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A randomized comparison of two clarithromycin doses for treatment ofMycobacterium avium complex infections

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Two dosages of clarithromycin were compared for treatment of disseminatedMycobacterium avium disease of AIDS patients: high-dose (HD): 1,000 mg or 750 mg b.i.d. according to body weight, and low-dose (LD): 1,000 mg or 750 mg q.d. Patients with high probability ofM. avium positive blood culture on day 0 received a 42-day clarithromycin treatment with HD (n=27) or LD (n=28) at random after stratification according to body weight. Assessment procedures, including quantitative blood cultures, were performed at days 14, 28 and 42. Forty-five patients were eligible for clinical and 28 for bacteriological evaluation. Bacteriological success was observed in 12 HD and 11 LD patients, partial success in one HD and two LD and failure in none of the HD and two LD (p=0.33). Between days 0 and 42, log decreases in CFU counts/ml were (mean ± SD) 3.13±0.82 (HD) and 2.67±1.8 (LD) (p=0.38). Fever and night sweats significantly improved similarly in both groups; no change in spleen and liver size was observed on CT scans. Eight patients died during the study but no death was reported as drug related. Sixteen patients (HD=6, LD=10) discontinued the treatment because of side effects. A trend towards improved bacteriological effectiveness and reduced tolerance was observed in the HD group but the difference was not significant. With a power of 0.70, no dose effect was demonstrated between the two tested dosages. A daily dose of 1,000 mg clarithromycin was tested in drug combinations to treat disseminatedM. avium infection in AIDS patients.

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Authors and Affiliations

  1. Service de Pneumologie, France

    B. Dautzenberg M. D.

  2. Laboratoire Central de Virologie et de Bactériologie, France

    Chantal Truffot-Pernot Ph. D. & J. Grosset M. D.

  3. Service de Radiologie, France

    Catherine Begelman M. D.

  4. Service des maladies infectieuses et tropicales, France

    Géraldine Guermonprez M. D.

  5. Pharmacie Centrale, Groupe Hopitalier Pitié-Salpêtrière, F-75651, Paris Cedex 13

    Marie H. Fievet Ph. D.

  6. Laboratoire Abbott France, Rungis

    J. Hazebroucq M. D. & Sophie Legris M. D.

  7. Pharmacie Centrale, Hôpital Cochin Port-Royal, Paris

    Corinne Guérin Ph. D.

  8. Dépt. de Biostatistiques et d'Informatique Médicale, Hôpital St. Louis, Paris, France

    C. Chastang M. D.

Authors
  1. B. Dautzenberg M. D.
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  2. Chantal Truffot-Pernot Ph. D.
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  3. J. Grosset M. D.
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  4. Catherine Begelman M. D.
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  5. Géraldine Guermonprez M. D.
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  6. Marie H. Fievet Ph. D.
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  7. J. Hazebroucq M. D.
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  8. Sophie Legris M. D.
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  9. Corinne Guérin Ph. D.
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  10. C. Chastang M. D.
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Dautzenberg, B., Truffot-Pernot, C., Grosset, J. et al. A randomized comparison of two clarithromycin doses for treatment ofMycobacterium avium complex infections. Infection 25, 16–21 (1997). https://doi.org/10.1007/BF02113501

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  • DOI: https://doi.org/10.1007/BF02113501

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