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Short course therapy with cefitbuten versus azithromycin in pediatric streptococcal pharyngitis
A Boccazzi1, P Tonelli, M De'Angelis
1Pediatric Department, University of Milan Medical School, Italy.
Insights
Ceftibuten and azithromycin are effective for treating pediatric strep throat. Ceftibuten showed a higher long-term eradication rate for group A beta-hemolytic streptococcal (GABHS) pharyngitis compared to azithromycin.
Area of Science:
- Pediatric infectious diseases
- Pharmacology
- Microbiology
Background:
- Group A beta-hemolytic streptococcal (GABHS) pharyngitis is common in children.
- Antibiotic resistance is a growing concern, necessitating effective treatment options.
Purpose of the Study:
- To compare the safety and efficacy of a 5-day course of ceftibuten versus a 3-day course of azithromycin for treating GABHS pharyngitis in children.
- To evaluate clinical outcomes and microbiologic eradication rates.
Main Methods:
- A multicenter, open-label, randomized trial involving children aged 3-16 years with confirmed GABHS pharyngitis.
- Patients received either daily ceftibuten for 5 days or azithromycin for 3 days.
- Clinical and microbiologic assessments were performed at multiple follow-up visits.
Main Results:
- Both treatments demonstrated high clinical success rates (98% for ceftibuten, 94% for azithromycin) at 6-8 days post-therapy.
- Bacteriologic eradication rates at 6-8 days were similar (76% for both groups).
- At 33-35 days, ceftibuten achieved higher GABHS-negativity (84%) compared to azithromycin (71%), with lower relapse rates.
Conclusions:
- Both ceftibuten and azithromycin offer convenient, short-duration treatment regimens for pediatric GABHS pharyngitis.
- Ceftibuten demonstrated a potentially superior long-term bacteriologic eradication rate, consistent with the in vitro activity of beta-lactams against GABHS.
- Both antibiotics were well-tolerated, indicating favorable safety profiles.
Objective:
To compare the safety and efficacy of a short course (5 days) of ceftibuten vs. azithromycin for 3 days for treatment of group A beta-hemolytic streptococcal (GABHS) pharyngitis in children.
Methods:
A multicenter, open label, prospective, randomized trial in which patients > or =3 to < or =16 years of age with proven GABHS pharyngitis were randomized to receive either once daily ceftibuten for 5 days or azithromycin for 3 days. Patients were evaluated for clinical outcomes and/or for adverse events at days 6 to 8, 13 to 15 and 33 to 35 posttherapy. Microbiologic assessments (pharyngeal cultures) were conducted at baseline and at each follow-up visit.
Results:
A total of 132 patients in the ceftibuten arm and 116 in the azithromycin arm were enrolled in the safety analysis, whereas 126 and 101, respectively, were enrolled for ceftibuten and azithromycin efficacy evaluation. Clinical success (cure or marked amelioration) at days 6 to 8 was recorded in 98 and 94% in the 2 groups, respectively. In the bacteriologic efficacy analysis at 6 to 8 days, the GABHS strain was eradicated in 76% of the patients treated with ceftibuten and in 76% of those receiving azithromycin. At 33 to 35 days, 84% of the patients in the ceftibuten arm and 71% in the azithromycin arm were GABHS-negative, and bacteriologic relapse was observed in 4 and 7% of the ceftibuten and azithromycin cases, respectively. Both treatments were well-tolerated by all patients.
Conclusions:
Ceftibuten and azithromycin allow simple treatment schedules (i.e. once daily administration, short duration of treatment). The somewhat higher eradication rate recorded after ceftibuten administration is consistent with the overall superior bactericidal activity of beta-lactams compared with macrolides vs. GABHS in vitro.