Is roxithromycin better than amoxicillin in the treatment of acute lower respiratory tract infections in primary care? A double-blind randomized controlled trial.
OBJECTIVE
To assess the efficacy of roxithromycin relative to amoxicillin.


METHODS
We conducted a double-blind randomized controlled trial of oral 500 mg amoxicillin 3 times per day vs oral 300 mg roxithromycin once a day for 10 days.


METHODS
We included 196 adults who had presented to a general practitioner with lower respiratory tract infection (LRTI) and, in the physician's opinion, needed antibiotic treatment.


METHODS
We measured clinical response after 10 and 28 days, defined in 4 ways: (1) decrease in LRTI symptoms; (2) complete absence of symptoms; (3) decrease in signs; and (4) complete absence of signs. Self-reported response included the decrease in symptoms and the time until resumption of impaired or abandoned daily activities on days 1 through 10, 21, and 27.


RESULTS
Clinical cure rates after the completion of antibiotic treatment (10 days) were not significantly different for the 2 groups. After 28 days, the roxithromycin group showed no increase in cure rate as evidenced by the decrease in symptoms, indicating a significantly lower cure rate. However, this difference did not alter physicians' overall conclusion after complete follow-up that 90% of patients, regardless of age, had been effectively treated with either amoxicillin or roxithromycin.


CONCLUSIONS
The surplus value of roxithromycin was not confirmed. Amoxicillin remains a reliable first-choice antibiotic in the treatment of LRTI in general practice.
Hopstaken
R M
RM
R.M. Hopstaken, Maastricht University, Dept of General Practice, PO Box 616, 6200 MD Maastricht, The Netherlands. rogier.hopstaken@hag.unimaas.nl
Nelemans
P
P
Stobberingh
E E
EE
Muris
J W M
JW
Rinkens
P E L M
PE
Dinant
G J
GJ
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D005194:Family Practice; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D016017:Odds Ratio; D010406:Penicillins / Q000009:adverse effects / Q000627:therapeutic use*; D011014:Pneumonia / Q000188:drug therapy / Q000209:etiology; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000209:etiology; D015575:Roxithromycin / Q000009:adverse effects / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D010406:Penicillins; D015575:Roxithromycin; D000658:Amoxicillin