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

• Published in: Diagnostic microbiology and infectious disease Vol. 15; no. 4; pp. 85 - 89
• Main Authors: Dautzenberg, Bertrand, Scheimberg, Andrès, Brambilla, Christian, Camus, Philippe, Godard, Philippe, Guerin, Jean Claude, Lemarie, Etienne, Rezvani, Yvonne, Rosembaum, Martine, Tuchais, Edmond, Wallaert, Benoît
• Format: Journal Article Conference Proceeding
• Language: English
• Published: New York, NY Elsevier Inc 01.05.1992; Elsevier
• Subjects: Acute Disease; Administration, Oral; Adult; Aged; Aged, 80 and over; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Amoxicillin - therapeutic use; Amoxicillin-Potassium Clavulanate Combination; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Bronchitis - drug therapy; Chronic Disease; Clavulanic Acids - administration & dosage; Clavulanic Acids - adverse effects; Clavulanic Acids - therapeutic use; Drug Therapy, Combination - administration & dosage; Drug Therapy, Combination - adverse effects; Drug Therapy, Combination - therapeutic use; Drug Tolerance; Female; Follow-Up Studies; Humans; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Pneumonia - drug therapy; Roxithromycin - administration & dosage; Roxithromycin - adverse effects; Roxithromycin - therapeutic use; Congress; Performance evaluation; Respiratory disease; Treatment efficiency; Multicenter study; Oral administration; Tolerance; Infection; Antibiotic; Treatment; Bacteriosis; Antibacterial agent; Comparative study
• ISSN: 0732-8893; 1879-0070
• DOI: 10.1016/0732-8893(92)90133-E

In a randomized, multicenter, open-label study, 490 ambulatory adult patients withu lower respiratory tract infection (LRTI) were randomized to roxithromycin (ROX) 150 mg b.i.d. orally ( n = 244) or amoxicillin plus clavunalic acid (AMX + CA) as 500 mg AMX + 125 mg CA t.i.d. orally ( n = 24). Clinical results were analyzed in 477 patients withu acute bronchitis (79%), chronic bronchitis (CB) (14%), and pneumonia (7%). There were significantly more patients with underlying disease (cardiovascular diseases, p = 0.045; and alcoholism , p<0.001, and more patients over the age of 65 years ( p=0.045 in the ROX group. Overall clinical efficacy was similar in both groups: 88% (206:235) in the ROX group and 85% (205:242) in the AMX + CA group. Side effects were reported in 67 cases (28%0 in the AMX + CA group and in 21 cases (9%) in the ROX group ( p><0.00010, causing withdrawal in 21 and three cases, respectively ( p<0.001. Thus despite being administered to a significantly older and more ill group of patients with LRTI, roxithromycin was as effective as amoxicillin plus clavunalic acid and better tolerated.