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Title: IDSA: Linezolid Equivalent To Vancomycin In Treating Neonates, Children \
URL: http://www.pslgroup.com/dg/221736.htm
Doctor's Guide
October 28, 2002


By Ed Susman
Special to DG News

CHICAGO, IL -- October 28, 2002 -- The antibiotic linezolid appears to be at least as effective as the gold standard treatment vancomycin treatment of various infections in children, according to a series of poster presentations.

Reporting findings, doctors at the 40th annual meeting of the Infectious Diseases Society of America, said:

---Linezolid was better tolerated and as effective as vancomycin in the treatment of known or suspected resistant gram-positive infections in children from birth to 12 years of age.
---Linezolid proved as effective as vancomycin among neonates, including those children infected methicillin-resistant Staphylococcus aureus or methicillin resistant enterococci.
---Linezolid was at least as effective as vancomycin among children with nosocomial pneumonia caused by resistant bacteria -- and tended to alleviate symptoms faster than vancomycin.

"It is important that we do these studies on children," said Sheldon Kaplan, MD, professor of pediatrics at the Baylor College of Medicine, Houston, Texas. "We feel very strongly that if you don't study a drug in pediatric settings you are not doing what is right for children. Children are not just little adults."

He said the studies have shown that children metabolize linezolid more quickly than adults so they require a greater dose of the drug per kilogram than adults.

In his report, children whose parents completed a five-page informed consent document were randomized to receive either linezolid or vancomycin if the children had known or suspected nosocomial pneumonia, complicated skin or skin structure infections, bacteremia or other infections. Dr. Kaplan and colleagues from 59 institutions in the United States and Latin America randomized 215 patients to linezolid and 105 to vancomycin.

Overall, the results were similar: in the intention to treat analysis 79.1 percent of linezolid patients versus 74.1 percent of vancomycin patients achieved a cure. Of those patients clinically evaluable, 89.3 percent of linezolid patients were clear of infection compared with 84.5 percent of the vancomycin patients; of the patients who underwent microbiological evaluation, 88.2 percent of linezolid patients and 87 percent of vancomycin patients were disease-free. Dr. Kaplan said those differences did not reach statistical significance.

Drug-related discontinuations reached 6 percent among the vancomycin patients and was less than 1 percent among the linezolid patients, a difference that was significant, he said.

In another study, Jaime Deville, MD, assistant clinical professor of pediatrics at the University of California and Los Angeles, said that among neonates, linezolid proved successful at clearing infections most related to line emplacement.

He concurred that children are different in their reaction to drugs. With linezolid, he said, neonates are a lot like adults in metabolism of linezolid until their kidneys are developed, then they act like children. In some case dosing three times a day is necessary to maintain therapeutic levels of the medication.

Dr. Deville enrolled 63 babies into his study -- 43 of whom were put on linezolid. In the intention to treat analysis, 77.5 percent of the linezolid babies were cures of their infections, compared with 61.1 percent of the vancomycin-treated children.

Ma. Royo Morfin, MD, a pediatrician at Hospital Civil de Guadalajara in Mexico, enrolled 49 patients with nosocomial pneumonia to receive either linezolid or vancomycin. After three days on treatment one-third of the linezolid patients still had symptoms compared to 80 percent of vancomycin patients; after 10 days, 20 percent of linezolid patients still had symptoms compared with 33.3 percent of the vancomycin patients.

Overall, Dr. Kaplan said, "Linezolid is an effective and well-tolerated empiric antibiotic therapy for known or suspected resistant gram-positive infections in children.

The studies were sponsored by Pharmacia Corp., Kalamazoo, Michegan.

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