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Aspergillus, Serratia and other catalasepositive microorganisms · Chronic granulomatous disease (CGD)(48,49) Mycobacteria · Non-tuberculosis: associated with defects of IFNg/IL12 pathway · Immunocompromised hosts – patients under immunomodulation/suppression (e.g. anti-TNF drugs) (165) · Usually older children – develops 2 years from primary infection Neisseria gonorrhoeae · Adolescents and newborns Neisseria menigitidis · Adolescents Pseudomonas aeruginosa · Usually inoculation injuries (i.e. through sport shoe soles) – therefore >1 year old Salmonella spp · Common agent in tropics and in SCD (166) · (147) Brucella · Sacroiliitis – endemic areas around the Mediterranean, occupational disease in people working with farm animals Bartonella henselae · Kitten exposure Coxiella · Associated with chronic OM · Domestic animals – very rare C. albicans · Neonate, damaged bone, nosocomial, immunodeficiencies Notes – PVL = panton-valentine leucocidin; SCD = sickle cell disease; TB = tuberculosis – $ = and most of Scandinavian countries 8.2 Antibiotic recommendations in BJI – summary It is important to know the different concentration, formulation, and availability for each antibiotic for each country. The use of a narrow-spectrum antibiotic is recommended and empiric antibiotic treatment must target common pathogens (S. aureus, K. kingae and group A beta-haemolytic streptococcus) considering their local prevalence and antibiotic resistance. process, help fellow patients, and contribute to the advancement of medical knowledge. Healthcare costs are also a consideration for clinical trial entry, as expenses associated with study treatment are typically covered. Patients are also likely to volunteer as a study subject when the goal of treatment is focused on improving quality of life. “If a treatment is novel and offers benefits with low risk,” observes Dr. Hotchkiss, “enrollment is more attractive to a patient.” In addition, a bit of publicity can play an important role in generating interest in study enrollment. Dr. Hotchkiss points to the influence of Internet sources such as the NIH-sponsored ClinicalTrials.gov, as well as targeted announcements in other communication vehicles which help to spread the word about trials and recruitment. In fact, news about the current trial in the treatment of Dupuytren’s contracture, a degenerative disease of the hand, circulated so quickly that HSS reported immediate and overwhelming interest in participation. Beverly Lambert’s Story For Beverly Lambert, singing and playing the piano would always go hand in hand, until a crippling disease took away mobility in her fingers. “As a vocal coach, I use the piano to practice scales with my students,” explains Ms. Lambert, age 58, of Fairfield, Connecticut. “The problem in my right hand not only impacted my ability to teach, it had a great effect on my livelihood.” Dupuytren’s contracture is a progressive shrinkage of the connective tissue in the palm of the hand that can make fingers curl in. The cause is unknown although minor injury and genetics (in Ms. Lambert’s case, both her mother and father have the condition) may contribute to disease. Surgical treatment can restore normal movement to the fingers, but is often associated with lengthy recovery, potential nerve damage, and high rate of recurrence. “During a visit for a second opinion about surgery for my condition, I was informed about a clinical trial to test a nonsurgical treatment and I wanted to learn more,” recalls Ms. Lambert. “After searching and waiting, I found Special Surgery and Dr. Hotchkiss.” At HSS, Ms. Lambert signed up for a randomized, controlled clinical trial to explore the safety and efficacy of enzyme (collagenase) injections for Dupuytren’s contracture, which included 20 participants. A Phase III study, recent findings published in the New England Journal of Medicine revealed that the collagenase injection showed promise in restoring nearly full extension of the affected fingers. “The idea behind the collagenase is dissolving the diseased tissue, rather than surgically removing it,” explains Dr. Hotchkiss. Based on those findings, an FDA Advisory Committee has recommended approval of the injection, which would make it the first FDAapproved treatment alternative to surgery for this condition. For three months, Ms. Lambert received the placebo injection in her fingers, and following her enrollment opted to receive the medication. Her results were immediate. “It was very frustrating to receive the placebo during the trial, but I knew that it was a possibility and that I could eventually get the medication,” says Ms. Lambert. “For me, participation was worth any reservations, pain and time involved to get back to my life.” Clinician Considerations Treating physicians who are also investigators recognize their primary duty is to promote their patients’ welfare. 3 Research Breakthroughs Clinical Trials at HSS B ecoming involved in a clinical trial gives patients the opportunity to have a seat at the table of innovation,” says Robert Hotchkiss, MD, Medical Director of Clinical Research, HSS. “Study participation is about taking a more active role in health care.” Why Participate in a Clinical Study? From a medical research perspective, the benefits include a better understanding of disease, enhanced treatment measures, and improved quality of care. For patients, the decision to
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