Is roxithromycin better than amoxicillin in the treatment of acute lower respiratory tract infections in primary care? A double-blind randomized controlled trial

J Fam Pract. 2002 Apr;51(4):329-36.


Objective: To assess the efficacy of roxithromycin relative to amoxicillin.

Study design: 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.

Population: 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.

Outcomes measured: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Amoxicillin / adverse effects
  • Amoxicillin / therapeutic use*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Bronchitis / drug therapy
  • Bronchitis / etiology
  • Double-Blind Method
  • Family Practice
  • Female
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Netherlands
  • Odds Ratio
  • Penicillins / adverse effects
  • Penicillins / therapeutic use*
  • Pneumonia / drug therapy
  • Pneumonia / etiology
  • Respiratory Tract Infections / drug therapy*
  • Respiratory Tract Infections / etiology
  • Roxithromycin / adverse effects
  • Roxithromycin / therapeutic use*


  • Anti-Bacterial Agents
  • Penicillins
  • Roxithromycin
  • Amoxicillin