Paediatric Respiratory Reviews 15 (2014) 231236

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Paediatric Respiratory Reviews

Clinical Usefulness

Rational use of antibiotics for the management of childrens

respiratory tract infections in the ambulatory setting: an
evidence-based consensus by the Italian Society of Preventive
and Social Pediatrics
Elena Chiappini 1,*, Rachele Mazzantini 1, Eugenia Bruzzese 2, Annalisa Capuano 3,
Maria Colombo 4, Claudio Cricelli 5, Giuseppe Di Mauro 6, Susanna Esposito 7,
Filippo Festini 1, Alfredo Guarino 2, Vito Leonardo Miniello 8, Nicola Principi 7,
Paola Marchisio 7, Concetta Rafaniello 3, Francesco Rossi 3, Liberata Sportiello 3,
Francesco Tancredi 9, Elisabetta Venturini 1, Luisa Galli 1, Maurizio de Martino 1
1
Department of Health Sciences, Paediatric Section, Anna Meyer Childrens University Hospital, Florence, Italy
2
Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples
3
Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Second University of Naples, Naples, Italy
4
Primary care Pediatrician, Milan, Italy
5
Health Search Institute, Italian College of General Practitioners, Florence, Italy
6
President Italian Society of Preventive and Social Pediatrics Primary care Pediatrician, Caserta, Italy
7
Department of Pathophysiology and Transplantation, Pediatric Clinic 1, Universita` degli Studi di Milano, Fondazione IRCCS Ca Grande Ospedale Maggiore
Policlinico, Via Commenda 9, 20122, Milan, Italy
8
Department of Pediatrics, University of Bari Aldo Moro, Bari, Italy
9
Epidemiology Unit, AUSL Naples 1, Italy

EDUCATIONAL AIMS

 Provide an easy to read, evidence based document on the management of respiratory tract infections in a pediatric ambulatory
setting
 Facilitate uniform clinical practice in the treatment of airway infections in children
 Promote a rational use of antibiotics in the management of respiratory tract infections in children

A R T I C L E I N F O S U M M A R Y

Key words: Background: Several guidelines forthemanagement ofrespiratory tractinfections in children areavailable in
Respiratory tract infections
Italy, as well as in other European countries and the United States of America. However, poor adherence to
Children
guidelines and the sustained inappropriate use of antibiotics have been reported. In the outpatient setting,
Guidelines
Antibiotics almost half of antibiotics are prescribed for the treatment of common respiratory tract infections. In Italy the
antibiotic prescription rate is signicantly higher than in other European countries, such as Denmark or the
Netherlands, and also the levels of antibiotic resistance for a large variety of bacteria are higher.
Therefore, the Italian Society of Preventive and Social Paediatrics organised a consensus conference
for the treatment of respiratory tract infections in children to produce a brief, easily readable, evidence-
based document.
Methods: The conference method was used, according to the National Institute of Health and the
National Plan Guidelines. A literature search was performed focusing on the current guidelines for the
treatment of airway infections in children aged 1 month-18 years in the ambulatory setting.
Results: Recommendations for the treatment of acute pharyngitis, acute otitis media, sinusitis, and
pneumonia have been summarized. Conditions for which antibiotic treatment should not be routinely
prescribed have been highlighted.
Conclusion: This evidence-based document is intended to accessible to primary care pediatricians and
general practice physicians in order to make clinical practice uniform, in accordance with the
recommendations of the current guidelines.
2013 Elsevier Ltd. All rights reserved.

* Corresponding author.

1526-0542/$ see front matter 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.prrv.2013.11.011
232 E. Chiappini et al. / Paediatric Respiratory Reviews 15 (2014) 231236
BACKGROUND
A variety of guidelines for the management of respiratory tract
infections in children are available in Italy, as well as in other
European countries and the USA; however, poor adherence to
guidelines and sustained inappropriate use of antibiotics have been
reported [113]. Antibiotics remain the most frequently prescribed
drugs for children across European countries, even though
quantitative and qualitative differences in prescription proles
have been documented [14,15]. Of note, in the outpatient setting, is
that almost half of the antibiotics prescribed are for the treatment of
common upper respiratory tract infections despite the fact that
these are often self-limiting viral conditions, not benetting from
antibiotic therapy [1518]. Similarly, the wait and see strategy,
currently recommended for the management of acute otitis media in
children above two years of age, has not been largely adopted by the
European pediatricians [19]. In Italy the antibiotic prescription rate
is signicantly higher compared with other European countries,
such as Denmark or The Netherlands, with higher prescription rates
observed in southern than in northern regions [14,2022]. Accord-
ingly, in 2011, Italy was among the European countries with the
highest levels of antibiotic resistance for a wide variety of bacteria
[23]. Educational campaigns promoting the rational use of
antibiotics have been demonstrated to be effective in improving
physician behavior [2426]. A recent meta-analysis of the inter-
ventions to inuence antibiotic use for acute respiratory tract
infections in children, involving 23 studies, conrmed that in order
to be most effective interventions should provide concise written
materials with focused guidance on specic diseases, and should
employ a delayed prescribing strategy when appropriate [25].
Following these suggestions, the Italian Society of Preventive and
Social Pediatrics, jointly with the Italian Society of Pediatric
Infectious Diseases, other Scientic Societies (listed in the acknowl-
edgments section), and a parents association, formed a consensus
conference to produce a brief, easily readable, evidence-based
document that could be used for immediate and quick reference in
the ambulatory setting, for the treatment of respiratory tract
infections in children. The main objective was to promote the
rational use of antibiotics, focusing on the appropriate agent, dosage
and route of administration. In particular, antibiotics for viral
conditions (e.g. inuenza), as well as the use of wide-spectrum
agents as rst-choice therapy and intramuscular administration, are
discouraged. The document was sent to primary care pediatricians
and general practitioners, and disseminated through websites and
conference meetings.
METHODS
This document is directed toward the treatment of infection of
the airways in children aged 1 month to 18 years in the pediatric
ambulatory setting. It does not include denitions of the diseases
Table 1
Strength of evidence and grade of recommendation
Strength of evidence
(Muir Gray)
I Evidence obtained from more than one randomised controlled clinical trial and/or from
systematic reviews of randomised trials
II Evidence obtained from a single randomised, controlled and soundly designed clinical trial
III Evidence obtained from well designed not randomized, cohort studies, case control studies,
controlled trials, from comparative studies
IV Evidence obtained from retrospective studies, such as case-control studies
or their meta-analysis
Va Evidence based on opinions of renowned experts
Vb Evidence based on expert committees, as indicated in guidelines or by
consensus conferences
treated, and neither does it cover treatment in newborns, in the
hospital setting or in non-Western countries [27]. The Consensus
Conference method was used, following the National Institutes of
Health and the National Plan Guidelines [28,29]. In a rst step, the
Organizing Committee carried out a systematic review of the
relevant scientic literature and an analysis of Italian and
international guidelines. Specic clinical questions were then
identied. Subsequently, the clinical questions, the bibliographical
material and a preliminary draft of the document were provided to
the panel members. In the various meetings, the speakers
explained to the panel the evidence relating to the clinical
questions, focusing mainly on the content of the most recent
national and international guidelines. The grading of the strength
of evidence and level of recommendation were decided by
reference to the diagram of Muir Gray and Cook (Table 1) [30].
The Delphi method [28] was used when the evidence did not
provide consistent and unambiguous recommendations in answer
to the clinical question. The nal text was changed on the basis of
these discussions and submitted by e-mail to participants at the
Consensus Conference for nal approval.
A literature review of the Cochrane Librarys databases, Medline
and PubMed was performed using an appropriate search strategy.
Checklists and predened tables were used to assess study quality
and to extract data in a standard way [3]. The recommendations
were based on scientic evidence available until March 7, 2013.
The panel will be taking up the issue again in two years, and will
promote a new consensus conference if clinically relevant evidence
has emerged from new studies on the rational use of antibiotic
therapy for acute infections of the airways in children.
SUMMARY OF THE RECOMMENDATIONS
Treatment of acute pharyngitis
When should antibiotics be used? How soon after the onset of
symptoms should the therapy be started?
Group A b-hemolytic Streptococcus is responsible for about
30% of pharyngitis cases in childhood. The diagnosis and treatment
of streptococcal pharyngitis is crucial in order to reduce the risk of
early and late complications [24,31].
The signs and symptoms of streptococcal pharyngitis overlap
extensively with those from other infectious causes. Therefore,
clinical data only are insufcient to formulate an etiological
diagnosis. A rapid test should be performed in the absence of signs
and symptoms suggestive of viral infection. The rapid test must be
performed correctly and can be run only once and with a single
swab. The clinical scoring systems available are not sufcient to
identify with reasonable certainty infections by group A b-
hemolytic Streptococcus. A low score (zero or one) on the McIsaac
system can be used to exclude a streptococcal infection, if there is a
low prevalence of rheumatic disease (A-III).
Grade of recommendation
(Cook)
A Supported by I level of evidence; strongly recommended
B Supported by II level of evidence; recommended
C Supported by III level of evidence; may be taken into
consideration for different clinical actions
D Supported by IV and V levels of evidence
 E. Chiappini et al. / Paediatric Respiratory Reviews 15 (2014) 231236 233

Table 2
Treatment strategies for uncomplicated acute otitis media*

Diagnosis

Bilateral Monolateral

Severe Mild Severe Mild

Age <6 months Immediate antibiotics Immediate antibiotics Immediate antibiotics Immediate antibiotics
Age 624 months Immediate antibiotics Immediate antibiotics Immediate antibiotics Watchful waiting
Age >24 months Immediate antibiotics Watchful waiting Watchful waiting Watchful waiting
*
Absence of otorrhea, intracranial complications or a history of recurrences.

The swab should be vigorously scrubbed on the oropharynx and
on the surface of both tonsils. The physician should avoid touching
other parts of the oral cavity and contaminating with saliva (A-III).
The child needs to be cooperative or immobilized with the help of a
second person (e.g. parent). The pharynx must be adequately
illuminated with electric light and the tongue must be held down
with a tongue depressor (A-VI). Before execution of the rapid test
disinfectants of the oral cavity should not be used.
A throat swab culture is not a routine exam for the diagnosis of
acute pharyngitis caused by group A b-hemolytic Streptococcus.
Antibiotic therapy is recommended in the proven presence of
streptococcal infection in order to reduce the risk of early and late
complications (A-I). The treatment should be prescribed at the
time of diagnosis or up to 9 days after the onset of symptoms, since
this delay is not associated with any increase in the risk of
complications, treatment failure or recurrence (C-I) [24,31].
acute otitis media, and without severe symptoms, or those aged
between 6 months and 2 years with the unilateral form and
symptoms that are not serious (C-I). Watchful waiting should be
evaluated in each case and shared with parents. This can only be
applied in cases where there is the possibility of follow-up (by
telephone and/or clinical) within 48-72 hours (A-I). In the absence
of evidence, the choice of method of contact within 48-72 hours
and the use of a delayed antibiotic prescription is left to medical
judgment, based on the clinical context (A-I) (Table 2) [57].
Which antibiotic should be used for the treatment of acute otitis
media?
Recommended antibiotics according to the childs age and
clinical features are listed in Table 3 [57].
Macrolides or cephalosporins can be used in children with
demonstrated allergy to penicillin [32].

Which antibiotics should be used? What is the administration route
and how long is it?
 Penicillin V is not available in Italy; accordingly amoxicillin
(50 mg/kg/day in 2-3 doses orally) for 10 days is the rst choice
of treatment.
 Benzathine penicillin may be administered in noncompliant
cases (children <30 kg, 600,000 IU; children 30 kg, 1,200,000 IU
[as a single intramuscular dose]).
 Although not recommended routinely because of their high cost
and wide spectrum of activity, a 5-day treatment course with a
second-generation cephalosporin (cefaclor 40 mg/kg/day in 2
doses; cefuroxime axetil 2030 mg/kg/day in 2 doses; or
cefprozil 1530 mg/kg/day in 2 doses) may be used in
noncompliant cases (B-I).
 Macrolide use should be limited to children with demonstrated
immediate or type I hypersensitivity to penicillin, given the high
prevalence of macrolide-resistant strains (C-II). If possible we
must demonstrate the sensitivity of the streptococcus to this
class of antibiotics.
What is the optimal amoxicillin regimen?
The administration of 2 doses of amoxicillin alone or
amoxicillin + clavulanic acid is recommended in children at low
risk of colonization (as indicated in Table 3) by resistant
Streptococcus pneumoniae, while administration in 3 doses is
recommended in high-risk situations (A-II) [57].
What is the optimal duration of antibiotic therapy?
Antibiotic therapy is recommended for 10 days in children at
risk of unfavorable developments (<2 years and/or with sponta-
neous otorrhea). The duration of therapy can be reduced to 5 days
in children > 2 years without the risk of unfavorable evolution (C-I)
[57].
Treatment of rhinosinusitis
Which antibiotic should be used in the treatment of mild
rhinosinusitis, and when?
Antibiotic therapy for mild acute rhinosinusitis (Table 4) is
recommended in order to obtain a more rapid resolution of

Treatment of acute otitis media

Table 3
When is an immediate antibiotic treatment recommended? Antibiotic choices for acute otitis media
Immediate antibiotic therapy is always recommended in
Clinical features Recommended Alternative
patients with bilateral acute otitis media under the age of 2 years,
in subjects with severe symptoms, in those with spontaneous Mild symptoms Amoxicillin Cefaclor
No otorrhea (50 mg/kg/day (40-50 mg/kg/day
perforation and in those with a history of recurrence (A-I). No recent recurrences in 2-3 doses) in 2 doses)
Antibiotic treatment is reasonably advisable in subjects with No risk factors*
severe symptoms, younger than 2 years, in whom, after completing Severe symptoms Amoxicillin + Cefuroxime axetil
all diagnostic procedures, there is still no certainty of acute otitis Otorrhea clavulanic acid (30 mg/kg/day
Recent recurrences (80-90** mg/kg/day in 2 doses)
media (C-Va) (Table 2) [57].
Risk factors* in 2-3 doses) Cefpodoxime proxetil
(8 mg/kg/day
What are the benets of watchful waiting and when should it be used? in 2 doses)
Watchful waiting is the abstention from antibiotic prescription *
Risk factors for bacterial resistance: age <3 years, day-care attendance, older
for the rst 48-72 hours after diagnosis of acute otitis media. It can siblings, recent antibiotic therapy (<1 month).
be applied to children older than 2 years with unilateral or bilateral **
The dosage refers to amoxicillin.
234 E. Chiappini et al. / Paediatric Respiratory Reviews 15 (2014) 231236

Table 4 For how long is the antibiotic therapy recommended?

Symptoms of acute mild and severe rhinosinusitis
Mild Severe
rhinorrhea high fever (> 39 8C)
daytime cough impairment of the general state
no fever or low-grade fever purulent rhinorrhea
halitosis cough day and night
orbital edema (exceptional) orbital edema
headache
halitosis
symptoms. This condition should be treated orally with amoxicillin
at a dose of 50 mg/kg/day, thrice daily. Amoxicillin should be
replaced with amoxicillin + clavulanic acid (80-90 mg/kg/day in 3
doses), cefuroxime axetil (30 mg/kg/day in 2 doses) or cefaclor
(50 mg/kg/day in 2 doses) in patients treated with antibiotic
therapy in the previous 90 days, in children who attend
community day-care, or in children who have local or general
disease which favors infection by germs resistant to antibiotics (C-
III) [8,9].
Which antibiotic should be used in the treatment of severe
rhinosinusitis, and when?
Antibiotic therapy for severe acute rhinosinusitis is mandatory
in order to cure the disease and to prevent the possible occurrence
of complications. Severe acute uncomplicated disease can be
treated with oral amoxicillin + clavulanic acid (80-90 mg/kg/day
(amoxicillin), in 3 doses). The switch to injection therapy and
possible hospitalization should be anticipated after 48-72 hours
when there is no improvement (C-III). Severe acute complicated
rhinosinusitis requires hospitalization. The following antibiotics
may be considered: ceftriaxone (100 mg/kg/day in a single dose),
cefotaxime (100 mg/kg/day in 3 doses), ampicillin + sulbactam
(100 mg/kg/day (ampicillin), in 3 doses), amoxicillin + clavulanic
acid (100 mg/kg/day,s aoxicillin), in 3 doses) [8,9].
Therapy is recommended for 10-14 days for mild acute
rhinosinusitis and for 14-21 days for severe acute rhinosinusitis
(C-III) [810].
Treatment of community-acquired pneumonia
When are antibiotics recommended for the treatment of pediatric
community-acquired pneumonia, in the ambulatory setting?
The hospital treatment of severe pneumonia is well coded. In
contrast, the rational approach to the ambulatory treatment of
mild-to-moderate pneumonia is often based on the opinions of
experts, and the available evidence is particularly low with regard
to younger subjects [11,12]. There is therefore an urgent need for
further studies to better dene the management of mild-to-
moderate pneumonia, especially in children of pre-school age.
Based on the limited data available, we suggest the following
approach: no immediate antibiotic treatment is recommended in
children (particularly pre-school children immunized with
pneumococcal conjugate vaccine) with a mild disease who can
be closely followed up, and for whom all the available
epidemiological, clinical, laboratory and radiological data
strongly suggest a viral infection. However, a diligent follow-up
should be ensured and timely revaluation is recommended.
Antibiotic treatment remains recommended in all other situations
(C-III) [11,12].
Which antibiotics should be used and what is the recommended route
of administration?
Antibiotics recommended, according to the childs age, are
summarized in Table 5 [3438].
How long to treat?
A treatment duration of 5-7 days is recommended for mild or
moderate forms. Prolonged therapy (8-14 days) should be
considered in severe and/or complicated cases and in the event

Table 5
Recommended therapy in children with community-acquired pneumonia (11)

Age Antibiotic choice

recommended treatment alternative treatment

1-3 months^ Oral amoxicillin or intravenous ampicillin (50-90 mg/kg/day in 2-3
doses)
* Clarithromycin oral or intravenous (15mg/kg/day in 2 doses orally
or 4-8 mg/kg/day in 2 doses iv) for 10-14 days or oral azithromycin
(10mg/kg/day in 1 dose for 3 days) or erythromycin (40 mg/kg/day in
3-4 doses)
3 months - 5 years Oral amoxicillin or intravenous ampicillin (50-90 mg/kg/day in 2-3
doses) for 7-10 days (5-7 days may be adjusted)
5-18 years Oral amoxicillin or intravenous ampicillin (50-90 mg/kg/day in 2-3
doses) for 7-10 days (5-7 days may be adjusted)
* Clarithromycin oral or intravenous (15mg/kg/day in 2 doses orally
or 4-8 mg/kg/day in 2 doses ev) for 10-14 days or oral azithromycin
(10 mg/kg/day in 1 dose for 3 days) or erythromycin (40 mg/kg/day in
3-4 doses)
Oral amoxicillin + clavulanic acid (amoxicillin 50-90 mg/kg/day in
2 doses) for 7-10 days (5-7 days may be adjusted) Benzylpenicillin iv
200,000 U/kg/day in 4-6 doses, intravenous ceftriaxone (50 mg/kg
1 dose per day) or intravenous cefotaxime (100-150 mg/kg/day in
3 doses)
Oral amoxicillin + clavulanic acid (amoxicillin 50-90 mg/kg/day in
2 doses) for 7-10 days (5-7 days may be adjusted)
Cefuroxime axetil (30 mg/kg/day in 2 doses) Benzylpenicillin iv
200,000 U/kg/day in 4-6 doses, intravenous ceftriaxone (50 mg/kg
1 time per day) or intravenous cefotaxime (100-150 mg/kg/day in
3 doses)
Cephalexin oral, intravenous cloxacillin, cefazolin and vancomycin,
erythromycin oral or iv (40 mg/kg/day in 3-4 doses) or clarithromycin
oral or iv (4-8 mg/kg/day IV in 2 doses or 15mg/kg/day orally in
2 doses) for 10-14 days or oral azithromycin (10mg/kg/day in 1 dose
for 3 days)
Benzylpenicillin ev 200,000 U/kg/day in 4-6 doses, intravenous
ceftriaxone (50 mg/kg 1 time per day) or intravenous cefotaxime
(100-150 mg/kg/day in 3 doses) or cefalexine oral or intravenous
cloxacillin or cefazoline or vancomycin

^ In children under 6 weeks, treatment with azithromycin, clarithromycin should be advised. Cases of hypertrophic pyloric stenosis as well as of torsades de pointes have been
reported in children who received erythromycin. * In the case of suspected infection by Mycoplasma pneumoniae, Chlamydia pneumoniae or Bordetella pertussis. Staphylococcus
aureus is unusual; if hemoculture or pleural uid culture are positive for S. aureus we can add oxacillin, or we recommend vancomycin in areas with methicillin-resistant S.
aureus.
 E. Chiappini et al. / Paediatric Respiratory Reviews 15 (2014) 231236
Table 6
Conditions in which the use of antibiotics is discouraged [33]
acute rhinitis
acute laryngotracheitis
laryngitis ipoglottica
bronchiolitis
bronchial asthma
u and u-like symptoms
of suspected infection with Mycoplasma pneumoniae (B-II)
[9,10,3841].
CONCLUSIONS
Despite wide dissemination, guidelines may have had limited
efcacy in changing physician behavior in clinical practice.
Potential barriers to guideline adherence include poor guideline
awareness, parental pressure to receive antibiotics, difculty in
obtaining a microbiological diagnosis in children, inertia of
previous practice [25]. Moreover, to date, primary care pedia-
tricians have been faced with a variety of Italian and interna-
tional guidelines, sometimes with contrasting key messages,
requiring substantial time and effort to be analyzed and
followed. Our consensus is a quick, readable, evidence-based
document, which could be easily accessed and followed by
primary care pediatricians and general practice physicians in
order to make clinical practice consistent with the current
recommendations (Table 6).
FUTURE RESEARCH DIRECTIONS
Further promotion of the rational use of antibiotics in children
is required, to ensure paediatricians adherence to guidelines.
Acknowledgments
Italian Society of Preventive and Social Pediatrics; Italian
Society of Pediatric, Infectious Diseases; the Clinical Section of the
Italian Society of Pharmacology; Italian Society of General
Medicine; Italian Society of Pediatric Nursing Sciences; the
parents association Movimento Italiano Genitori.
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