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Infection

, Volume 21, Issue 4, pp 272–278 | Cite as

A comparative study of clarithromycin and amoxycillin suspensions in the treatment of pediatric patients with acute otitis media

  • S. J. Coles
Article

Summary

This phase III, single-blind, randomized, multicentre clinical trial compared the safety and efficacy of clarithromycin and amoxycillin in the treatment of otitis media in pediatric patients. Two hundred and fifty-nine patients aged 1–12 were prescribed suspensions of clarithromycin (132 patients) or amoxycillin (127 patients). Both suspensions were prescribed at a dose of 125 mg for children weighing less that 25 kg or at 250 mg for children weighing more than 25 kg, but three doses of amoxycillin per day were given, while only two doses clarithromycin per day were required. Each drug was administered for approximately 5 days. Clinical evaluations were performed pre-treatment (Study Day 1), at the end of treatment (Study Days 6–9), and post-treatment (Study Days 28–32). At the end of treatment, 91 out of 114 evaluable patients (80%) had clinical cures with clarithromycin, while 71 out of 105 evaluable patients (68%) had clinical cures with amoxycillin (p=0.057). Clinical success rates were 96% for both treatments (110/114, clarithromycin; 101/105 amoxycillin). Adverse events related to the study medications occured in four of 132 patients receiving clarithromycin (3%) and eight out of 127 subjects receiving amoxycillin (6%). Three patients discontinued treatment due to adverse events, all three receiving amoxycillin. At the doses administered, clarithromycin given twice-daily was as safe and effective as amoxycillin given three-times-daily in the treatment of acute otitis media in pediatric patients.

Keywords

Pediatric Patient Amoxicillin Otitis Medium Clarithromycin Evaluable Patient 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Vergleichsstudie zur Therapie der akuten Otitis media bei pädiatrischen Patienten mit Clarithromycin oder Amoxicillin in Saftzubereitung

Zusammenfassung

Im Rahmen einer randomisierten, einfach blind geführten, multizentrischen klinischen Studie wurde die Wirksamkeit und Sicherheit von Clarithromycin im Vergleich zu Amoxicillin in der Therapie der akuten Otitis media bei Kindern geprüft. 259 Patienten im Alter von 1–12 Jahren erhielten Clarithromycin (132 Kinder) oder Amoxicillin (127 Kinder) als Saftzubereitung verordnet. Die Dosis betrug bei beiden Medikamenten bei Kindern unter 25 kg Körpergewicht 125 mg und bei Kindern über 25 kg 250 mg. Doch wurden bei Amoxicillin drei Tagesdosen gegeben, während bei Clarithromycin nur zwei Dosen nötig waren. Jedes der beiden Medikamente wurde etwa 5 Tage lang verabreicht. Klinische Untersuchungen wurden vor Therapie (Studientag 1), am Ende der Therapie (Studientage 6–9) und im Anschluß an die Behandlung (Studientage 28–32) vorgenommen. Nach Abschluß der Behandlung mit Clarithromycin waren 91 von 114 auswertbaren Patienten (80%) klinisch geheilt, nach Amoxicillin 71/105 (68%) (p=0,057). Die Gesamtansprechrate betrug bei beiden Therapien 96% (110/114 bei Clarithromycin; 101/105 bei Amoxicillin). Vier der 132 mit Clarithromycin behandelten Patienten (3%) und acht der mit Amoxicillin behandelten Patienten (6%) entwickelten Nebenwirkungen, die mit dem Prüfmedikament in Zusammenhang gebracht wurde. Bei drei Patienten — alle in der Amoxicillingruppe — machten die Nebenwirkungen ein Absetzen der Therapie erforderlich. In der verabreichten Dosierung war Clarithromycin bei zweimal täglicher Gabe in der Behandlung der akuten Otitis media bei pädiatrischen Patienten ebenso sicher und wirksam wie Amoxicillin bei dreimal täglicher Gabe.

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References

  1. 1.
    Machka, K., Braveny, L., Dabernat, H., Dornbusch, K., Van Dyck, E. Kayser, F. H., Van Klingeren, B., Mittermayer, H., Perea, E., Powell, M. Distribution and resistance patterns ofHaemophilus influenzae: a European cooperative study. Eur. J. Clin. Microbiol. Infect. Dis. 7 (1986) 14–24.Google Scholar
  2. 2.
    Appelbaum, P. C. World-wide development of antibiotic resistance in pneumococci. Eur. J. Clin. Microbiol. 6 (1987) 367–377.Google Scholar
  3. 3.
    Fernandes, P. B., Bailer, R., Swanson, R., Hanson, C. W., McDonald, E., Ramer, N., Hardy, D., Shipkowitz, N., Bower, R. R., Gade, E. In vitro andin vivo evaluation of A-56268 (TE-031), a new macrolide. Antimicrob. Agents Chemother. 30 (1986) 865–873.Google Scholar
  4. 4.
    Dabernat, J., Delmas, C., Seguy, M., Fourtillian, J. B., Girault, J., Lareng, M. B. The activity of clarithromycin and its 14-hydroxy metabolite againstH. influenzae, determined byin-vitro and serum bactericidal tests. J. Antimicrob. Chemother. 27 (Suppl A) (1991) 19–30.Google Scholar
  5. 5.
    Hardy, D. J., Swanson, R. N., Rode, R. A., Marsh, K., Shipkowitz, N. L., Clement, J. J. Enhancement of thein vitro andin vivo activities of clarithromycin againstHaemophilus influenzae by 14-hydroxy-clarithromycin, its major metabolite in humans. Antimicrob. Agents Chemother. 34 (1990) 1407–1413.Google Scholar
  6. 6.
    Hardy, D. J., Guay, D. R. P., Jones, R. N. Clarithromycin, a unique macrolide: a pharmacokinetic, microbiological, and clinical overview. Diagn. Microbiol. Infect. Dis. 14 (1992) 39–53.Google Scholar
  7. 7.
    Gan, V. N., Chu, S-Y., Kusmiesz, H. T., Craft, J. C. Pharmacokinetics of a clarithromycin suspension in infants and children. Antimicrob. Agents Chemother. 36 (1992) 2478–2480.Google Scholar
  8. 8.
    Siepman, N., Craft, J. C., Northcutt, V. J., Janousky, S.: Safety of clarithromycin in pediatric patients. The First International Conference on the Macrolides, Azalides, and Streptogramins (ICMAS), Santa Fe, New Mexico; January 22–25, (1992) Abstract 219.Google Scholar
  9. 9.
    Northcutt, V. J., Janousky, S., Craft, J. C.: Safety and efficacy of clarithromycin and amoxycillin or amoxycillin/clavulanate suspensions in the treatment of children with acute otitis media. 8th Mediterranean Congress of Chemotherapy (MCC), Athens, Greece; May 24–29, (1992) Abstract 717.Google Scholar
  10. 10.
    Corder, W. T., DeFeo, N. A., Ferrari, N. D., Moore, R. S., Aronoff, S. C.: Comparative efficacies of clarithromycin and cefaclor in rural children with acute otitis media. Program and abstracts of the 8th Mediterranean Congress of Chemotherapy. (1992) Abstract 716.Google Scholar
  11. 11.
    Bergeron, M. G., Bernier, M., L'Ecuyer, J. In vitro activity of clarithromycin and its 14-hydroxy-metabolite against 203 strains ofHaemophilus influenzae. Infection 20 (1992) 164–167.Google Scholar
  12. 12.
    Akita, H., Sato, Y., Iwata, S., Sunagawa, K. Basic and clinical studies on TE-031 (A-56268) in pediatrics. Japanese Journal of Antibiotics 42 (1989) 264–280.Google Scholar
  13. 13.
    Motohiro, T., Sakata, Y., Kuroiwa, Y., Aramaki, M., Oda, K., et al. Clinical study on clarithromycin granule and tablet in the field of pediatrics. Japanese Journal of Antibiotics 42 (1989) 423–464.Google Scholar
  14. 14.
    Iwai, N., Taneda, Y., Miyazu, M., Nakamura, H., Kasai, K. Basic and clinical studies of clarithromycin in pediatrics. Japanese Journal of Antibiotics 42 (1989) 304–323.Google Scholar
  15. 15.
    Ito, S., Mayumi, M., Mikawa, H. Clinical evaluation of clarithromycin in pediatric patients. Japanese Journal of Antibiotics 42 (1989) 343–352.Google Scholar
  16. 16.
    Meguro, H., Arimasu, O., Hiruma, F., Sugamato, K., Sugie, N., Higa, A., Shinozaki, T., Abe, T. Clinical evaluation of clarithromycin, a new macrolide antibiotic in children. Japanese Journal of Antibiotics 42 (1989) 255–262.Google Scholar

Copyright information

© MMV Medizin Verlag GmbH München 1993

Authors and Affiliations

  • S. J. Coles
    • 1
  1. 1.Abbott Laboratories Limited, Abbott HouseMaidenheadEngland

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