Document 0335
 DOCN  M9460335
 TI    Initial clarithromycin monotherapy for Mycobacterium
       avium-intracellulare complex lung disease.
 DT    9408
 AU    Wallace RJ Jr; Brown BA; Griffith DE; Girard WM; Murphy DT; Onyi GO;
       Steingrube VA; Mazurek GH; Department of Microbiology, University of
       Texas Health Center,; Tyler 75710.
 SO    Am J Respir Crit Care Med. 1994 May;149(5):1335-41. Unique Identifier :
       AIDSLINE MED/94228079
 AB    Sputum conversion rates in Mycobacterium avium-intracellulare (MAI)
       complex lung disease have ranged from only 50 to 80% despite the use of
       three to five antituberculosis agents. We initiated a prospective, open,
       noncomparative trial of initial clarithromycin monotherapy at 500 mg
       twice a day for 4 months in HIV-negative patients with MAI lung disease.
       The primary study end point was microbiologic improvement. Of 30
       patients enrolled, 20 completed therapy. This latter group was
       predominantly male (60%), smokers (70%), older than 45 yr of age (90%),
       infected with Mycobacterium intracellulare (70%) and with bilateral
       disease (85%). Of 19 patients with pretreatment minimum inhibitory
       concentrations (MIC) for clarithromycin < 16 micrograms/ml, 58% became
       sputum-negative, and 21% showed significant reductions in sputum
       positivity. Heavily positive sputum cultures (> 200 colonies) were
       reduced from 30 to 47 samples pretherapy (64%) to three of 54 (6%)
       post-therapy (p < 0.0001); 18 of 19 patients (95%) showed an improvement
       in sputum cultures, chest radiographs, or both. Only two patients (7%)
       discontinued the drug because of adverse events. Only three (16%) of 19
       isolates developed clarithromycin resistance (MIC > 32 micrograms/ml).
       Clarithromycin-susceptible and -resistant MAI isolates from the same
       patient had identical DNA large-restriction fragment patterns.
       Clarithromycin is the first single agent to be shown efficacious in the
       treatment of MAI lung disease.
 DE    Adult  Aged  Aged, 80 and over  Clarithromycin/ADVERSE
       EFFECTS/*THERAPEUTIC USE  Female  Human  Male  Microbial Sensitivity
       Tests  Middle Age  Mycobacterium avium Complex/DRUG EFFECTS/ISOLATION &
       PURIF  Mycobacterium avium-intracellulare Infection/*DRUG THERAPY/
       MICROBIOLOGY  Prospective Studies  Sputum/MICROBIOLOGY  Support,
       Non-U.S. Gov't  Tuberculosis, Pulmonary/*DRUG THERAPY/MICROBIOLOGY
       CLINICAL TRIAL  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).