Clinical Outcomes of Amoxicillin - Clavulanate for 5 Days Verses 10 Days in Children with Acute Otitis Media

30 Mar, 21

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Introduction

Acute otitis media is the most frequently diagnosed illness in children and the most commonly cited indication for antimicrobial treatment

To determine whether limiting antimicrobial treatment to 5 days rather than using the standard 10-day regimen would afford equivalent outcomes and reduce the risk of antimicrobial resistance among children with acute otitis media

Patient Profile

Children of 6 to 23 months of age with acute otitis media

Methods

*90mg of amoxicillin and 6.4 mg of clavulanate per kilogram of body weight

Rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization were measured

Study Outcomes

The primary measure was the percentage of children who had clinical failure after treatment of the index infection.
Secondary measures included symptom burden over the period from day 6 (when placebo use in the 5-day group began) to day 14 of the index episode, rates of recurrence

Results

The mean duration of follow-up was 4.4 months in the 10-day group and 3.9 months in the 5-day group (P = 0.007)

Reduced duration treatment with amoxicillin–clavulanate for 5 days was less effective than standard-duration treatment for 10 days
- Children who were treated with amoxicillin–clavulanate for 5 days were more likely than those who were treated for 10 days to have clinical failure

Figure 1: Clinical failure rates in 5-day group and 10-day group

Children exposed three or more children for 10 or more hours per week showed greater clinical failure rates than among those with less exposure (P = 0.02) and were also greater among children with infection in both ears than among those with infection in one ear (P<0.001)

Table 1: Clinical-Failure Rates for the Index Episode of Acute Otitis Media at or before the End-of-Treatment Visit, According to Selected Characteristics at Entry.

Characteristic	10-Day Group (N = 257) (%)	5-Day Group (N = 258) (%)	P Value
All children (%)	16	34	—
Age at entry			0.94
12–23 mo	13	37
6–11 mo	20	31
Exposure to other children			0.02
No	13	25
Yes	19	40
AOM-SOS score at entry			0.19
≤8	19	37
>8	15	30
Ears affected by otitis media			<0.001
One	8	23
Both	25	44
Degree of tympanic-membrane bulging in worse ear			0.12
Slight or moderate	15	31
Marked	20	39
Estimated severity of illness on the basis of pain and fever history only			0.38
Probably nonsevere	20	26
Probably severe	13	40
No. of significantly unfavorable characteristics			<0.001‡
0	8	22
1	12	26
2	31	52

Table 2: Symptomatic Response in Index Episode of Acute Otitis Media

Measure of Symptomatic Response	5-day group	10-day group	P- value
Mean symptom scores over a period from day 6 to day 14	1.61	1.34	0.07
The mean scores at the day-12-to-14 assessment	1.89	1.20	0.001
% of children whose symptom scores decreased more than 50% (indicating less severe symptoms) from baseline to the end of treatment	80	91	0.003

No significant between-group differences in rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-non-susceptible pathogens were reported

Conclusion

The treatment of acute otitis media with amoxicillin–clavulanate for 5 days afforded less-favorable short-term outcomes than treatment for 10 days
Neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen

Reference

N Engl J Med 2016;375:2446-56.

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