SCD onset
Neurogenic bladder
Ability to perform daily instillation on self or with help of others and willingness to adhere to the study regiment.
Provision of signed and dated informed consent form.
History of at least 2 documented urinary tract infection (UTI) during the previous 6 months (prior to screening)
Have a designated physician or health care provider for routine care
Use of clean intermittent catheterization or catheterization through a stoma (i.e. Mitrofanoff) as their primary method of bladder management
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Gentamicin Sulfate will improve 1 primary outcome and 2 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of 6 months.

Number of urinary tract infections (UTI)
6 MONTHS
Number of reported urinary tract infections (UTI) by participants
6 MONTHS
Change in score of Neurogenic Bladder Symptom Severity scale
6 MONTHS
Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms)
6 MONTHS
Change in score of Neurogenic Bowel Dysfunction
6 MONTHS
Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe)
6 MONTHS

Who is running the study

Principal Investigator
D. T.
Prof. Denise Tate, PhD
University of Michigan

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes spinal cord injuries?

Injury to the spinal cord is caused primarily by blunt trauma, motor vehicle collisions, and high-energy sports-related trauma. Minor injuries, especially penetrating trauma to the thoracic cavity and/or spinal cord, may be the cause of a substantial number of paraplegics. Intradural spinal cord injuries occur more frequently in penetrating thoracoabdominal trauma than in blunt thoracic injuries.

Anonymous Patient Answer

Can spinal cord injuries be cured?

It is argued that SCIs cannot be cured, as there is no'magic bullet'. However, we argue that advances in rehabilitation will substantially improve the quality of life for SCI patients and may allow them to live into their 30s or 40s. Thus, advances in spinal cord injuries research are necessary if we are to make significant progress in improving the lives of people with SCI.

Anonymous Patient Answer

What is spinal cord injuries?

The pathophysiology of SCI can be broadly categorized to peripheral injury, central injury, and global injury. After an injury, the injury and resulting injury causes the body to attempt to repair the injured tissues. While repair can occur, the injury is still considered an injured state. The injured state of the tissue is determined by the type of tissue being injured and the level of the injury. This article is intended to aid the study of pathophysiology of SCI in the context of global injuries, which are most common. It is hoped that the pathophysiology of SCI will ultimately lead to more effective SCI treatments.

Anonymous Patient Answer

How many people get spinal cord injuries a year in the United States?

Each year, an estimated 1.2 million injuries are reported and 2.2 million people receive treatment for these injuries. The most common age group for spinal cord injury is 30-44 years old. Patients ages 20-29 and 15-19 have the highest injury densities. Rates of admission for spinal cord injury vary widely between states and are lowest in the most rural counties. Those with lower levels of insurance are also more likely to be admitted to an inpatient hospital.

Anonymous Patient Answer

What are the signs of spinal cord injuries?

The main signs of spinal cord injury on admission are paralysis of the limbs on the same side as the actual injury and pain. Severe impairment may manifest itself as respiratory or autonomic failure. On admission, the most useful clinical signs related to the level and severity of the spinal cord injury are neurologic examinations. The presence of a tracheostomy tube is a useful predictor of mortality.

Anonymous Patient Answer

What are common treatments for spinal cord injuries?

This is a comprehensive survey of treatments used in the United States for SCI. The methods used and the relative rates of use for each treatment are similar to what has been reported in other places. The high proportions that are less utilized and that have not even been tested are worthy of concern. It appears that the research and treatment of SCI is fragmented. It is unclear how these results relate to improved outcomes. The high proportions that remain unfettered and are not even tested represent a potentially valuable opportunity for improvement.

Anonymous Patient Answer

Have there been any new discoveries for treating spinal cord injuries?

There have been many advances with the field of spinal cord injuries. The use of the [ventroperitoneal drain] has been very effective at preventing contamination between the ventricle and the abdominal cavity, which has reduced infection rates and significantly improved the quality of life for people whose spinal cord injuries were more severe than the average. However, spinal cord injuries are still devastating, life changing and have severe socioeconomic implications for those that are affected.\n\nThere has also been a discovery that has helped to ease pain from the spine that has become known as [pain medicine] (https://medusa.aero.me/vitamin-medications-for-pain-medication).

Anonymous Patient Answer

What is the primary cause of spinal cord injuries?

spina bifida and anencephaly, are the most important causes of paraplegias (paraplegia or tetraplegia) but spinal cord injuries could be classified by etiology, which is divided into three categories: trauma, ischemic, and neoplastic. TBI can also be classified by location: penetrating, indirect, or penetrating and direct. Penetrating TBI with CSF can occur throughout the body, such as [spinal vertebral fractures, penetrating thoracic or intercostal wounds, and penetrating intra-abdominal injuries] and spinal fractures [from a fall from a high tower, a motorcycle crash, or a car crash].

Anonymous Patient Answer

Have there been other clinical trials involving gentamicin sulfate?

Data from a recent study has a high risk of exclusion bias resulting in the loss of subjects with many variables including the duration of antibiotic treatment, duration of the preclinical stage, severity of injury, etc. Data from a recent study of this study suggest that more studies are warranted to better understand the mechanism of action of gentamicin sulfate.

Anonymous Patient Answer

Who should consider clinical trials for spinal cord injuries?

Clinical trials offer the latest, best evidence-based evidence, which is critical for informing treatment and care. Those with neurological injury, especially spinal cord injuries, should consider participating in clinical trials in order to receive the best care for their injury.

Anonymous Patient Answer

What are the latest developments in gentamicin sulfate for therapeutic use?

The gentamicin preparations available for the therapeutic use of intrathecal administration are a vast improvement over those available for topical ointment. The only caveat is that most of these preparations contain gentamicin (the drug) in the form of its salt, Gentamicin Sulfate, rather than the more desirable gentamicin in the free (or unbound) form. The clinical use of the other preparations in spinal injections or intrathecal injections will hopefully allow the clinician to use the more acceptable and desired forms of gentamicin for therapy. There is very strong evidence of the clinical benefits of antibiotics in treating spinal or central nervous system infections.

Anonymous Patient Answer

Is gentamicin sulfate typically used in combination with any other treatments?

Gentamicin sulfate is often used in combination with other treatments to treat most infections and to prevent some other infections. However, some of these treatments may also be efficacious when given by themselves. When used in combination with other antibiotics, gentamicin sulfate is typically combined with at least one other antibiotic, either other penicillins or cephalosporins, or with any of its analogs that have been shown to be effective in the treatment of staphylococcal infection. It may also be used in combination with antifungals, such as fluconazole, and antibacterials. Gentamicin sulfate is often combined with other medications, particularly antibiotics, through combinations like that given above.

Anonymous Patient Answer
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