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M9460335.TXT
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1994-06-12
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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).