Sixteen-year-old Sebastian DeLeon, who had recently worked as a camp counselor in Broward County, was vacationing with his family in Orlando when he experienced a pounding headache

By Devan Stuart Lesley
Updated August 24, 2016 12:30 PM

From the moment he walked into Orlando’s Florida Hospital for Children with a headache so severe that he couldn’t tolerate the slightest touch, the odds of survival were stacked against 16-year-old Sebastian DeLeon. But thanks to a sharp-eyed laboratory coordinator and the quick delivery of a drug not yet approved for treatment of his condition, the South Florida teen is on the mend and his case may prove a precedent for emergency room protocols nationwide.

DeLeon, who had recently worked as a camp counselor in Broward County, was vacationing with his family in Orlando when he experienced a pounding headache on Friday, August 7 and went to the emergency room. His symptoms, including signs of meningitis, worsened the next day and on Sunday, he was admitted to the hospital. Doctors initially suspected meningitis, an infection of the fluid and membranes around the brain and spinal cord that can cause brain damage in a matter of hours and prove fatal within 24 hours. But a test of his spinal fluid turned up something different – primary amoebic meningoencephalitis (PAM), caused by the brain-eating naegleria fowleri amoeba and fatal in 97 percent of cases.

At first, Laboratory Coordinator Sheila Black didn’t notice the amoeba’s presence. When lying still, these single-cell organisms resemble white blood cells under a microscope. But after reading DeLeon’s medical chart, noting his age and the fact that he had recently swam in a warm, freshwater lake – a key environment for the amoeba – she took a second look.

“I went back and studied it for a while,” Black told reporters during a Tuesday media conference, reports CBS Miami. “The amoeba aren’t always necessarily very active, so you literally have to look and watch. And that’s when I saw the pseudopods moving on the amoeba.”

That second look set off a flurry of phone calls between the hospital pharmacist, the U.S. Centers for Disease Control & Prevention (CDC), the Florida Health Department and Todd MacLaughlin, CEO of Profounda, Inc. The Orlando pharmaceutical firm distributes a hard-to-get drug called miltefosine, launched under the trade name Impavido in March. Originally developed in the 1980s as an experimental cancer treatment, it was approved by the US Food and Drug Administration (FDA) for treatment of leishmaniasis parasites, spread by the bite of certain types of sandflies, in 2014. But since 2013, CDC officials have recommended miltefosine as a treatment for PAM and a related condition called granulomatous amoebic encephalitis.

RELATED VIDEO: What You Need to Know: Naegleria Fowleri, The Brain-Eating Bacteria

MacLaughlin’s first call came Sunday afternoon while he was in Boston for a medical conference. On the line was the hospital pharmacist, who confirmed a patient with the amoeba. MacLaughlin immediately called his son Michael, who works as Profounda’s operations manager and is the only other person with the passcode to open a safe that guards the drug. Just five minutes home from a trip to Tampa to see rock band Blink-182 perform, Michael, set out immediately.

“I knew that minutes counted,” he tells PEOPLE, noting that the Profounda office is a six-minute drive from his home and 12 minutes from the hospital. “I may or may not have sped a little. The pharmacist said it felt like a drug deal because I pulled up in my car still in my pajamas, hadn’t shaved, and just handed off the package. She said, ‘Do we need any paperwork?’ I said ‘I’ll bring that later.’

“It was a mix of fear and excitement,” he continued. “Fear because the death rate is 97 percent. Excitement because they were close and I knew I could get it to them quickly.”

Less than an hour after the first phone call to Todd MacLaughlin, DeLeon became the first patient in history to take the drug orally for treatment of PAM. In order to slow the amoeba’s activity and stall potential brain damage, doctors typically place patients in a chemically-induced coma and drop their body temperature, literally stopping the warmth-loving amoeba in its tracks. Because few hospitals keep miltefosine on hand, the drug generally must be shipped on demand, which can take hours or even days, depending on the location. So, by the time the drug arrives, doctors are forced to grind the tablets into powder form, mix it with water and administer it intravenously.

Miltefosine is effective for treating PAM in large part because it’s able to cross the blood-brain barrier, which means it enters the brain and kills the amoeba, despite the body’s natural defenses that work to keep foreign agents out. But because more than 30 hours had passed since DeLeon first experienced symptoms, his condition was tenuous.

“When the family came to me, I had to tell them to say their goodbyes,” said Dr. Humberto Liriano, who treated DeLeon and choked back tears as he described the case at Tuesday’s media conference. “I had to tell them, ‘Tell him everything you would want to tell your child because I don’t know if he will wake up.’ ”

“This infection can be rapidly fatal,” added Dr. Federico Laham, a hospital pediatrician specializing in infectious diseases. “Minutes count and having the drug rapidly at hand … is crucial.”

After taking the drug, DeLeon was placed in coma and his temperature dropped to just 33 degrees. Doctors monitored his condition over the next three days before waking him. Against tremendous odds, DeLeon emerged only the fourth person in the U.S. in 50 years to survive the naegleria fowleri amoeba. A patient survived the condition in 1962. And a California patient beat the odds in 1978. Miltefosine proved effective for 12-year-old Kali Hardig of Arkansas, infected while swimming at a water park in 2013. That same summer, an 8-year-old Texas boy also survived, though he suffered brain damage and lost vision in one eye because of the days-long delay in treatment after his symptoms began.

“It is so rare that a lot of times we don’t think of it and that’s where a delay occurs in starting a treatment,” Dr. Dennis Hernandez, head of the hospital’s emergency department, told reporters. “It wasn’t very clear-cut and I’m still shaking about the whole case.”

Because PAM symptoms mimic those of bacterial and viral meningitis, patients often are sent home, only to return too late for treatment to be effective, Todd MacLaughlin tells PEOPLE.

“That story is repeated time and time again,” he said.

MacLaughlin is pinning his hopes on awareness of the outcome in DeLeon’s case to bring about change on the federal level and in hospital protocols nationwide. The naegleria fowleri amoeba, which enters the brain via water forced through the nasal cavity, is the world’s second-leading cause of parasitic death, killing upward of 30,000 a year. But it is far less prevalent here in the U.S., where only about 30 cases per year are reported and 80 percent of those occur in Florida and Texas.

MacLaughlin suspects misdiagnosis makes the true number of cases significantly higher. So, based on CDC data that illustrates effectiveness and its success in DeLeon’s case, he says he’ll lobby the FDA for an “orphan indication” approval of miltefosine as a treatment for the condition. Such approvals are reserved for cases in which rapid mortality makes clinical trials of drugs for certain conditions impossible.

He’s also working in tandem with the Kyle Cares Foundation and the Jordan Smelski Foundation for Amoeba Awareness, established in honor of children lost to the naegleria fowleri amoeba, to bring about change in hospitals nationwide. Together, they’re encouraging hospitals to improve emergency room protocols, making it standard practice to ask patients presenting with the common symptoms whether they’ve been in fresh water in the recent past – a move that the Florida Hospital for Children made only months ago, after a training session with the Jordan Smelski Foundation – and to have doses of miltefosine on hand at all times.

“If you manufacture a drug, you have to make a minimal quantity of it anyway,” he tells PEOPLE. “But even if you combine the approved indications and non-approved amoeba indication, it’s still less than 50 cases each year. So, what happens is you order a product, put it in your warehouse, watch it expire and hope you get it shipped out in time when someone does need it. That model doesn’t work. My model says, ‘What if we’re able to get the inventory into as many hospitals as possible knowing that 90 percent of them won’t ever use it, but if it is ever needed, it’s beneficial?’ What has happened in Orlando shows that if you can get the drug on time, you can save a life. We know that the drug works and we know that time matters.”

Meanwhile, DeLeon is talking, moving around with the help of a walker and expected to make a full recovery with therapy.

“We are so thankful that God has given us this miracle through this medical team … to have our son back and having him full of life,” his mother, Brunilda Gonzalez, said during the media conference before hurrying back to her son’s room. “He’s a very energetic, adventurous, wonderful teen. We are so thankful for the gift of life.”