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A Study of 5-Day Cefdinir Treatment for Streptococcal Pharyngitis in Children FREE

Kenneth J. Tack, MD; James A. Hedrick, MD; Edward Rothstein, MD; Mary Anne Nemeth; Constance Keyserling, MS; Michael E. Pichichero, MD
Arch Pediatr Adolesc Med. 1997;151(1):45-49. doi:10.1001/archpedi.1997.02170380049008.
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Objective:  To compare the safety and efficacy of a 5-day regimen of cefdinir with those of a conventional 10-day regimen of penicillin V for the treatment of streptococcal pharyngitis in children.

Design:  Investigator-blind, randomized controlled trial.

Setting:  Primary care, ambulatory.

Patients:  Children aged 1 to 12 years with signs and symptoms of pharyngitis and a positive result on a rapid screening test for Streptococcus pyogenes (ie, a convenience sample). Four hundred eighty-two patients were enrolled in the study, and 440 were clinically and microbiologically evaluable. The most common reasons patients were nonevaluable were failure to return for specified visits and noncompliance with the administration of the medication; 2 patients receiving penicillin V discontinued use of the drug because of adverse events.

Intervention:  Patients were randomized to receive either 7-mg/kg cefdinir, twice daily, for 5 days or 10-mg/kg penicillin V potassium, 4 times daily, for 10 days.

Main Outcome Measures:  The eradication of S pyogenes and the clinical cure of the signs and symptoms of pharyngitis, both determined 5 to 10 days after the completion of therapy.

Results:  Streptococcus pyogenes was eradicated in 201 (90%) of the 224 patients receiving cefdinir and 155 (72%) of the 216 patients receiving penicillin V (95% confidence interval [CI], 10.7%-25.1%; P<.001). The clinical cure rates were 92% and 91% in the groups receiving cefdinir and penicillin V, respectively (95% CI, −4.5% to 6.1%; P=.80). Adverse events, regardless of the opinion of the investigator about their relationship to the study medication, occurred in 12.5% of the patients receiving cefdinir and 13.6% of the patients receiving penicillin V (P=.69).

Conclusions:  A 5-day regimen of cefdinir eradicated a higher proportion of S pyogenes than a 10-day regimen of penicillin V. No difference was noted between the regimens for clinical outcomes or adverse event rates.Arch Pediatr Adolesc Med. 1997;151:45-49

REFERENCES

Neu HC, Saha G, Chin NX.  Comparative in vitro activity and β-lactamase stability of FK482, a new oral cephalosporin . Antimicrob Agents Chemother . 1989;; 33:1795-1800.
Wise R, Andrews JM, Thornber D.  The in vitro activity of cefdinir (FK 482), a new oral cephalosporin . J Antimicrob Chemother . 1991;;28:239-248.
Brook I.  Role of beta-lactamase–producing bacteria in the failure of penicillin to eradicate group A streptococci . Pediatr Infect Dis J . 1985;;4:491-495.
Dajani A, Taubert K, Ferrieri P, Peter G, Shulman S.  Treatment of acute streptococcal pharyngitis and prevention of rheumatic fever: a statement for health professionals . Pediatrics . 1995;;96:758-764.
Portier H, Chavanet P, Waldner-Combernoux A, et al.  Five versus ten days treatment of streptococcal pharyngotonsillitis: a randomized controlled trial comparing cefpodoxime proxetil and phenoxymethyl penicillin . Scand J Infect Dis . 1994;:26:59-66.
Pichichero ME, Gooch WM, Rodriguez W, et al.  Effective short-course treatment of acute group A β-hemolytic streptococcal tonsillopharygitis: ten days of penicillin V vs 5 days or 10 days of cefpodoxime therapy in children . Arch Pediatr Adolesc Med . 1994;;148:1053-1060.
Pelc A, Montron A, Ichou F, Portier H.  5 days of cefpodoxime proxetil versus 10 days of penicillin V in adult patients with group A beta-hemolytic streptococcal pharyngitis: a cost-effectiveness analysis . Recent Advances in Chemotherapy: Proceedings of the 18th International Congress of Chemotherapy, Stockholm, Sweden, 1993 . Washington, DC: American Society for Microbiology; 1994;: 588-590.
Searle SR. Linear Models . New York, NY: John Wiley & Sons Inc; 1971;.
Conover WJ. Practical Nonparametric Statistics . 2nd ed. New York, NY: John Wiley & Sons Inc; 1980;.
Coonan KM, Kaplan EL.  In vitro susceptibility of recent North American group A streptococcal isolates to eleven oral antibiotics . Pediatr Infect Dis J . 1994;; 12:630-635.
Craig WA.  Interrelationship between pharmacokinetics and pharmacodynamics in determining dosage regimens for broad-spectrum cephalosporins . Drug Microbiol Infect Dis . 1995;;22:89-96.
Guttendorf R, Koup J, Misiak P, Hawkins P, Olson S. Pharmacokinetics of cefdinir in children. Presented at the 32nd Interscience Conference on Antimicrobial Agents and Chemotherapy; October 14, 1992; Anaheim, Calif. Abstract 1227.
McCracken GH, Ginsburg CM, Clahsen JC, Thomas ML.  Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability . Pediatrics . 1978;;62:738-743.
Pichichero ME, Margolis PA.  A comparison of cephalosporins and penicillins in the treatment of group A beta-hemolytic streptococcal pharyngitis: a meta-analysis supporting the concept of microbial copathogenicity . Pediatr Infect Dis J . 1991;;10:275-281.
Brook I, Gilmore JD.  Evaluation of bacterial interference and β-lactamase production in management of experimental infection with group A beta-hemolytic streptococci . Antimicrob Agents Chemother . 1993;;37:1452-1455.
Shulman ST, Gerber MA, Tanz RR, Markowitz M.  Streptococcal pharyngitis: the case for penicillin therapy . Pediatr Infect Dis J . 1994;;13:1-7.
Denny FW, Wannamaker LW, Brink WR, Rammelcamp CH, Custer EA.  Prevention of rheumatic fever: treatment of the preceding streptococcal infection . JAMA . 1950;;143:151-152.
Chamovitz R, Catanzaro FJ, Stetson CA, Rammelcamp CH.  Prevention of rheumatic fever by treatment of previous streptococcal infection, I: evaluation of benzathine penicillin G . N Engl J Med . 1954;;251:466-471.
Bisno AL.  The concept of rheumatogenic and non-rheumatogenic group A streptococci . In: Read SE, Zabriskie JB, eds. Streptococcal Diseases and the Immune Response . New York, NY: Academic Press Inc; 1980;:789-803.
Aujard Y, Boucot I, Brahimi N, Chiche D, Bingen E.  Comparative efficacy and safety of four-day cefuroxime axetil and ten-day penicillin treatment of group A beta-hemolytic streptococcal pharyngitis in children . Pediatr Infect Dis J . 1995;;14:295-300.

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References

Neu HC, Saha G, Chin NX.  Comparative in vitro activity and β-lactamase stability of FK482, a new oral cephalosporin . Antimicrob Agents Chemother . 1989;; 33:1795-1800.
Wise R, Andrews JM, Thornber D.  The in vitro activity of cefdinir (FK 482), a new oral cephalosporin . J Antimicrob Chemother . 1991;;28:239-248.
Brook I.  Role of beta-lactamase–producing bacteria in the failure of penicillin to eradicate group A streptococci . Pediatr Infect Dis J . 1985;;4:491-495.
Dajani A, Taubert K, Ferrieri P, Peter G, Shulman S.  Treatment of acute streptococcal pharyngitis and prevention of rheumatic fever: a statement for health professionals . Pediatrics . 1995;;96:758-764.
Portier H, Chavanet P, Waldner-Combernoux A, et al.  Five versus ten days treatment of streptococcal pharyngotonsillitis: a randomized controlled trial comparing cefpodoxime proxetil and phenoxymethyl penicillin . Scand J Infect Dis . 1994;:26:59-66.
Pichichero ME, Gooch WM, Rodriguez W, et al.  Effective short-course treatment of acute group A β-hemolytic streptococcal tonsillopharygitis: ten days of penicillin V vs 5 days or 10 days of cefpodoxime therapy in children . Arch Pediatr Adolesc Med . 1994;;148:1053-1060.
Pelc A, Montron A, Ichou F, Portier H.  5 days of cefpodoxime proxetil versus 10 days of penicillin V in adult patients with group A beta-hemolytic streptococcal pharyngitis: a cost-effectiveness analysis . Recent Advances in Chemotherapy: Proceedings of the 18th International Congress of Chemotherapy, Stockholm, Sweden, 1993 . Washington, DC: American Society for Microbiology; 1994;: 588-590.
Searle SR. Linear Models . New York, NY: John Wiley & Sons Inc; 1971;.
Conover WJ. Practical Nonparametric Statistics . 2nd ed. New York, NY: John Wiley & Sons Inc; 1980;.
Coonan KM, Kaplan EL.  In vitro susceptibility of recent North American group A streptococcal isolates to eleven oral antibiotics . Pediatr Infect Dis J . 1994;; 12:630-635.
Craig WA.  Interrelationship between pharmacokinetics and pharmacodynamics in determining dosage regimens for broad-spectrum cephalosporins . Drug Microbiol Infect Dis . 1995;;22:89-96.
Guttendorf R, Koup J, Misiak P, Hawkins P, Olson S. Pharmacokinetics of cefdinir in children. Presented at the 32nd Interscience Conference on Antimicrobial Agents and Chemotherapy; October 14, 1992; Anaheim, Calif. Abstract 1227.
McCracken GH, Ginsburg CM, Clahsen JC, Thomas ML.  Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability . Pediatrics . 1978;;62:738-743.
Pichichero ME, Margolis PA.  A comparison of cephalosporins and penicillins in the treatment of group A beta-hemolytic streptococcal pharyngitis: a meta-analysis supporting the concept of microbial copathogenicity . Pediatr Infect Dis J . 1991;;10:275-281.
Brook I, Gilmore JD.  Evaluation of bacterial interference and β-lactamase production in management of experimental infection with group A beta-hemolytic streptococci . Antimicrob Agents Chemother . 1993;;37:1452-1455.
Shulman ST, Gerber MA, Tanz RR, Markowitz M.  Streptococcal pharyngitis: the case for penicillin therapy . Pediatr Infect Dis J . 1994;;13:1-7.
Denny FW, Wannamaker LW, Brink WR, Rammelcamp CH, Custer EA.  Prevention of rheumatic fever: treatment of the preceding streptococcal infection . JAMA . 1950;;143:151-152.
Chamovitz R, Catanzaro FJ, Stetson CA, Rammelcamp CH.  Prevention of rheumatic fever by treatment of previous streptococcal infection, I: evaluation of benzathine penicillin G . N Engl J Med . 1954;;251:466-471.
Bisno AL.  The concept of rheumatogenic and non-rheumatogenic group A streptococci . In: Read SE, Zabriskie JB, eds. Streptococcal Diseases and the Immune Response . New York, NY: Academic Press Inc; 1980;:789-803.
Aujard Y, Boucot I, Brahimi N, Chiche D, Bingen E.  Comparative efficacy and safety of four-day cefuroxime axetil and ten-day penicillin treatment of group A beta-hemolytic streptococcal pharyngitis in children . Pediatr Infect Dis J . 1995;;14:295-300.

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