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Meta-Analysis
. 2010 Sep 8;2010(9):CD001095.
doi: 10.1002/14651858.CD001095.pub2.

Short-course antibiotics for acute otitis media

Anita Kozyrskyj  1 , Terry P Klassen, Michael Moffatt, Krystal Harvey
Affiliations
Meta-Analysis

Short-course antibiotics for acute otitis media

Anita Kozyrskyj et al. Cochrane Database Syst Rev. .

Abstract

Background: Acute otitis media (AOM) is a common illness during childhood, for which antibiotics are frequently prescribed.

Objectives: To determine the effectiveness of a short course of antibiotics (less than seven days) in comparison to a long course of antibiotics (seven days or greater) for the treatment of AOM in children.

Search strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, issue 4) which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE, EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, CINAHL, BIOSIS Previews, OCLC Papers First and Proceedings First, Proquest Dissertations and Theses (inception to November 2009); International Pharmaceutical Abstracts, the NLM Gateway, ClinicalTrials.gov and Current Controlled Trials (inception to August 2008).

Selection criteria: Trials were included if they met the following criteria: participants aged one month to 18 years; clinical diagnosis of ear infection; no previous antimicrobial therapy; and randomisation to treatment with less than seven days versus seven days or more of antibiotics.

Data collection and analysis: The primary outcome of treatment failure was defined as the absence of clinical resolution, relapse or recurrence of AOM during one month following initiation of therapy. Treatment outcomes were extracted from individual studies and combined in the form of a summary odds ratio (OR). A summary OR of 1.0 indicates that the treatment failure rate following less than seven days of antibiotic treatment was similar to the failure rate following seven days or more of treatment.

Main results: This update included 49 trials containing 12,045 participants. Risk of treatment failure was higher with short courses of antibiotics (OR 1.34, 95% CI 1.15 to 1.55) at one month after initiation of therapy (21% failure with short-course treatment and 18% with long-course; absolute difference of 3% between groups). There were no differences found when examining treatment with ceftriaxone for less than seven days (30% failure in those receiving ceftriaxone and 27% in short-acting antibiotics administered for seven days or more) or azithromycin for less than seven days (18% failure in both those receiving azithromycin and short-acting antibiotics administered for seven days or more) with respect to risk of treatment failure at one month or less. Significant reductions in gastrointestinal adverse events were observed for treatment with short-acting antibiotics and azithromycin.

Authors' conclusions: Clinicians need to evaluate whether the minimal short-term benefit from longer treatment of antibiotics is worth exposing children to a longer course of antibiotics.

PubMed Disclaimer

Conflict of interest statement

None.

Figures

1
1
Funnel plot of comparison: 2 Short‐acting antibiotic > 48 hours short‐term treatment, outcome: 2.1 Treatment failure at 1 month or less.
2
2
Funnel plot of comparison: 21 Ceftriaxone, outcome: 21.1 Treatment failure at 1 month or less.
3
3
Funnel plot of comparison: 23 Azithromycin 3 to 5 days short‐term treatment, outcome: 23.1 Treatment failure at 1 month or less.
1.1
1.1. Analysis
Comparison 1 Short‐acting antibiotic =< 48 hours in short treatment arm, Outcome 1 Treatment failure at 1 month or less.
2.1
2.1. Analysis
Comparison 2 Short‐acting antibiotic > 48 hours short‐term treatment, Outcome 1 Treatment failure at 1 month or less.
2.2
2.2. Analysis
Comparison 2 Short‐acting antibiotic > 48 hours short‐term treatment, Outcome 2 Treatment failure at 8 to 19 days.
2.3
2.3. Analysis
Comparison 2 Short‐acting antibiotic > 48 hours short‐term treatment, Outcome 3 Treatment failure at 20 to 30 days.
2.4
2.4. Analysis
Comparison 2 Short‐acting antibiotic > 48 hours short‐term treatment, Outcome 4 Treatment failure at 3 months or less.
2.5
2.5. Analysis
Comparison 2 Short‐acting antibiotic > 48 hours short‐term treatment, Outcome 5 Treatment failure at 90 days.
2.6
2.6. Analysis
Comparison 2 Short‐acting antibiotic > 48 hours short‐term treatment, Outcome 6 Treatment failure at 30 to 45 days.
3.1
3.1. Analysis
Comparison 3 Short‐acting antibiotic > 48 hours short‐term treatment, < 2 yrs old, Outcome 1 Treatment failure at 1 month or less.
4.1
4.1. Analysis
Comparison 4 Short‐acting antibiotic > 48 hours short‐term treatment, => 2 yrs old, Outcome 1 Treatment failure at 1 month or less.
5.1
5.1. Analysis
Comparison 5 Short‐acting antibiotic > 48 hours short‐term treatment, perforated eardrum, Outcome 1 Treatment failure at 1 month or less.
6.1
6.1. Analysis
Comparison 6 Short‐acting antibiotic > 48 hours short‐term treatment, non‐perforated eardrum, Outcome 1 Treatment failure at 1 month or less.
7.1
7.1. Analysis
Comparison 7 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity Analysis: include chronic OM, Outcome 1 Treatment failure at 1 month or less.
7.2
7.2. Analysis
Comparison 7 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity Analysis: include chronic OM, Outcome 2 Treatment failure at 20 to 30 days.
8.1
8.1. Analysis
Comparison 8 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity Analysis: exclude chronic OM, Outcome 1 Treatment failure at 1 month or less.
8.2
8.2. Analysis
Comparison 8 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity Analysis: exclude chronic OM, Outcome 2 Treatment failure at 20 to 30 days.
9.1
9.1. Analysis
Comparison 9 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: outcome only if "cured", Outcome 1 Treatment failure at 1 month or less.
9.2
9.2. Analysis
Comparison 9 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: outcome only if "cured", Outcome 2 Treatment failure at 20 to 30 days.
10.1
10.1. Analysis
Comparison 10 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: same antibiotic in treatment arms, Outcome 1 Treatment failure at 1 month or less.
10.2
10.2. Analysis
Comparison 10 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: same antibiotic in treatment arms, Outcome 2 Treatment failure at 8 to 19 days.
10.3
10.3. Analysis
Comparison 10 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: same antibiotic in treatment arms, Outcome 3 Treatment failure at 20 to 30 days.
10.4
10.4. Analysis
Comparison 10 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: same antibiotic in treatment arms, Outcome 4 Treatment failure at 3 months or less.
10.5
10.5. Analysis
Comparison 10 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: same antibiotic in treatment arms, Outcome 5 Treatment failure at 90 days.
10.6
10.6. Analysis
Comparison 10 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: same antibiotic in treatment arms, Outcome 6 Treatment failure at 30 to 45 days.
11.1
11.1. Analysis
Comparison 11 Short‐acting antibiotic > 48 hours short‐term treatment, excluding amoxicillin‐clavulanate, Outcome 1 Gastrointestinal adverse effects.
12.1
12.1. Analysis
Comparison 12 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: treatment failure at 1 month or less and risk of bias, Outcome 1 Sensitivity analysis: allocation concealment unclear risk of bias.
12.2
12.2. Analysis
Comparison 12 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: treatment failure at 1 month or less and risk of bias, Outcome 2 Sensitivity analysis: allocation concealment low risk of bias.
12.3
12.3. Analysis
Comparison 12 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: treatment failure at 1 month or less and risk of bias, Outcome 3 Sensitivity analysis: blinding high and unclear risk of bias.
12.4
12.4. Analysis
Comparison 12 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis: treatment failure at 1 month or less and risk of bias, Outcome 4 Sensitivity analysis: blinding low risk of bias.
13.1
13.1. Analysis
Comparison 13 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis amoxil‐clav. both arms, Outcome 1 Amoxil‐clav. 5 versus 10 days, treatment failure 1 month or less.
13.2
13.2. Analysis
Comparison 13 Short‐acting antibiotic > 48 hours short‐term treatment; Sensitivity analysis amoxil‐clav. both arms, Outcome 2 Excluding amoxil‐clav. 5 versus 10 days, treatment failure 1 month or less.
14.1
14.1. Analysis
Comparison 14 Short‐acting antibiotic > 48 hours short‐term treatment, => 2 yrs old; Sensitivity analysis, Outcome 1 Treatment failure at 1 month or less.
15.1
15.1. Analysis
Comparison 15 Short‐acting antibiotic > 48 hours short‐term treatment, < 2 yrs old; Sensitivity analysis, Outcome 1 Treatment failure at 1 month or less.
16.1
16.1. Analysis
Comparison 16 Short‐acting antibiotic, > 48 hours short‐term treatment, adverse GI effects, Outcome 1 Gastrointestinal adverse effects.
17.1
17.1. Analysis
Comparison 17 Ceftriaxone, Outcome 1 Treatment failure at 1 month or less.
17.2
17.2. Analysis
Comparison 17 Ceftriaxone, Outcome 2 Treatment failure at 3 months or less.
17.3
17.3. Analysis
Comparison 17 Ceftriaxone, Outcome 3 Gastrointestinal adverse effects.
18.1
18.1. Analysis
Comparison 18 Azithromycin single‐dose short‐term treatment, Outcome 1 Treatment failure at 25 to 32 days.
18.2
18.2. Analysis
Comparison 18 Azithromycin single‐dose short‐term treatment, Outcome 2 Treatment failure at 25 to 32 days, =< 2 yrs old.
18.3
18.3. Analysis
Comparison 18 Azithromycin single‐dose short‐term treatment, Outcome 3 Treatment failure at 25 to 32 days, > 2 yrs old.
18.4
18.4. Analysis
Comparison 18 Azithromycin single‐dose short‐term treatment, Outcome 4 Gastrointestinal adverse effects.
19.1
19.1. Analysis
Comparison 19 Azithromycin 3 to 5 days short‐term treatment, Outcome 1 Treatment failure at 1 month or less.
19.2
19.2. Analysis
Comparison 19 Azithromycin 3 to 5 days short‐term treatment, Outcome 2 Treatment failure at 8 to 19 days.
19.3
19.3. Analysis
Comparison 19 Azithromycin 3 to 5 days short‐term treatment, Outcome 3 Treatment failure at 20 to 30 days.
20.1
20.1. Analysis
Comparison 20 Azithromycin 3 to 5 days short‐term treatment, < 2 years old, Outcome 1 Treatment failure at 1 month or less.
21.1
21.1. Analysis
Comparison 21 Azithromycin 3 to 5 days short‐term treatment, => 2 years old, Outcome 1 Treatment failure at 1 month or less.
22.1
22.1. Analysis
Comparison 22 Azithromycin 3‐5 days short‐term treatment; Sensitivity analysis: include chronic OM, Outcome 1 Treatment failure at 1 month or less.
22.2
22.2. Analysis
Comparison 22 Azithromycin 3‐5 days short‐term treatment; Sensitivity analysis: include chronic OM, Outcome 2 Treatment failure at 20 to 30 days.
23.1
23.1. Analysis
Comparison 23 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: exclude chronic OM, Outcome 1 Treatment failure at 1 month or less.
23.2
23.2. Analysis
Comparison 23 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: exclude chronic OM, Outcome 2 Treatment failure at 20 to 30 days.
24.1
24.1. Analysis
Comparison 24 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: outcome only if "cured", Outcome 1 Treatment failure at 1 month or less.
24.2
24.2. Analysis
Comparison 24 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: outcome only if "cured", Outcome 2 Treatment failure at 20 to 30 days.
25.1
25.1. Analysis
Comparison 25 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: similar spectrum antibiotic in treatment arms, Outcome 1 Treatment failure at 20 to 30 days.
25.2
25.2. Analysis
Comparison 25 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: similar spectrum antibiotic in treatment arms, Outcome 2 Treatment failure at 1 month or less.
26.1
26.1. Analysis
Comparison 26 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: risk of bias, Outcome 1 Sensitivity analysis: allocation concealment unclear or high risk of bias.
26.2
26.2. Analysis
Comparison 26 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: risk of bias, Outcome 2 Sensitivity analysis: allocation concealment low risk of bias.
26.3
26.3. Analysis
Comparison 26 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: risk of bias, Outcome 3 Sensitivity analysis: blinding high and unclear risk of bias.
26.4
26.4. Analysis
Comparison 26 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: risk of bias, Outcome 4 Sensitivity analysis: blinding low risk of bias.
27.1
27.1. Analysis
Comparison 27 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: industry funding, Outcome 1 Treatment failure 1 month or less.
27.2
27.2. Analysis
Comparison 27 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: industry funding, Outcome 2 Treatment failure at 8 to 19.
27.3
27.3. Analysis
Comparison 27 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: industry funding, Outcome 3 Treatment failure at 20 to 30 days.
28.1
28.1. Analysis
Comparison 28 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: funding not reported, Outcome 1 Treatment failure 1 month or less.
28.2
28.2. Analysis
Comparison 28 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: funding not reported, Outcome 2 Treatment failure at 8 to 19 days.
28.3
28.3. Analysis
Comparison 28 Azithromycin 3 to 5 days short‐term treatment; Sensitivity analysis: funding not reported, Outcome 3 Treatment failure at 20 to 30 days.
29.1
29.1. Analysis
Comparison 29 Azithromycin 3 to 5 days short‐term treatment, adverse GI effects, Outcome 1 Gastrointestinal adverse effects.
30.1
30.1. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 1 Twice counting ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure at 1 month or less.
30.2
30.2. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 2 Combined control groups ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure 1 month or less.
30.3
30.3. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 3 Twice counting ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure at 1 to 19 days.
30.4
30.4. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 4 Combined control groups ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure 1 to 19 days.
30.5
30.5. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 5 Twice counting ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure 20 to 30 days.
30.6
30.6. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 6 Combined control groups ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure at 20 to 30 days.
30.7
30.7. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 7 Twice counting ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure at 30 to 40 days.
30.8
30.8. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 8 Combined control groups ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure 30 to 40 days.
30.9
30.9. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 9 Twice counting ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure at 3 months or less.
30.10
30.10. Analysis
Comparison 30 Methods ‐ combined control group versus twice counting tx, Outcome 10 Combined control groups ‐ short‐acting antibiotic > 48 hours short‐term treatment, treatment failure at 3 months or less.
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Update of

References

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    1. Rodriguez AF. An open study to compare azithromycin with cefaclor in the treatment of children with acute otitis media. Journal of Antimicrobial Chemotherapy 1996;37(Suppl C):63‐9. - PubMed
Schaad 1993 {published data only}
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Varsano 1988 {published data only}
    1. Varsano I, Frydman M, Amir J, Alpert G. Single intramuscular dose of ceftriaxone as compared to 7‐day amoxicillin therapy for acute otitis media in children. Chemotherapy 1988;34(Suppl 1):39‐46. - PubMed
Varsano 1997 {published data only}
    1. Varsano I, Volovitz B, Horev Z, Robinson J, Laks Y, Rosenbaum I, et al. Intramuscular ceftriaxone compared with oral amoxicillin‐clavulanate for treatment of acute otitis media in children. European Journal of Pediatrics 1997;156(11):858‐63. - PubMed
Wang 2004 {published data only}
    1. Wang CY, Lu CY, Hsieh YC, Lee CY, Huang LM. Intramuscular ceftriaxone in comparison with oral amoxicillin‐clavulanate for the treatment of acute otitis media in infants and children. Journal of Microbiology, Immunology & Infection 2004;37(1):57‐62. - PubMed

References to studies excluded from this review

Bain 1985 {published data only}
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Gehanno 1990 {published data only}
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Harrison 1993 {published data only}
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Jacobson 1979 {published data only}
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Jenner 1987 {published data only}
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Johnson 1991 {published data only}
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MacLouglin 1996 {published data only}
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Mandel 1995 {published data only}
    1. Mandel EM, Casselbrant ML, Rockette HE, Bluestone CD, Kurs‐Lasky M. Efficacy of 20‐ vs. 10‐day antimicrobial treatment for acute otitis media. Pediatrics 1995;96:5‐13. - PubMed
Murph 1993 {published data only}
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O'Doherty 1996 {published data only}
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Roos 2000 {published data only}
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Rubenstein 1965 {published data only}
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Scott 1990 {published data only}
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Simon 1997 {published data only}
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Spencer 1993 {published data only}
    1. Spencer RC, Hannington J, Fraser S, Mason T. Cefpodoxime proxetil versus co‐amoxiclav in the treatment of acute infections of the ear, nose and throat in children‐a multicentre randomized study. Antibiotic Abstract 851. 18th International Congress of Chemotherapy (June 27 ‐ July 2). Stockholm, Sweden, 1993:264.
Stickler 1964 {published data only}
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Stickler 1967 {published data only}
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Suzuki 2009 {published data only}
    1. Suzuki K, Baba S, Totsuka K, Hori S, Ubukata K, Nakashima M, et al. Double‐blind comparative study of tebipenem pivoxil and high‐dose cefditoren pivoxil in children with acute otitis media. Japanese Journal of Chemotherapy 2009;57(Suppl 1):167‐85.
Varsano 1994 {published and unpublished data}
    1. Varsano I, Volovitz B, Horev Z, Robinson J, Laks Y, Rosenbaum I, et al. Single IM dose of ceftriaxone (CRO) compared to 10 days amoxicillin‐clavulanate augmentin (AUG) for therapy of acute otitis media (AOM) in children. Sixth International Congress for Infectious Disease. Czech Republic, 1994; Vol. Session 117:1059.

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References to other published versions of this review

Kozyrski 1998
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