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PHARMACIE GLOBALE INTERNATIONAL JOURNAL OF COMPREHENSIVE

PHARMACY COMPARISON OF SINGLE-DOSE CEFTRIAXONE VERSUS SEVEN
DAYS CEFADROXIL IN ADDITION TO FUCIDIC ACID CREAM AS ADJ....

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 Al-Samman D K / Pharmacie Globale (IJCP) 2013, 09 (04)

Available online at www.pharmacie-globale.info ISSN 0976-8157

Research Article
PHARMACIE GLOBALE
INTERNATIONAL JOURNAL OF COMPREHENSIVE PHARMACY

COMPARISON OF SINGLE-DOSE CEFTRIAXONE VERSUS SEVEN DAYS CEFADROXIL IN

ADDITION TO FUCIDIC ACID CREAM AS ADJUVANT THERAPY FOR THE TREATMENT OF
CHILDREN WITH IMPETIGO
Dina K Al-Samman*
Department of Pharmacology, College of Pharmacy, University of Mosul, Mosul, Iraq.
Received: 2 November 2013; Revised: 26 November 2013; Accepted: 1 December 2013; Available online: 5 December 2013

ABSTRACT
Objective of the current research is to compare the efficacy of short-course antibiotic therapies composed of
single intramuscular injection of ceftriaxone versus seven days cefadroxil suspension in addition to adjuvant
fusidic acid cream with the aim of achieving higher cure rates in impetigo, in a shorter time and to increase
compliance to therapy by using single dose. In addition, determining better and improved treatment option
for impetigo, resolving the soreness and the unsightly appearance, especially on the face. As well as
preventing recurrence and spread to other people. Diagnosis of impetigo was made clinically by
dermatologist and experienced family physicians, at Al-qudis health center for family medicine in Mosul city.
Enrollment criteria were to include 2-10 years of age with a clinical diagnosis of non-bullous moderate
impetigo with 11-20 lesions. Children with mild impetigo or who had extensive skin involvement, cellulite,
hypersensitivity to penicillin, cephalosporin or fusidic acid cream were excluded. Also exclude patients who
were immunocompromised, body temperature >38.5°C or who had used topical or systemic antibiotics in
the previous 48hrs. Enrolled children were randomly assigned to 2 groups that received either single dose
ceftriaxone injection IM (50mg/kg/day) (group A) or cefadroxil suspension (30 mg/kg/day) in divided
doses every 12 hours for 7days (group B). In addition to systemic therapy, both groups received topical
treatment consisted of 20g fusidic acid cream mixed with 5g hydrocortisone cream (1%) as adjuvant
therapy. The patients were monitored on days 3 and 8. Patients were considered cured clinically if the
lesions resolved during therapy and did not recur within 10 days up to 1month following discontinuation of
the antibiotic. A total of 52 children were enrolled in the study. On day 3 of therapy, 22/25 children in the
group A (88%) had a cure or excellent response compared with 20/24 children in group B (83%) who had
the same response. On day 8 after therapy, 25/25 children in group A and 24/24 patients in group B who
completed the treatments were cured. Both types of therapy showed clinical successes and proved safe at
end of treatment. There was no relapse in the children reporting after the final visit, for about1 month after
therapy. Statistical analysis by the chi-square test showed no significant differences in outcome between
groups. A short-course treatments with single-dose I.M ceftriaxone, has comparable clinical cure rate to 7-
days cefadroxil .The single dose regimen is a good choice for children who might refuse take or vomit oral
medications and for families who might have compliance problems. Fusidic acid-steroid combination
products are useful for treating impetigo. Parents were universally pleased with the outcome and ease of
using the topical mixed cream as well as it was well-tolerated. The use of a dual therapy of both systemic and
topical antibiotic is recommended for rapid and effective treatment of impetigo with very few side effects.
Keywords: Ceftriaxone; Cefadroxil; Impetigo; Short-course antibiotic therapy; Adjuvant therapy.

INTRODUCTION
Impetigo (pyoderma) is a highly contagious bacterial skin
infection caused by the Gram-positive bacteria
Staphylococcus aureus and sometimes by Streptococcus
pyogenes.1,2 It is the fourth most common dermatological
skin disorders in children seen in general practice which
affects children 2 to 6 years of age and infants, although it
can occur in any age group.3,4
*Corresponding Author:
Dina K Al-Samman
Lecturer, Department of Pharmacology,
College of Pharmacy, University of Mosul, Mosul, Iraq.
Contact no: +7701807610; Email: raheek_3@yahoo.ca
Impetigo can occur as a primary infection or secondary to
pre-existing skin conditions, such as eczema, scabies,
insect bites, or burns. Although it commonly occurs when
bacteria enter the skin through cuts or insect bites, it can
also develop in skin that's perfectly healthy.2,5,6 Impetigo is
highly contagious and can spread easily, in schools and
child care settings, from person to person primarily by
direct contact with infected lesions, and indirectly via
fomites.3,7 It tends to affect exposed areas, such as the face
especially around a child's nose, mouth and extremities.2,8
The diagnosis usually is made clinically, mostly by general

1 Pharmacie Globale© (IJCP), Vol. 04, Issue 09

 Al-Samman D K / Pharmacie Globale (IJCP) 2013, 09 (04)

practitioners and family physician. It is seldom serious, follow common hygienic measures to help keep the
and it may clear on their own in two to three weeks.9,10 But infection from spreading to others, by:
because it can sometimes lead to fatal complications such  Washing patient's linens and towels after the first day of
as acute renal failure, it should be promptly treated to treatment; clothing should be changed and laundered
hasten its resolution.11,12 daily for the first few days, and don't share them with
There is some uncertainty regarding the optimal anyone else in the family.
 Wearing gloves when applying the mixed cream to the
treatment of impetigo. Some recommend oral antibiotic
treatment, others local antibiotic treatment, or even just lesion and wash hands thoroughly afterward.
 Encourage the patient not to touch patches of impetigo,
disinfection in mild cases, so doctors have many treatment
options. It is unclear whether topical or systemic do not allow other children to touch them, to wash
antibiotics are more effective, or indeed there is potential hands frequently, cutting nails short and to use of
conflict between what is in the best interest of the personal towels.
individual patient, and what would best benefit the The patients were monitored on days 3 and 8 and
community in terms of cost and effectiveness of evaluated for:
antibiotic.9,13,14 a) The morphologic structure of the lesions, the grades
The aim of the study is to evaluate and compare the were as follows:
efficacy of short-course antibiotic therapies composed of Cured, the patients were considered clinically “cure” as
single intramuscular injection of ceftriaxone versus seven the target lesions were completely absence or the
days cefadroxil suspension in addition to adjuvant fusidic lesions having become dry and without crusts.
acid cream with the aim of achieving higher cure rates in Remaining local redness of intact skin was acceptable.
impetigo, in a shorter time and to increase compliance to Improved, a decline in affected area, number of lesions
therapy by using single dose. In addition, determining or both, in addition to reduction in the signs and
better and improved treatment option for impetigo, symptoms of infection.
resolving the soreness and the unsightly appearance, Failure, there was little or no reduction in the signs
especially on the face. As well as preventing recurrence and symptoms of infection.
and spread to other people. In cases of incomplete cure, the number and
localization of the persisting lesions were recorded for
PATIENTS AND METHOD follow up.
Diagnosis of impetigo was made clinically by b) The appearance of new lesions (parents were
dermatologist and experienced family physician, at Al- instructed to look for new lesions)
qudis health center for family medicine in Mosul city. c) Adverse events, classified as:
Impetigo lesions are primary superficial infection of Mild, causing minimal discomfort, and not interfering
previously normal skin. Lesions had honey colored in everyday activities.
drainage with crusting on a red base. Enrollment criteria Moderate, causing discomfort and interfere with
were to include 2-10 years of age with a clinical diagnosis normal everyday activities.
of non-bullous moderate impetigo with 11-20 lesions. Severe, incapacitating and preventing normal everyday
Children with mild impetigo (1-10 lesions) or who had activities requiring therapeutic intervention or
extensive skin involvement (more than 20 discrete discontinuation of the study regimen.
lesions), cellulite, and hypersensitivity to penicillin, Patients were considered cured clinically if the lesions
cephalosporin or fusidic acid cream were excluded. Also resolved during therapy and did not recur within 10 days
exclude patients who were immunocompromised, body up to 1 month following discontinuation of the antibiotic.
temperature >38.5°C or who had used topical or systemic
antibiotics in the previous 48hours.
RESULTS AND DISCUSSION
A total of 52 children were enrolled in the study. Three
The following data were recorded: duration of impetigo, patients (1 from group A and 2 from group B) were not
nature of the lesions (redness, crusts, pustules and able to return for the first follow-up examination and
painfulness), number of lesions, their localisation and therefore, were excluded from the study. The remaining
estimated area, body temperature, recent use of 49 patients consisted of 20 males (41%) and 29 females
antibiotics, demographic data, and pre-existence of (59%). Their ages ranged 2 - 9 years. Of these 49 patients,
eczema. 25 patients were in group A and the other 24 patients
Enrolled children were randomly assigned to 2 groups were in group B. The demographics and sites of infection
that received either single dose ceftriaxone injection IM of the two treatment groups are described in Table 1.
(50mg/kg/day) (group A) or cefadroxil suspension (30 Table 1. Demographic data of enrolled patients
Group A Group B
mg/kg/day) in divided doses every 12 hours for 7days Characteristics
N=25 N = 24
(group B). In addition to systemic therapy, both groups Sex distribution
received topical treatment consisted of 20g fusidic acid Male 11 9
cream mixed with 5g hydrocortisone cream (1%) as Female 15 14
adjuvant therapy. Mean age (years) 4.6 (SD 2.1) 5.2 (SD 1.9)
Attending daycare centers/school 18 15
As impetigo is contagious (it can be passed on by Mean body temperature (°C) 36.7(± SD 0.6) 36.8(±SD 0.7)
touching), parents of children in both groups were Mean duration of impetigo before 8.9(SD 6.2) 7.8(7.5)
instructed to wash the skin lesions gently with treatment(days)
antibacterial soap (ActivexR) and running water twice Site(s) of infection*
Face/neck 21 20
daily to remove any crusts and then the combined cream
Limbs 11 9
applied to the lesion twice daily (and on to each nostrils at Trunk 6 5
night time) for 7days or until the lesion had disappeared, Diameter of lesion(Range (mm)) 3 - 35 4 – 30
by using cotton swabs. Moreover, they were instructed to *In some patients more than one site was infected.
2 Pharmacie Globale© (IJCP), Vol. 04, Issue 09
 Al-Samman D K / Pharmacie Globale (IJCP) 2013, 09 (04)
Both groups were comparable with respect to baseline
characteristics.
Children were seen on day 3 of therapy and after the end
of therapy on day 8. Clinical responses were reported at
each visit. The criterion for judging the effectiveness of
treatment was the complete resolution or significant
improvement of clinical signs in clinically evaluable
patients with no changes in the treatment regimen. Also
treatment tolerability and compliance were assessed
retrospectively by questioning the parents. At the first
visit 22/25 children in the group A (88%) had a cure or
excellent response, compared with 20/24 children in
group B (83%) who had the same response. Two patients
in each group had an improvement of lesions but they
were show appearance of new lesions. There was no
therapy failure in both groups (Table 2).
Table 2. The clinical response to the treatment
regimens on 3 and 8 days
Determination Clinical response
Group A Group B
(n = 25) (n =24)
First visit
Cure/excellent response
Improved response
22 20
3 4
Failure response
0 0
Follow up
Cure response 25 24
Failure response 0 0
Relapse 0 0
On day 8 after therapy, 25/25 children in group A, who
completed the treatments were cured. Also 24/24 patients
in group B were cured. Three patients in each group were
not come to the second visit but they were showed cure
from the first follow up. Six patients from group B stop the
cefadroxil suspension before the seventh days; however
they showed clinical improvement in both follow up visits.
Parents were universally pleased with the outcome and
ease of using the topical mixed cream as well as it was
well-tolerated. Although it is greasy and its application
was somewhat messy but did not stain clothing and there
were no complaints.
Both types of therapy showed clinical successes and
proved safe at end of treatment. Although, Ceftriaxone
injection was associated with pain in all patients in group
A, but it was more tolerated than cefadroxil suspension by
parents in the treatment of impetigo because of once time
administration and exclude GIT upset. Totally, all patients
in both groups suffering from pain and burning while
using antibacterial soap and removing crusts. However, no
child suffering from itching while using the combined
cream. Six children (24%) in the group B had diarrhea. All
episodes were mild and none required a change in
therapy.
There was no relapse in the children reporting after the
final visit, for about 1 month after therapy. Statistical
analysis by the chi-square test showed no significant
differences in outcome between groups.
Impetigo is the fourth most common dermatological skin
disorder seen in general practice affecting children
worldwide. There is no standard treatment for impetigo,
and many options are available. As it is contagious, and
sometimes outbreaks occur in families or in people who
live in close communities, proper hygiene and adequate
treatment supposedly control the infection.15
Although impetigo usually heals spontaneously without
treatment after 2-3 weeks, treatment improves cosmetic
3 Pharmacie Globale© (IJCP), Vol. 04, Issue 09
appearance and get rid the unsightly aspect of impetigo as
soon as possible, may be the strongest motive to start
treatment. Especially when the lesions appear on face
which is the most common area affected with impetigo.
Moreover, treatment helps relieve the discomfort as well
as prevent the spread of an organism that may cause other
illnesses.16,17 Aside from curing the individual, the fourth
rationale for treatment could be to reduce the time that a
patient can infect other patients, thus preventing further
spread or epidemics.18,19 Especially schools are interested
in this and may demand that a child is treated or even
cured before it can return to school again. The patient can
return to work or school within 24 hours of starting AB
therapy.
For these reasons, immediate antibiotic treatment is
advised for most cases to achieve a quick cure and prevent
spread of the infection to other parts of the body as well as
to other people.20 An ideal treatment should be effective,
cheap, easy to use, and accepted by people. It should be
free from side effects. Since in clinical practice, it is not
routine to obtain cultures of skin lesions in children
presenting with uncomplicated pyoderma, the study
inclusion was based on clinical diagnosis.
This is the first study that compare parenteral antibiotic
with oral antibiotic medication, in addition to topical
cream and antiseptic soap as adjuvant therapy for treating
impetigo. The result of our study, which were very
encouraging and was associated with fewer side effects,
had showed that no significant differences between single
dose of I.M ceftriaxone injection and 7 days cefadroxil
suspension. Therapy was well accepted by caretakers, and
there was a trend toward an earlier response with this
dual therapy.
Parenteral antibiotic treatment especially if it is a single
dose, provides advantages for children who might refuse
to take or vomit oral medications and for families who
might have compliance problems.21 Ceftriaxone is a safe
and effective antibiotic for the treatment of infections
caused by S. aureus in children.22 Our results support the
findings of other studies that shorter treatments may be
comparable to the traditional 10 days of antibiotic
therapy. It has been reported that many parents only
continue antibiotic therapy until symptoms resolve or by
an additional one or two days.23-24 Moreover, the clinical
success of single-dose IM ceftriaxone for treatment of
impetigo was comparable to the successful treatment of
acute otitis media with single-dose ceftriaxone injection
which was significantly better than ten-day oral
amoxicillin in children.25
Single dose of ceftriaxone should not be recommended for
routine therapy for impetigo because this may enhance
resistance to this potent antibiotic and interfere with its
use in serious and life-threatening infections.20 On the
other hand, Intraglutael injections to the infants should be
prohibited and health workers trained to give necessary
injections in the thigh.26 For this reason, children aged
below 2 years were excluded.
In this study, the response to treatment was more rapid
than that in previous studies. In the first visit, the cure rate
was 88% in group A and 83% in group B whereas the cure
rate on day 8 was 100% in both groups. This excellent
response might be due to the use of combination therapy
of both systemic and topical treatment. While in other
studies the cure rate was different. Koning et al. reported
cure rate of only 55% after 7 days of treatment with
 Al-Samman D K / Pharmacie Globale (IJCP) 2013, 09 (04)
fusidic acid cream only.27 Whereas Goldfarb et al. showed
that the cure rate in all of the children in the mupirocin
group was 80% and in erythromycin group was 43%.28
Oral antibiotic treatment has long been first choice,
because of better treatment results. Cefadroxil, the oral
antibiotic which used in this study, carries an advantage
over other first-generation agents by having a longer
elimination half-life and higher concentrations in skin
blister fluid relative to serum for at least 6 hours after an
oral dosage, which permits once or twice daily
administration. For this reason, the cefadroxil dosage in
this study is lower than that recommended for currently
available oral cephalosporins which must be given on a
four times daily schedule. So that, patients’ compliance
may be better. Another advantage of cefadroxil is that its
absorption is unaffected by food, milk, or infant formula.29
Topical treatment is clearly an attractive option for
patients with impetigo. It has the advantage of being easily
applied only where needed, which minimizes systemic
side effects, as well as promptness of response was often
dramatic. In this study, the topical therapy consisted of the
use of antiseptic soap and mixed cream.
Since good general health and hygiene help to prevent
infection. Therefore, antiseptic soap was a useful adjunct
to antibiotic treatment, to soften crusts and clear exudates.
The combined cream was composed of 15g fusidic acid
cream with 5g hydrocortisone 1%. Fusidic acid is used for
mild to moderately severe skin and soft-tissue infections,
including impetigo. When topical and oral routes of
treatment have been studied individually and compared,
the oral route has had a higher level of effectiveness and
lower rate of recurrence.30 However, fusidic acid cream
accelerates clinical improvement in impetigo.
Nasal carriage of S. aureus may predispose an individual to
recurrent infection A possible cause for this is that the
bacteria can live in ('colonise') the nose. They do no harm
there but sometimes spread out and multiply on the face
to cause impetigo. Fusidic acid can be used to eliminate
nasal carriage of in the context of preventing recurring
infections.31 For this reason, the patients were instructed
to apply the combined cream into each nostril at night
time.
Impetigo lesions are itchy and slightly painful which leads
to scratching, hydrocortisone can help to decrease the
inflammation, so that, can relief the symptoms of itching
and swelling.32 For this reason, no patient experienced
itching while applied the combined cream. The cure rate
after 8 days of the treatment with both topical and
systemic antibiotic was 100% with no recurrence.
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CONCLUSION
In conclusion, a short-course treatments with single-dose
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medications and for families who might have compliance
problems. Fusidic acid-steroid combination products are
particularly useful for treating both infection and
inflammation in treatment of impetigo. Parents were
universally pleased with the outcome and ease of using the
topical mixed cream as well as it was well-tolerated. We
recommend that a dual therapy of both systemic and
topical antibiotic is a good choice for rapid and effective
treatment of impetigo with very few side effects.
ACKNOWLEDGEMENT
I gratefully acknowledge the support of the at Al-qudis
health center for family medicine. Grateful thanks for Dr
Mohammad Attarbashi for his assistance and support
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