DIAGN MICROBIOLINFECT DIS 1992;15:8,5S-89S

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Comparison of Two Oral Antibiotics, Roxithromycin and AmoxicUlin Plus Clavulanic Acid, in Lower Respiratory Tract Infections Bertrand Dautzenberg, AndrOs Scheimberg, Christian Blambilla, Philippe Camus, Philippe Godard, Jean Claude Guerin, Etienne Lemarie, Yvonne Rezvani, Martine Rosembaum, Edmond Tuchais, and Benoit Wallaert

In a ranaomized, multicenter, open-label study, 490 ambulatory adult patients with lowe~" respiratory tract infection (LRTI) were randomized to roxithromycin (ROX) 150 mg b.i.d, orally (n = 244) or amoxicillin plus cL~vul, mc acia (AMX +CA) as 500 mg A M X + *,25 rag CA t.i.d orally (n = 24). Cli;',icul results were analyr~',l ;.n 477 patients with acute bronchitis (79%), chronic b:vnchitis (CB) (14%), and pneumonia (7%). There were significantly more patients with underlying disease (cardiovascular diseases, p = 0.045; and alcoholism, p38°C in a previously healthy individual); (b) exacerbations of chronic bronchitis [acute infectious exacerbations with changes in sputum volume and nature (mucopurulent or purulent) and fever >38°C in patients with daily sputum production for at least 3 consecu~-~e n~r, th~ a~d fol tllree consecutive years]; and (c) pneumonia (acute respiratory symptoms, such as cough, pleuritic pain, auscultatory lung abnormalities, purulent sputum, fever ->38°C, and a new pulmonary infiltrate demonstrated radiologically). Patients were excluded from the study if pregnant, had known allergy to macrolldes or ~-lactams, had known serious liver or renal diseases, were receiving treatment with ergot derivatives, had received antibiotic treatment in the 3 days prior to diagnosis, were patients with a poor prognosis, had known active tuberculosis or lung cancer, or had a positive I-HV serology. In addition, patients suspected of atypical pneumonia were excluded because the causative organisms (for example, Legionella spp. and Mycoplasma pneumoniae) are resistant to ~-lactam antibiotics.

Treatment Patients were randomized into two groups: ROX group: ROX 150 mg b.i.d, orally; and AMX+CA group: AMX 500 mg and CA 125 mg t.i.d, orally. Both antibiotics were administered for 7 days in acute bronchitis and for 14 days in acute exacerbations of chronic bronchitis and pneumonia.

Evaluation Patients were assessed for clinical response during treatment (day 3) and at the end of treatment (day 7 or 14). Clinical evaluation was based on general and local symptoms only. No specimens for bacteriologic analysis were required by the protocol. A chest radiograph was obtained if pneumonia was suspected. Chest radiographs were analyzed by two

Statistical Methods The Dunnet and Gent test (one-tailed) was used to test equivalence between treatments. The chi-squared test was used to compare the rates of side effects and side-effect-induced withdrawals between the two treatment groups.

RESULTS A total of 490 adult patients were allocated at random to treatment with either ROX 150 mg b.i.d, orally or AMX + CA 500 + 125 mg t.i.d, orally. Clinical results were analyzed for efficacy and tolerance in 477 patients; 13 patients were lost to follow-up. Patient characteristics are shown in Table 1. The mean age was significantly higher in the ROX group than in the AMX + CA group (50 + 20 years vs 47 + 17 years; p = 0.045, Student's t-test), and there were significantly more patients in the ROX group with underlying disease (cardiovascular disease, p= 0.045; and alcoholism, p65 years (%) Sex (5) Male Female Weight (kg) Mean (range)

AMX + CA

235 50 (18--90) 64 (27) 112 (48) 123 (52)

Underlying diseases (%) Cardiovascular Respiratory Cancer Alcoholism Smokers

p

242 47 45 127 115

(17-90) (19) (53) (48)

66.6 (42-119)

65.6 (39-125)

66 41 4 22 77

49 47 6 4 83

(28) (17) (2) (10) (34)

0.045"

(20) (19) (2) (2) (35)

0.045b NS NS

Comparison of two oral antibiotics, roxithromycin and amoxicillin plus clavulanic acid, in lower respiratory tract infections.

In a randomized, multicenter, open-label study, 490 ambulatory adult patients with lower respiratory tract infection (LRTI) were randomized to roxithr...
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