Months ago, David McGee was looking forward to his 19-day dream cruise to Panama, which was scheduled before the COVID-19 pandemic. But when he was diagnosed with a vertebral infection, he elected to participate in the Mino-Lok trial to clear his line infection and thereby preserve his central line. In this trial, systemic antibiotics were administered to treat his back infection, which included discitis, or an infection in his spine.
Editor's note: The photo of David (second from right) on his cruise was taken before the coronavirus pandemic and may not reflect current health and safety policies.
This study, conducted at Atrium Health, explores treating infections without removing an indwelling catheter line. By skipping this step, David’s treatment and recovery could be quicker, more comfortable, and less risky.
This collaborative effort between physicians and researchers led to new ways to improve care and benefit patients.
The Unexpected Happens — Right Before a Dream Cruise
In the months leading up to David’s highly anticipated cruise with his family, he started to experience extreme back pain. After going for a checkup, a spinal disc infection in his vertebrae, also known as discitis, was found. Left untreated, a person with discitis experiences severe back pain, often affecting quality of life.
To treat the discitis, David had to make account for his indwelling line. Also known as a central venous catheter, this tube is placed in a large vein to administer medication, fluids, or perform medical tests quickly. Typically, any treatment of an infection would involve the removal and replacement of a central line, which takes more time and can be uncomfortable.
“At first, I thought this was typical back pain that comes with age,” said David, “but as the days passed and I couldn’t get out of bed due to the agonizing pain, I knew something was wrong and I was determined to get the help I needed before my cruise.”
Unfortunately, after his examination for back pain, the bacteria in his vertebrae was found to have reached the central line. The official diagnosis became an infected central line, which meant that David had a serious infection in the bloodstream resulting from bacteria entering the body through the central line. With his current condition, David qualified to participate in an ongoing clinical trial for a noninvasive, streamlined treatment called Mino-Lok.
Nirav Shah, PhD, is the lead coordinator for this trial and is responsible for enrolling 6 out of the 7 patients in this study. As a research coordinator, he has played a large role in David’s diagnosis and treatment by facilitating high-quality clinical research.
In the Mino-Lok trials, Shah has managed everything from the data binder and timeline to medications, dosing, and gathering signatures. Under this leadership and the care of two other doctors, David McGee was to receive excellent care.
Undergoing Innovative Treatment
David came under the collaborative care of Alfred Papali, MD a pulmonary disease specialist at Carolinas HealthCare System Pulmonary Care — Pineville, and Toan Huynh, MD, principal investigator of the study and a surgical critical care specialist at Atrium Health’s Carolinas Medical Center.
Mino-Lok sends antibiotics through the catheter to treat the infection while preserving the central line. While the risk of removing an indwelling line only involves some discomfort and pain, inserting a new catheter can involve bleeding and injury to the vessel. These risks can be avoided if the central line is preserved.
David was admitted to Atrium Health Pineville and randomized to receive either standard of care or the innovative treatment in a controlled setting. During his stay, his care team sent antibiotics into a catheter to treat the discitis infection as well as the infection in the central line.
In order to increase David’s chances of recovery in time for his cruise, the Trauma and Acute Care Surgery Research team, led by Research Manager Julia Raddatz, went straight to work. After David decided to participate in the study, Research Coordinator Nirav Shah worked at his bedside with his clinical teams to orchestrate the tests and procedures that led to David receiving his first study treatment on the same day his diagnosis was made.
Urgent action and careful attention to detail is crucial to ensuring that a patient’s participation in a clinical trial never delays or interrupts their care. David was in the hospital for a week and received a new lock therapy of the antibacterial solution once a day.
“My experience with my care team was spectacular. They made me feel at ease the entire time and I had no complications or issues during my stay,” said David.
By the end of his week-long stay, David felt great and was ready to go home and finish the treatment with a few rounds of oral antibiotics. He was able to keep the same central line and was healthy enough to go on his cruise.
The Study Continues
”I hope the Mino-Lok study continues to be available for patients like me,” reflects David. “I’m forever grateful that Atrium Health was participating in the study and am glad to be a part of it. It’s truly made a difference in my quality of life.”
While David may have benefited greatly from this study, we still have a lot to learn. With each successful treatment of qualified patients, chances increase for Mino-Lok to be proved efficacious for patients like David.
“Becoming mainstream is the goal of every clinical trial— also to improve care and show its success,” says Dr. Papali. “If and when it does become mainstream, it can provide another therapeutic option to someone who has very few options to preserve the central line.”
Four patients in the Charlotte region have qualified to enroll in the trial and the study has around 80 patients nationwide.
“This study affords us the ability to collaborate with Dr. Papali from Atrium Health Pineville and with other facilities within Atrium Health. Collaborating is an exciting part of this trial,” says Dr. Huynh regarding the entire experience.
Likewise, Dr. Papali is thrilled to collaborate with colleagues in other specialties and says that clinical trials like these “open networking opportunities and allow doctors to do great work together and benefit patients.”
After David’s recovery, he was more than well enough to go on vacation with his aunt, uncle, and siblings. He didn’t have to miss his 19-day Panama Canal cruise and had a trip that he will forever remember and cherish.
To learn more about Atrium Health’s Clinical Trials, click here.
