Once-Daily Therapy for Streptococcal Pharyngitis With Amoxicillin

Henry M. Feder Jr, Michael A. Gerber, Martin F. Randolph, Paulette S. Stelmach and
Edward L. Kaplan
Pediatrics 1999;103;47-51
DOI: 10.1542/peds.103.1.47

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://www.pediatrics.org/cgi/content/full/103/1/47

PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and
trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove
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reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

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 Once-Daily Therapy for Streptococcal Pharyngitis With Amoxicillin
Henry M. Feder, Jr, MD*; Michael A. Gerber, MD‡; Martin F. Randolph, MD§;
Paulette S. Stelmach, MT(ASCP), MS\; and Edward L. Kaplan, MD¶
ABSTRACT. Objective. An orally administered anti-
microbial regimen for the treatment of group A b-hemo-
lytic streptococcal (GABHS) pharyngitis given once
rather than multiple times each day would be more con-
venient and might result in improved patient compli-
ance. The purpose of this study was to evaluate the
effectiveness of once-daily amoxicillin in the treatment
of GABHS pharyngitis.
Patients. Children presenting to a private pediatric
office with GABHS pharyngitis.
Design. Patients were randomly assigned to receive
orally either amoxicillin (750 mg once daily) or penicillin
V (250 mg three times a day) for 10 days. Compliance was
monitored by urine antimicrobial activity.
Outcomes. Outcomes were measured by impact on
the clinical course, eradication of GABHS within 18 to 24
hours, and bacteriologic treatment failure rate as deter-
mined by follow-up throat cultures 4 to 6 and 14 to 21
days after completing therapy. GABHS isolates were se-
rotyped to distinguish bacteriologic treatment failures
(same serotype as initial throat culture) from new acqui-
sitions (different serotypes).
Results. During the 16 months of this study, 152 chil-
dren between 4 and 18 years of age (mean, 9.9 years) were
enrolled; 79 children were randomly assigned to receive
once-daily amoxicillin and 73 were assigned to receive
penicillin V three times a day. The children in the two
treatment groups were comparable with respect to age,
duration of illness before initiation of therapy, compli-
ance, and signs and symptoms at presentation. There was
no significant difference in the clinical or bacteriologic
responses of the patients in the two treatment groups at
the 18- to 24-hour follow-up visit. Bacteriologic treatment
failures occurred in 4 (5%) of the 79 patients in the
amoxicillin group and in 8 (11%) of the 73 patients in the
penicillin V group.
Conclusions. These data demonstrate that once-daily
amoxicillin therapy is as effective as penicillin V therapy
given three times a day for the treatment of GABHS
pharyngitis, and if confirmed by additional investiga-
tions, once-daily amoxicillin therapy could become an
alternative regimen for the treatment of this disease.
Pediatrics 1999;103:47–51; group A streptococcal, pharyn-
From the *Department of Family Medicine and Pediatrics, University of
Connecticut School of Medicine, University of Connecticut Health Center,
Farmington, Connecticut; the ‡Department of Pediatrics, University of Con-
necticut School of Medicine, Connecticut Children’s Medical Center, Hart-
ford, Connecticut; §Private Practice, Danbury, Connecticut; the \Depart-
ment of Laboratory Medicine, University of Connecticut Health Center,
Farmington, Connecticut; and the ¶Department of Pediatrics, University of
Minnesota School of Medicine, Minneapolis, Minnesota.
Received for publication Mar 20, 1998; accepted Jun 18, 1998.
Reprint requests to (H.M.F.) Department of Family Medicine, University of
Connecticut Health Center, Farmington, CT 06030-3960.
PEDIATRICS (ISSN 0031 4005). Copyright © 1999 by the American Acad-
emy of Pediatrics.
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gitis, treatment, amoxicillin, Streptococcus pyogenes,
streptococcal infections.
ABBREVIATION. GABHS, group A b-hemolytic streptococcus.
A
n orally administered antimicrobial regimen
for the treatment of group A b-hemolytic
streptococcal (GABHS) pharyngitis that could
be given once rather than several times each day
would be convenient, especially for children who are
attending school. A single daily dose might also
result in improved patient compliance. Four antimi-
crobials are currently approved by the United States
Food and Drug Administration for once-daily ther-
apy for GABHS pharyngitis: cefadroxil, cefixime, cef-
tibuten, and azithromycin.1–5 Unfortunately, these
agents all have a broad spectrum of antimicrobial
activity and are relatively expensive. Penicillin is the
treatment of choice for GABHS pharyngitis; how-
ever, in two earlier studies, orally administered pen-
icillin G and penicillin V given once daily were both
ineffective in the treatment of this disease.6,7 Pharma-
cokinetic data and clinical experience suggested that
orally administered amoxicillin given once daily
might be effective in the treatment of GABHS phar-
yngitis,8 –14 as did a recent investigation by Shvartz-
man and co-workers.15 Therefore, we initiated a pro-
spective, randomized, controlled investigation to
compare two treatment regimens for GABHS phar-
yngitis: 750 mg of amoxicillin given orally once daily
and the conventional regimen of 250 mg of penicillin
V given orally three times daily. Outcomes were
measured by the eradication of GABHS from the
upper respiratory tract 18 to 24 hours after beginning
therapy, the impact on the clinical course, and the
bacteriologic treatment failure rate.1
PATIENTS AND METHODS
During the winter to spring of 1996 to 1997, consecutive pa-
tients between 3 and 18 years of age seen in a private pediatric
office in Danbury, Connecticut (M.F.R.) with clinical findings sug-
gestive of GABHS pharyngitis were enrolled in the investigation
after written, informed consent had been obtained. Patients with a
history of hypersensitivity to penicillin or amoxicillin and patients
who had received antimicrobial therapy within the previous week
were excluded.
All study patients were evaluated as previously described for
the presence of three objective signs (fever; tonsillar exudate; and
tender, enlarged cervical lymph nodes) and one subjective symp-
tom (sore throat) before and 18 to 24 hours after the initiation of
antimicrobial therapy.16 Two rayon-tipped swabs (Culturette II;
Marion Scientific, Kansas City, MO) were then simultaneously
and vigorously rubbed over each patient’s posterior pharynx and
tonsils (or tonsillar fossae). One swab was used to perform a rapid
PEDIATRICS Vol. 103 No. 1 January 1999 47
antigen detection test for GABHS (Q-test; Becton Dickinson, Cock-
eysville, MD) and the other swab was transported by overnight
courier to the Clinical Microbiology Laboratory at the University
of Connecticut Health Center where it was streaked onto a blood
agar plate, incubated anaerobically overnight at 37°C, and then
examined for the presence of b-hemolytic streptococci. All b-
hemolytic streptococci were confirmed as group A with the Strep-
tex test (Murex Biotech Ltd, Kent, England).
At the initial visit, patients were randomly assigned (using a
table of random numbers) to receive either 250 mg of penicillin V
(250 mg/5 mL of suspension) orally three times daily for 10 days
or 750 mg of amoxicillin (250 mg/5 mL of suspension) orally once
a day for 10 days. All patients were asked to return in 18 to 24
hours for a follow-up visit at which time they were reevaluated by
the same physician who had performed the initial assessment and
who was unaware of which treatment regimen had been received.
At this follow-up visit, a second throat culture was obtained.
Patients returned for additional follow-up visits 4 to 6 and 14 to 21
days after completing the assigned antimicrobial therapy, or if any
signs or symptoms suggestive of GABHS pharyngitis recurred. At
each of these follow-up visits a repeat throat culture was obtained.
All follow-up throat cultures were processed in the same labora-
tory at the University of Connecticut Health Center as the initial
culture. Any patient who had received the experimental amoxi-
cillin regimen and had a positive throat culture at the 18- to
24-hour, the 4- to 6-day, or the 14- to 21-day follow-up visit was
given a 10-day course of penicillin V administered three times
daily (conventional therapy). In addition, patients who had re-
ceived the conventional penicillin regimen and had signs or symp-
toms of pharyngitis with a positive throat culture at the 4- to 6-day
or the 14- to 21-day follow-up visit were given another 10-day
course of the penicillin V regimen.
For patients with positive follow-up throat cultures, pretreat-
ment and posttreatment GABHS isolates were characterized by M
typing and T agglutination patterns and by serum opacity reac-
tions according to established methods.17 Bacteriologic treatment
failures were defined as the presence of the same serotype of
GABHS on either follow-up culture (4 to 6 days or 14 to 21 days
after completing therapy) as on the initial throat culture, regard-
less of the clinical status of the patient. Patients with a different
serotype of GABHS on the follow-up than on the initial throat
culture were considered to have newly acquired GABHS rather
than a treatment failure.
Compliance was determined by having a parent dip a strip of
filter paper into the patient’s urine on the seventh day of antimi-
crobial therapy. The strip was allowed to air-dry and was then
mailed in a preaddressed envelope to the University of Connect-
icut Health Center where it was assayed for antimicrobial activity
using a modification of the technique of Markowitz and Gordis.18
Data were analyzed using Student’s t test and x2 analysis.
Fig 1. Specific signs and symptoms before and after 18 to 24 hours of therapy.
48 ONCE-DAILY AMOXICILLIN FOR STREPTOCOCCAL PHARYNGITIS
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RESULTS
GABHS were isolated from 161 patients who were
randomly assigned to treatment groups as follows:
84 received 750 mg of amoxicillin once daily and 77
received 250 mg of penicillin V three times daily for
10 days. Six patients (2 in the amoxicillin group and
4 in the penicillin V group) were not included in the
analyses because they had failed to return for their
follow-up visits and 3 patients (all in the amoxicillin
group) because they had prematurely discontinued
their therapy. One patient discontinued the amoxi-
cillin prematurely because of urticaria, 1 because of
abdominal pain, and 1 because he was switched to
erythromycin therapy after being diagnosed with
Mycoplasma pneumoniae pneumonia. The remaining
152 patients (79 amoxicillin and 73 penicillin V)
ranged in age from 4 to 18 years (mean age, 9.9
years). The patients in the amoxicillin and penicillin
V treatment groups were similar with respect to age
(mean, 9.0 years and 11.4 years, respectively), sex
(65% and 62% males, respectively), duration of ill-
ness before treatment (mean, 1.2 days and 1.4 days,
respectively), and clinical findings at the time of the
initial visit (Fig 1). Approximately 85% of the pa-
tients in both treatment groups returned their filter
paper strips and ;80% of these patients in both
treatment groups were determined to be compliant.
All 152 patients returned for the 18- to 24-hour
follow-up evaluation. At this time the clinical re-
sponses of the patients in the two treatment groups
were comparable—;90% of patients in both treat-
ment groups were afebrile and clinically improved
(Fig 1). At this time, 1 (1%) of the 73 patients in the
penicillin V group and none of the 79 patients in the
amoxicillin group had a positive throat culture for
GABHS.
All 152 patients returned for follow-up visits 4 to 6
days and/or 14 to 21 days after completing therapy.
Overall, 28 (18%) of the 152 patients had GABHS
isolated on the follow-up throat culture obtained at
TABLE 1. Bacteriologic Response to Antibiotic Therapy
Patients No. of Positive Throat
Cultures After Completion
of Therapy*
4–6 Days
n (%)
Amoxicillin 79 9 (11)
(once-daily)
Penicillin V 73 12 (16)
(three times daily)
* Only first positive culture, repeat positives not included.
† Same serotype as initial isolate.
‡ Different serotype from initial isolate.
§ Symptomatic.
one of these visits as shown in Table 1. Of the 79
patients in the once-daily amoxicillin group, 13 (16%)
had GABHS isolated on one of these follow-up throat
cultures: 4 (5%) had strains identical to the strains
isolated on their initial throat cultures and were con-
sidered to have bacteriologic treatment failures,
whereas 9 (11%) had different strains of GABHS and
were considered to have new acquisitions. Of the 4
patients with bacteriologic treatment failures, 1 had
signs or symptoms suggestive of GABHS pharyngitis
at the time of their positive follow-up throat culture.
Of the 73 patients in the three times daily penicillin V
group, 15 (21%) had GABHS isolated on one of these
follow-up throat cultures: 8 (11%) had strains iden-
tical to the strains isolated on their initial throat
cultures and were considered to have bacteriologic
treatment failures, whereas 7 (10%) had different
strains of GABHS and were considered to have new
acquisitions. Of the 8 patients with bacteriologic
treatment failures, 1 had signs or symptoms sugges-
tive of GABHS pharyngitis at the time of their posi-
tive follow-up throat culture. There was no signifi-
cant difference between the amoxicillin and
penicillin V treatment groups in the number of pa-
tients with positive follow-up throat cultures or in
the number of patients with bacteriologic treatment
failures. The number of patients with symptomatic
treatment failures was too small to analyze statisti-
cally. There was no relationship between either the
ages of the patients or compliance and the bacterio-
logic outcomes. All the patients with treatment fail-
ures who received a subsequent 10-day course of
penicillin V remained well during the several
months follow-up observation and repeat cultures
were not performed or treatment given again during
this period.
Both the amoxicillin and penicillin therapies were
well tolerated. Among the 79 patients who com-
pleted the amoxicillin therapy, 2 patients developed
macular rashes, 3 patients developed diarrhea, and 3
patients complained of abdominal pain. Among the
73 patients who completed the penicillin therapy, 1
patient developed urticaria after his last dose, 2 pa-
tients developed diarrhea, and 1 patient developed
abdominal pain. The side effects from either penicil-
lin or amoxicillin resolved within 24 hours of stop-
ping the antibiotics.
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Cumulative Number of Positive Follow-up
Throat Cultures
14–21 Days Treatment New Total
n (%) Failures† Acquisitions‡ n (%)
n (%) n (%)
4 (5) 4 (5) 9 (11) 13 (16)
1§
3 (4) 8 (11) 7 (10) 15 (21)
1§
DISCUSSION
Amoxicillin given three times daily for 10 days has
been shown to be just as effective as penicillin V
given three times daily for 10 days in the treatment of
GABHS pharyngitis.13,14 A single high-dose of amoxi-
cillin with probenicid has been used to treat gono-
coccal urethritis.10,11 Clinical data suggest that orally
administered amoxicillin might be effective in the
treatment of GABHS when given as a single daily
dose of 750 mg.15 The absorption of amoxicillin is
unaffected by the ingestion of food8,9 and its serum
half-life in children is 1.1 to 1.8 hours.8 In contrast,
the absorptions of both penicillin G and penicillin V
are reduced by the ingestion of food and these agents
have serum half-lives in children of 0.95 to 1.2 hours
and 0.76 to 0.99 hours, respectively.19 In addition, the
peak serum levels in children after a 125-mg orally
administered dose of penicillin V and amoxicillin are
1.74 mg/mL and 3.86 mg/mL, respectively. The min-
imal inhibitory concentrations of penicillin V and
amoxicillin for GABHS are comparable.9,13,20
In the present study, we have demonstrated that
750 mg of amoxicillin suspension given once-daily
for 10 days is as effective as 250 mg of penicillin V
suspension given three times daily for 10 days. These
two antimicrobial regimens were comparable in their
abilities to eradicate GABHS from the upper respira-
tory tract, in their impacts on the clinical course of
the disease, and in their bacteriologic treatment fail-
ure rates. The clinical responses, eradication rates at
18 to 24 hours, and the bacteriologic treatment failure
rates for the patients in both treatment groups in this
study were comparable to those reported in earlier
investigations.2,7,16 The compliance rates for the pa-
tients in our study who received once-daily amoxi-
cillin and three times daily penicillin V were compa-
rable. It has been shown, however, that the fewer
doses per day a patient is requested to take, the
better their compliance.21
The power of this study to demonstrate a statisti-
cally significant difference in the effectiveness of the
two antimicrobial regimens is limited by the sample
size. For example, the b error in the comparison of
bacteriologic treatment failure rates for once-daily
amoxicillin and three-times-daily penicillin V is
.0.70. To be able to show a statistically significant
difference between a 5% and 11% bacteriologic treat-
ARTICLES 49
ment failure rate with a two-tailed a of 0.05, one
would need to enroll 353 participants in each of the
treatment groups.
One potential problem with using amoxicillin to
treat suspected GABHS pharyngitis is if the patient
has infectious mononucleosis, the amoxicillin may
produce a morbilliform rash that could be misinter-
preted as an allergic reaction. This did not occur in
our study; however, if it does occur, the rash is
self-limited and resolves when the amoxicillin is dis-
continued.22 The risk of this rash occurring can be
reduced by administering amoxicillin only to those
patients who have either a positive rapid antigen
detection test or throat culture. In addition, infec-
tious mononucleosis can be suspected (and amoxicil-
lin avoided) if splenomegaly is present.
Previous attempts have been made to treat
GABHS pharyngitis with a single daily dose of orally
administered penicillin. Breese et al6 gave 50 children
a single dose of 800 000 units buffered penicillin G
each day for 10 days and compared the outcomes of
these patients with those of patients who received
standard therapy. Serotyping of isolates was not per-
formed, and, therefore, bacteriologic treatment fail-
ures could not be distinguished from new acquisi-
tions. They found that 42% of patients had positive
follow-up throat cultures during the 2 months after
completion of once-daily penicillin therapy. In con-
trast, 14% to 15% of the children with GABHS phar-
yngitis who had been given the same total daily dose
of penicillin G in either two or four divided doses
had positive follow-up throat cultures. The authors
concluded that a single dose of 800 000 units buff-
ered penicillin G orally each day for 10 days was
inadequate for the treatment of GABHS pharyngitis.
In 1989, we reported that a single daily dose of
penicillin V (750 mg) for 10 days was comparable to
250 mg of penicillin V three times daily for 10 days in
its ability to eradicate GABHS from the upper respi-
ratory tract in 18 to 24 hours and in its impact on the
clinical course of the disease. However, a bacterio-
logic treatment failure occurred in 6 (8%) of the 76
patients in the three-times-daily group and in 16
(22%) of the 74 patients in the once-daily group (P ,
.05).7 In a preliminary investigation in which patients
received 1500 mg of penicillin V once-daily for 10
days, we observed a 20% bacteriologic treatment fail-
ure rate, suggesting that a doubling of the single
daily dose of penicillin V would not have been effec-
tive.7
In the only previous investigation of once-daily
amoxicillin in the treatment of GABHS pharyngitis,
Shvartzman et al15 compared a group of 82 patients
who received 250 mg of penicillin V given three or
four times daily for 10 days with a group of 75
patients who received a once-daily dose of amoxicil-
lin (50 mg/kg for children not to exceed the adult
dose and 750 mg for adults) for 10 days. There was
no difference observed in the clinical responses of the
patients in the two treatment groups or in the pro-
portion of patients in the two treatment groups with
positive throat cultures 24 to 48 hours after initiating
antimicrobial therapy. However, the patients receiv-
ing once-daily amoxicillin had significantly fewer
50 ONCE-DAILY AMOXICILLIN FOR STREPTOCOCCAL PHARYNGITIS
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bacteriologic treatment failures 4 to 11 days after
completing antimicrobial therapy than the patients
receiving three-times-daily penicillin (0% and 6.1%,
respectively; P , .05).
Recently, investigators have demonstrated that
once-daily azithromycin as well as once-daily reg-
imens of several cephalosporins (eg, cefadroxil,
cefixime, ceftibuten, cefpodoxime, cefprozil) are
comparable with penicillin V administered three to
four times daily in the treatment of GABHS phar-
yngitis1–5,23,24. However, the cost of these agents,
even as a single daily dose, as well as their broader
spectra of antimicrobial activity, have precluded
their widespread adoption as standard therapy for
GABHS pharyngitis.
The results of this and one earlier investigation
demonstrate that once-daily amoxicillin therapy is
effective in the treatment of GABHS pharyngitis.
Once-daily amoxicillin therapy is well-tolerated by
patients and convenient for parents. Amoxicillin is
less expensive and has a narrower spectrum of anti-
microbial activity than the presently approved once-
daily antimicrobial regimens for the treatment of
GABHS pharyngitis. If confirmed by additional in-
vestigations, once-daily amoxicillin therapy could
become an alternative regimen for the treatment of
GABHS pharyngitis.
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Submitted by Student
ARTICLES 51
 Once-Daily Therapy for Streptococcal Pharyngitis With Amoxicillin
Henry M. Feder Jr, Michael A. Gerber, Martin F. Randolph, Paulette S. Stelmach and
Edward L. Kaplan
Pediatrics 1999;103;47-51
DOI: 10.1542/peds.103.1.47
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