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Research ArticleOriginal Research

Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care

Nick A. Francis, Matthew J. Ridd, Emma Thomas-Jones, Christopher C. Butler, Kerenza Hood, Victoria Shepherd, Charis A. Marwick, Chao Huang, Mirella Longo, Mandy Wootton and Frank Sullivan; the CREAM Trial Management Group
The Annals of Family Medicine March 2017, 15 (2) 124-130; DOI: https://doi.org/10.1370/afm.2038
Nick A. Francis
1Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, Wales
MD, PhD
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  • For correspondence: francisna@cf.ac.uk
Matthew J. Ridd
2School of Social and Community Medicine, University of Bristol, Bristol, England
PhD
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Emma Thomas-Jones
3South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, Wales
PhD
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Christopher C. Butler
4Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England
FRCGP
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Kerenza Hood
3South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, Wales
PhD
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Victoria Shepherd
3South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, Wales
MA
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Charis A. Marwick
5Population Health Sciences, University of Dundee, Dundee, Scotland
PhD
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Chao Huang
3South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, Wales
PhD
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Mirella Longo
6Swansea Centre for Health Economics, Swansea University, Swansea, Wales
PhD
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Mandy Wootton
7Specialist Antimicrobial Chemotherapy Unit, Public Health Wales, University Hospital Wales, Cardiff, Wales
PhD
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Frank Sullivan
8Department of Family & Community Medicine and Dalla Lana School of Public Health, North York General Hospital, University of Toronto, Toronto, Canada
FRSE
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Tables

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    Table 1

    Baseline Characteristics

    Control (n = 40)Oral Antibiotic (n = 36)Topical Antibiotic (n = 37)Overall (n = 113)
    Age, mean (SD)3.3 (2.2)2.9 (2.2)3.0 (2.1)3.1 (2.1)
    Gender, n (%)
     Male17 (42.5)18 (50.0)17 (45.9)52 (46.0)
     Female23 (57.5)18 (50.0)20 (54.1)61 (54.0)
    Ethnicity, n (%)
     White33 (82.5)31 (86.1)27 (73.0)91 (80.5)
     Mixed4 (10.0)1 (2.8)3 (8.1)8 (7.1)
     Asian, Chinese or other1 (2.5)3 (8.3)3 (8.1)7 (6.2)
     Black2 (5.0)0 (0.0)3 (8.1)5 (4.4)
     Prefer not to answer0 (0.0)1 (2.8)1 (2.7)2 (1.8)
    Duration of eczema flare,a n (%)
     1–3 days3 (12.5)3 (13.0)2 (10.0)8 (11.9)
     4–7 days10 (41.7)9 (39.1)4 (20.0)23 (34.3)
     8–14 days7 (29.2)7 (30.4)5 (25.0)19 (28.4)
     15–28 days4 (16.7)4 (17.4)9 (45.0)17 (25.4)
    Clinical features,b n (%)
     Itchy skin37 (94.9)35 (97.2)35 (94.6)107 (95.5)
     Dry skin37 (94.9)35 (97.2)37 (100)109 (97.3)
     Weeping or oozing skin lesion19 (48.7)20 (55.6)22 (59.5)61 (54.5)
     Crusting27 (69.2)28 (77.8)28 (75.7)83 (74.1)
     Pustules13 (33.3)14 (38.9)7 (18.9)34 (30.4)
     Fever during this illness7 (18.0)10 (27.8)6 (16.2)23 (20.5)
     Painful skin23 (59.0)25 (69.4)31 (83.8)79 (70.5)
     Hypersensitivity of skin26 (66.7)27 (75.0)27 (73.0)80 (71.4)
     Disturbed sleep26 (66.7)28 (77.8)25 (67.6)79 (70.5)
     Feeling generally unwell11 (28.2)15 (41.7)13 (35.1)39 (34.8)
     Interference in normal activities9 (23.1)19 (52.8)18 (48.7)46 (41.1)
    Features of infection, n (%)
     One or more of weeping, crusting, pustules, fever, or painful skin36 (92.3)33 (91.7)35 (94.6)104 (92.9)
     Growth of S. aureus from skin swab16 (60.0)30 (83.3)24 (66.7)78 (69.6)
    Prescribed topical corticosteroids,c  n (%)
     Mild only19 (48.7)16 (45.7)12 (32.4)47 (42.3)
     Moderate only15 (38.5)15 (42.9)16 (43.2)46 (41.4)
     Both mild & moderate5 (12.8)4 (11.4)9 (24.3)18 (16.2)
    • ↵a Missing data for 16, 13, and 17 in the control, oral antibiotic, and topical antibiotic groups respectively.

    • ↵b Number with a score of 1 or more.

    • ↵c Missing data for 1 in control and 1 in oral antibiotic groups.

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    Table 2

    Effect of Oral and Topical Antibiotics on Subjective and Objective Eczema Severity at 2 Weeks, 4 Weeks, and 3 Months

    OutcomeControlOral AntibioticTopical Antibiotic
    NBaseline, Mean (SD)Follow-up, Mean (SD)NBaseline, Mean (SD)Follow-up, Mean (SD)Intervention Effect (95% CI)NBaseline, Mean (SD)Follow-up, Mean (SD)Intervention Effect (95% CI)
    POEM
     2 weeksa3613.4 (5.1)6.2 (6.0)3414.6 (5.3)8.3 (7.3)1.5 (−1.4, 4.4)3116.9 (5.5)9.3 (6.2)1.5 (−1.6, 4.5)
     4 weeks3513.6 (5.0)8.0 (6.0)3314.6 (5.4)8.4 (7.7)−0.2 (−3.1, 2.8)3016.6 (5.4)9.5 (5.9)0.0 (−3.1, 3.1)
     3 months2513.7 (5.1)7.7 (5.5)2814.4 (5.7)7.8 (6.1)−0.2 (−3.1, 2.7)2116.4 (5.5)7.9 (5.6)−1.1 (−4.3, 2.1)
    EASI
     2 weeks345.8 (5.0)2.5 (5.6)347.3 (6.1)3.1 (3.6)0.2 (−0.1, 0.5)319.5 (9.7)4.9 (5.6)0.4 (0.1, 0.8)
      weeks345.8 (5.0)4.0 (6.6)337.4 (6.2)3.2 (3.8)−0.1 (−0.5, 0.2)309.7 (9.8)5.0 (6.9)0.0 (−0.3, 0.4)
    • EASI = Eczema Area and Severity Index (objective eczema severity); POEM = Patient Oriented Eczema Measure (subjective eczema severity).

    • ↵a Primary outcome.

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    Table 3

    Use of Topical Corticosteroids by Treatment Group

    Control n = 36Oral Antibiotic n = 34Topical Antibiotic n = 30
    na (%)Applications/wk, Mean (SD)na (%)Applications/wk, Mean (SD)na (%)Applications/wk, Mean (SD)
    Mild19 (52.8)8.4 (6.6)21 (61.8)7.0 (4.8)15 (50.0)7.1 (4.5)
    Moderate24 (66.7)7.0 (4.1)22 (64.7)6.9 (2.8)24 (80.0)7.3 (3.9)
    Potent2 (5.6)4.0 (2.8)3 (8.8)6.2 (5.3)2 (6.7)8.0 (1.4)
    • ↵a Some participants used corticosteroids of more than 1 potency, so the total number of courses exceeds the number of participants.

Additional Files

  • Tables
  • Supplemental Appendixes 1-10

    Supplemental Appendixes 1-10

    Files in this Data Supplement:

    • Supplemental data: Appendixes 1-10 - PDF file
  • The Article in Brief

    Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care

    Nick A. Francis , and colleagues

    Background This study assesses whether oral or topical antibiotics, in addition to standard treatment with topical corticosteroids, are more effective than placebo in reducing eczema severity in children with clinically infected eczema.

    What This Study Found Estimates suggest that 40 percent of eczema flares are treated with topical antibiotics, but findings from this study suggest there is no meaningful benefit from the use of either oral or topical antibiotics for milder clinically infected eczema in children. There was rapid resolution in response to mild-to-moderate strength topical corticosteroids and emollient treatment; clinically meaningful benefit from the addition of either oral or topical antibiotics was ruled out. Because the study excluded patients with severe infection, the results may not be generalizable to all children with clinically infected eczema.

    Implications

    • The authors conclude that topical antibiotics frequently used in outpatient care, especially in combination products with topical corticosteroids, are not beneficial to patients with clinically infected eczema and can actually promote resistance and allergy or skin sensitization. They suggest that providing or stepping up the potency of topical corticosteroids and emollients should be the main focus in the care of milder clinically infected eczema flares.
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The Annals of Family Medicine: 15 (2)
The Annals of Family Medicine: 15 (2)
Vol. 15, Issue 2
March/April 2017
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Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care
Nick A. Francis, Matthew J. Ridd, Emma Thomas-Jones, Christopher C. Butler, Kerenza Hood, Victoria Shepherd, Charis A. Marwick, Chao Huang, Mirella Longo, Mandy Wootton, Frank Sullivan
The Annals of Family Medicine Mar 2017, 15 (2) 124-130; DOI: 10.1370/afm.2038

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Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care
Nick A. Francis, Matthew J. Ridd, Emma Thomas-Jones, Christopher C. Butler, Kerenza Hood, Victoria Shepherd, Charis A. Marwick, Chao Huang, Mirella Longo, Mandy Wootton, Frank Sullivan
The Annals of Family Medicine Mar 2017, 15 (2) 124-130; DOI: 10.1370/afm.2038
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Subjects

  • Domains of illness & health:
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