3-day Treatment with Azithromycin (10 mg/kg per day once daily), A Promising Alternative Therapy for Tonsillitis in Children
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2 Jun, 20

Introduction

Tonsillitis is the most common upper respiratory infection disease in children, mainly caused by Group A ?-hemolytic streptococcus (GAS)infection. Azithromycin is a type of macrolide antibiotic and used for the treatment of varieties of bacterial infections, including pharyngitis and tonsillitis.

Aim

To evaluate and compare the clinical efficacy of azithromycin (10 mg/kg per day once daily for 3 days) or cefaclor (20 mg/kg per day in 3 divided doses for 5 days)

with amoxicillin (30 mg/kg per day in 3 divided doses for 10 days), for the treatment of tonsillitis in children.

Patient Population

  • N=256 children
  • aged between 2 and 12 years
  • signs and symptoms of tonsillitis
  • The children were diagnosed with tonsillitis by the presence of a sore throat and (or) a swollen, hyperemic, or suppurated tonsil and (or) visible secretions or erythema of tonsil and (or) with fever

Methods

  • Each patient was scheduled for the follow-up for the clinical and bacteriologic assessment on day 14 and day 30 from the start of the treatment
    • The signs and symptoms were observed, and the tonsils swab cultures were conducted for the bacteriological examination
    • Blood sample and urinalysis were performed to determine the safety and the complication of the drug for the patients
  • Clinical and Bacteriological assessments were conducted
    • The therapeutic efficacy was evaluated as success or failure on day 14 from the start of the treatment according to the clinical symptoms
    • The clinical success was defined by the improvement of signs and symptoms and the disappearance of fever, such that no additional drugs were needed for the therapy
    • The therapy failure was defined by the lack of improvement in clinical symptoms, which needed additional antibiotic therapy
    • The first bacteriologic outcome was defined as eradication or failure by a pharyngeal/tonsil swab culture on day 14, soon after completion of therapy
    • The success of microbiologic evaluation was defined by the eradication of the pathogen identified by a pharyngeal/tonsil swab culture
    • The secondary microbiologic outcome was evaluated on day 30 among patients designated microbiologic successes on day 14 and with the follow-up at day 30, which was classified as eradication and recurrence (the reappearance of the pathogen

Results

 Table 1: Baseline characteristics

 

p

Azithromycin vs.

Azithromycin vs.

Cefaclor vs.

Variable

Azithromycin

Cefaclor

Amoxicillin

cefaclor

amoxicillin

amoxicillin

No. of patients

85

88

83

 

 

 

Age (years)

5.6±2.3

5.8±2.3

5.9±2.4

0.568a

0.409a

0.781a

Sex (male/female)

40/45

49/39

45/38

0.257b

0.354b

0.847b

Mass (kg)

20.6±7.1

22.1±7.8

20.9±6.4

0.188a

0.774a

0.273a

Duration of infection before treatment (days)

2.1±0.7

2.2±0.9

2.3±1.0

0.416a

0.135a

0.493a

aStudent’s t-test.

b x2 test.

Clinical Efficacy and Microbiologic Outcome

  • At the end of therapy (day 14) and microbiologic results at follow-up (day 30)
  • There was no statistical difference, but a tendency toward more chance of therapeutic improvement in patients treated with azithromycin in comparison with those treated with cefaclor and amoxicillin was observed
 Table 2:  Clinical efficacy and microbiologic outcome

Clinical efficacy and

microbiologic outcome

No. of patients (%)

P

Azithromycin vs.

Azithromycin vs.

Cefaclor vs.

Azithromycin

Cefaclor

Amoxicillin

Cefaclor

amoxicillin

amoxicillin

Clinical Efficacy

n=83

n=79

n=78

 

 

 

Success

80 (96.4)

73 (92.4)

71 (91.0)

0.3198a

0.2002a

0.7538b

Failure

3 (3.6)

6 (7.6)

7 (9.0)

 

 

 

Microbiologic outcome at 14 day

n=83

n=79

n=78

 

 

 

Eradication

78 (94.0)

71 (89.9)

69 (88.5)

0.3367b

0.2146b

0.7759b

Failure

5 (6.0)

8 (10.1)

9 (11.5)

 

 

 

Microbiologic results at day 30

n=77

n=71

n=68

 

 

 

Eradication

75 (97.4)

66 (93.0)

64 (94.1)

0.261a

0.419a

0.947b

Failure

2 (2.6)

5 (7.0)

4 (5.9)

 

 

 

aFisher’s exact test.

bx2 test.

Figure 1: Clinical cure and Eradication Rate at the end of 14 day

 Safety

  • The adverse events occurrence rate in the azithromycin treatment group was lower than those in the other 2 groups (p = 0.030 and p = 0.029)
  • No significant difference was observed between cefaclor and amoxicillin groups (p = 0.977)
  • Azithromycin treatment showed lower occurrence rate of adverse events than the other 2 groups
Table 3: Adverse events experienced by the patients

 

No. of patients (%)

P

 

Azithromycin vs.

cefaclor

Azithromycin vs.

amoxicillin

Cefaclor vs.

amoxicillin

 

Variable

Azithromycin

Cefaclor

Amoxicillin

 

Adverse events

n=83

n=80

n=79

 

 

 

 

Diarrhea

1 (1.2)

2 (2.5)

4 (5.1)

0.616a

0.202a

0.443a

 

Rash

0 (0)

5 (6.3)

2 (2.5)

0.027a

0.236a

0.443a

 

Nausea

1 (1.2)

2 (2.5)

3 (3.8)

0.616a

0.358a

0.358a

 

Total events

2 (2.4)

9 (11.3)

9

(11.4)

0.030a

0.029a

0.977b

 

aFisher’s exact test

b X2 test

Conclusion

  • The study demonstrated that azithromycin showed a better tendency of clinical efficacy and microbiologic outcome with lower recurrence of bacteria and less adverse events compared with the other 2 groups
  •  The three groups showed no statistical difference for the clinical effectiveness and bacterial elimination, however, there was a tendency that azithromycin treatment is more effective than the cefaclor and amoxicillin treatments with a lower occurrence rate of adverse reactions
  • The findings indicated 3-day treatment with azithromycin (10 mg/kg per day once daily) is a promising alternative for therapy of tonsillitis in children caused by GAS

Reference

Can J Physiol Pharmacol.2019;97(10):939-944