Abstract
Pediatric and adult community-acquired respiratory tract infections remain some of the most common reasons for visits to primary care practitioners, and the antibiotics used to treat them are historically highly profitable for their manufacturers. Despite these facts and the continued evolving need for new treatments for these infections, virtually no new agents have been developed in the past decade. This review explores some regulatory guidelines that could potentially explain the dearth of development, and it provides some practical answers for resolving them.
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Whitney CG, Farley MM, Hadler J, et al.: Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med 2003, 348:1737–1746.
Dagan R, Givon-Lavi N, Zamir O, et al.: Effect of a nonavalent conjugate vaccine on carriage of antibiotic-resistant Streptococcus pneumoniae in day-care centers. Pediatr Infect Dis J 2003, 22:532–539.
Givon-Lavi N, Fraser D, Dagan R: Vaccination of daycare center attendees reduces carriage of Streptococcus pneumoniae among their younger siblings. Pediatr Infect Dis J 2003, 22:524–531.
Kyaw MH, Lynfield R, Schaffner W, et al.: Effect of introduction of the pneumococcal conjugate vaccine on drug-resistant Streptococcus pneumoniae. N Engl J Med 2006, 354:1455–1463.
Millar EV, O’Brien KL, Watt JP, et al.: Effect of community-wide conjugate pneumococcal vaccine use in infancy on nasopharyngeal carriage through 3 years of age: a cross-sectional study in a high-risk population. Clin Infect Dis 2006, 43:8–15.
Huijsdens XW, van Santen-Verheuvel MG, Spalburg E, et al.: Multiple cases of familial transmission of community-acquired methicillin-resistant Staphylococcus aureus. J Clin Microbiol 2006, 44:2994–2996.
Marcinak JF, Frank AL: Treatment of community-acquired methicillin-resistant Staphylococcus aureus in children. Curr Opin Infect Dis 2003, 16:265–269.
Fuller JD, Low DE: A review of Streptococcus pneumoniae infection treatment failures associated with fluoroquinolone resistance. Clin Infect Dis 2005, 41:118–121.
Clinical trial design for studies of otitis media. Presented at the U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Anti-infective Drugs Advisory Committee, Gaithersburg, MD; July, 11, 2002.
Clinical trial design in acute bacterial sinusitis (ABS). Presented at U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Anti-infective Drugs Advisory Committee, Gaithersburg, MD; October 29, 2003.
Gilbert K, Fine MJ: Assessing prognosis and predicting patient outcomes in community-acquired pneumonia. Sem Resp Infect 1994, 9:140–152.
Martinez JA, Horcajada JP, Almela M, et al.: Addition of a macrolide to a beta-lactam-based empirical antibiotic regimen is associated with lower in-hospital mortality for patients with bacteremic pneumococcal pneumonia. Clin Infect Dis 2003, 36:389–395.
Song JH, Jung SI, Ki HK, et al.: Clinical outcomes of pneumococcal pneumonia caused by antibiotic-resistant strains in Asian countries: a study by the Asian Network for Surveillance of Resistant Pathogens. Clin Infect Dis 2004, 38:1570–1578.
Pallares R, LiZares J, Vadillo M, et al.: Resistance to penicillin and cephalosporin and mortality from severe pneumococcal pneumonia in Barcelona, Spain. N Engl J Med 1995, 333:474–480.
Viladrich PF, Cabellos C, Pallares R, et al.: High doses of cefotaxime in treatment of adult meningitis due to Streptococcus pneumoniae with decreased susceptibilities to broad-spectrum cephalosporins. Antimicrob Agents Chemother 1996, 40:218–220.
Schaad UB: Predictive value of double tympano centesis in acute otitis media. Pharmacotherapy 2005, 25:105S–108S.
Powers JH: Microbiologic surrogate end points in clinical trials of infectious diseases: example of acute otitis media trials. Pharmacotherapy 2005, 25:109S–123S.
Toltzis P: Comparison of amoxicillin with alternative agents for the treatment of acute otitis media in children. Pharmacotherapy 2005, 25:124S–129S.
American Academy of Pediatrics Subcommittee on Management of Acute Otitis Media: Diagnosis and management of acute otitis media. Pediatrics 2004, 113:1451-65.
Amsden GW: Interrelationship of pharmacokinetics/pharmacodynamics: antibiotic dosing for the future. In Antibiotics and the Lung. Edited by Cazzola M, Blasi F, Ewig S. Leeds Maney Publishing; 2004:1–12.
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Amsden, G.W. Regulatory disincentives for developing antibiotics for common indications?. Curr Infect Dis Rep 9, 29–34 (2007). https://doi.org/10.1007/s11908-007-0019-y
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DOI: https://doi.org/10.1007/s11908-007-0019-y