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Clinical safety and tolerance of azithromycin in children
1Central Research Division, Pfizer Inc., Groton, CT 06340.
Insights
Azithromycin demonstrated a significantly lower incidence of side-effects, particularly gastrointestinal issues, compared to comparator antibiotics in pediatric clinical trials for common infections. This macrolide antibiotic was well-tolerated across all pediatric age groups.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Antibiotic Safety
Background:
- Azithromycin is a widely used macrolide antibiotic for treating common pediatric infections.
- Evaluating the safety profile of azithromycin in comparison to other antibiotics is crucial for clinical decision-making.
Purpose of the Study:
- To analyze and compare the safety and tolerability of azithromycin versus standard antibiotic regimens in children.
- To assess the incidence and types of side-effects associated with azithromycin treatment in pediatric patients.
Main Methods:
- A pooled safety data analysis from multiple clinical trials involving azithromycin and comparator agents (co-amoxiclav, amoxycillin, penicillin V, erythromycin, dicloxacillin, flucloxacillin).
- Side-effects were assessed for severity and relationship to study drugs within 35 days of therapy initiation.
- Infections studied included otitis media, pharyngitis, and skin infections in pediatric populations.
Main Results:
- Azithromycin treatment resulted in a significantly lower overall incidence of side-effects (7.6%) compared to comparator antibiotics (13.8%; P = 0.001).
- Gastrointestinal side-effects were markedly reduced with azithromycin (5.6%) versus comparators (11.7%; P < 0.001).
- No significant differences in laboratory abnormalities were observed between treatment groups; azithromycin was well-tolerated across all pediatric age groups.
Conclusions:
- Azithromycin exhibits a favorable safety profile in children, with a significantly lower incidence of adverse events compared to several standard antibiotic treatments.
- The reduced occurrence of gastrointestinal adverse events makes azithromycin a well-tolerated option for pediatric infections.
- The safety data supports the use of azithromycin in pediatric patients for otitis media, pharyngitis, and skin infections.
Abstract:
An analysis of the safety data emanating from several clinical trials of the use of azithromycin in children has been undertaken. The studies compared azithromycin with standard regimens of various comparator agents: co-amoxiclav, amoxycillin, penicillin V, erythromycin, dicloxacillin and flucloxacillin, in the treatment of otitis media, pharyngitis and skin infections. Side-effects, based on the investigators' assessments of the severity and possible relationship to the study drugs, were measured within 35 days of the start of therapy. The total number of side-effects reported was significantly lower in the azithromycin-treated patients (46/606; 7.6%) than in the comparator-treated patients (72/523; 13.8%; P = 0.001). Two (0.3%) and five (1.0%) patients, respectively, withdrew from treatment in each group. The most frequently reported side-effects were gastrointestinal with an incidence of 5.6% (34 patients) in the azithromycin group and 11.7% (61 patients) in the comparator group (P < 0.001). The only other organ system with more than 0.5% of subjects reporting side-effects was the skin, with nine (1.5%) patients in the azithromycin and 11 (2.1%) patients in the comparator group complaining of dermatological reactions. Azithromycin was equally well tolerated in children of all ages. Inspection of individual studies showed no significant differences in laboratory test abnormalities between treatment groups. Overall, the most frequently (> or = 1% incidence) reported treatment-related laboratory test abnormalities were changes in neutrophil count (3.2%), lactate dehydrogenase (1.5%), blood urea (1.3%) and potassium (1.2%) in the azithromycin group; and in neutrophil (3.2%) and eosinophil count (2.1%) in the comparator group.(ABSTRACT TRUNCATED AT 250 WORDS)