ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Aug. 1992, p. 1614-1618 Vol. 36, No.

8
0066-4804/92/081614-05$02.00/0
Copyright © 1992, American Society for Microbiology

Evaluation of Cefuroxime Axetil and Cefadroxil Suspensions

for Treatment of Pediatric Skin Infections
RICHARD F. JACOBS,`* WALLACE D. BROWN,2 STEPHEN CHARTRAND,3 PAUL DARDEN,4
MARGARET A. DREHOBL,S ROBERT YETMAN,6 AND MICHAEL J. OSSI7
Arkansas Children's Hospital, Little Rock, Arkansas 722021; Raleigh Pediatric Association, Raleigh,
North Carolina 276092; Creighton University School of Medicine, Omaha, Nebraska 681783;
Medical University of South Carolina, Charleston, South Carolina 294254; Scripps
Clinic-Rancho Bernardo, San Diego, California 921015; University of Te-xas
Medical School, Houston, Texas 770256; and Glaxo Inc.,
Research Triangle Park, North Carolina 277097
Received 7 October 1991/Accepted 15 May 1992

A randomized, single-blind, multicenter study was conducted to evaluate the safety and efficacy of
cefuroxime axetil and cefadroxil suspensions for the treatment of skin or skin structure infections in 287
children. Each drug was given at a dosage of 30 mg/kg of body weight per day in two divided doses.
Staphylococcus aureus and Streptococcus pyogenes, or a combination of the two, were the primary pathogens
isolated from infected skin lesions. A satisfactory bacteriological response (cure or presumed cure) was
obtained in 97.1 and 94.3% of children in the cefuroxime axetil and cefadroxil groups, respectively (P > 0.05).
Satisfactory clinical responses (cure or improvement) were more likely to occur in cefuroxime axetil recipients
than in cefadroxil recipients (97.8 versus 90.3%; P < 0.05). Both regimens were equally well tolerated, with
adverse events occurring in 7.9 and 6.1% of cefuroxime axetil and cefadroxil recipients, respectively. There
were more patients who refused to take cefuroxime axetil (7 of 189) than there were who refused to take
cefadroxil (0 of 98), but the difference was not statistically significant (P = 0.1). In this study, cefuroxime axetil
was at least as effective as cefadroxil in resolving skin and skin structure infections in children.

Cefuroxime is an expanded-spectrum cephalosporin with MATERIALS AND METHODS

improved P-lactamase stability and a broad spectrum of
activity against clinically important gram-positive and gram- Eligibility criteria. Children (ages 3 months to 12 years)
with skin or skin structure infections requiring antibiotic
negative pathogens. The lowest concentrations that inhibited treatment were eligible to participate in the study. Patients
the growth of 90% of the Staphylococcus aureus and Strep- were excluded if any of the following were present: infection
tococcus pyogenes strains tested are 1 to 2 and <0.125 requiring incision and drainage, hypersensitivity to cephalo-
,ug/ml, respectively (2). sporin or penicillin, previous systemic antibacterial drug
Cefuroxime axetil, the acetyloxyethyl ester of cefuroxime, treatment (within 7 days), history of gastrointestinal disorder
is a prodrug that is suitable for oral administration. After oral that could alter drug absorption (within 3 months), unstable
ingestion, cefuroxime axetil is deesterified in the intestinal concomitant disease, immunosuppression, or previous en-
mucosa and appears as cefuroxime in the blood. Peak rollment in this study. Patients were to be withdrawn after
concentrations in serum increase in proportion to dose and enrollment if, upon culture and susceptibility testing, no
are 3.3 and 5.1 ,ug/ml after oral doses of a cefuroxime axetil pathogen was isolated or the pathogen was not susceptible to
suspension of 10 and 15 mg/kg of body weight, respectively the study drugs (e.g., methicillin-resistant S. aureus). Pa-
(12). These results are comparable to those achieved in tients were discontinued from the study if any of the follow-
adults following administration of a 250-mg cefuroxime ing occurred: adverse event necessitating discontinuation of
axetil tablet (7). Thus, achievable concentrations in serum drug therapy, treatment failure or recurrence of infection,
exceed the MICs for common cutaneous pathogens (2). The patient refusal of further doses, or failure to return for
tablet formulation of cefuroxime axetil has previously been follow-up.
found to be effective in the treatment of skin or skin Study design. This was an evaluator-blinded, multicenter
structure infections in adults (4, 5). study. Patients were randomly chosen to receive either
The purpose of the study described here was to evaluate cefuroxime axetil suspension (Ceftin; Glaxo Inc., Research
the efficacy and safety of a new liquid suspension of cefur- Triangle Park, N.C.) or cefadroxil suspension (Duricef;
Mead Johnson Pharmaceuticals, Evansville, Ind.) in a 2:1
oxime axetil in children with skin or skin structure infec- ratio according to a predetermined randomization schedule.
tions. Cefadroxil suspension was selected as the active Both drugs were administered orally at a dosage of 30
control because it has been proven to be effective in the mg/kg/day in two divided doses every 12 h (maximum dose,
treatment of skin or skin structure infections and is suitable 1 g/day) for 10 days. Cefuroxime axetil was given after
for twice-daily administration. morning and evening meals, because postprandial adminis-
tration of cefuroxime axetil (in the tablet form) has been
shown to enhance absorption (3). Cefadroxil was given
without regard to mealtimes, as recommended by the man-
ufacturer. Compliance was assessed by assay of antibiotic
*
Corresponding author. activity in urine during treatment and by the volume of drug
1614
VOL. 36, 1992 CEFUROXIME AXETIL AND CEFADROXIL SUSPENSION EVALUATION 1615

returned upon completion of the treatment period. The TABLE 1. Patient enrollment and demographic dataa
absence of detectable antibacterial activity in a during- Cefuroxime
treatment urine sample excluded a patient from the efficacy Parameter Cefadroxil P
axetil value
analyses. Written informed consent was obtained from all
patients' parents or legal guardians. This protocol was Enrollment data
approved by the institutional review boards of the respective Total enrolled (no.) 189 98
investigators' institutions. Population for analysis 156 (82.5) 82 (83.7)
Efficacy assessment. Response to treatment was assessed (no. [%])
bacteriologically and clinically. Although 10 days is the Age (mo)b 69.6 + 3.3 65.6 ± 4.8 NSc
standard length of therapy for most infections in children, for
purposes of efficacy assessments, 5 days (10 doses) was Wt (kg)b 25.2 ± 1.0 24.8 ± 1.6 NS
predetermined as the minimum length of treatment neces-
sary to effect clinical improvement and eradication of the No. (%) of females 72 (46.2) 39 (47.6) NS
causative organism(s) from superficial skin infections.
Specimens from the involved skin lesion(s) were obtained Ethnic origin (no. [%])
for bacterial culture and susceptibility testing at the initial Caucasian 71 (45.5) 48 (58.5) 0.007
visit and, if culturable material was present, at the during- Black 74 (47.4) 26 (31.7)
Hispanic 9 (5.8) 7 (8.5)
and posttreatment visits. Material for culture was obtained Other 2 (1.3) 1 (1.2)
by needle aspiration or sterile swab of a lesion(s). Crusted
material was partially unroofed. The culture material ob- Diagnosisd
tained was processed at an accredited laboratory according Impetigo 126 (80.8) 66 (80.5) NS
to that laboratory's standard protocol for wound or surface Cellulitis 14 (9.0) 8 (9.8)
specimen culture. Standard disk or dilution methods were Injury-induced wound 13 (8.3) 6 (7.3)
used for susceptibility testing; the current criteria of the Paronychia 10 (6.4) 4 (4.9)
National Committee for Clinical Laboratory Standards were Other' 7 (4.5) 5 (6.1)
used to interpret the results (10). Bacteriological outcome Therapy
was determined at the completion of the study or when the Mean dose (mg/kg/day)b 28.6 ± 0.4 28.4 ± 0.4 NS
patient's condition dictated the need for alternate antibiotic Mean duration (days) 10.3 ± 0.2 10.5 ± 0.2 NS
therapy. Bacterial responses were rated as cure (initial
pathogen eradicated), failure (identification of the original a Demographic data of the population used for analysis.
b
Data are means ± standard errors.
pathogen in a follow-up culture), or relapse (eradication with c NS, not significant.
subsequent isolation of the original pathogen). Presumptive d There was more than one primary diagnosis for some patients.
bacterial responses were made on the basis of the clinical Other diagnoses were furunculosis (for the cefuroxime axetil and ce-
response when follow-up cultures were not obtainable be- fadroxil treatment groups, 2 and 0 patients, respectively), pyoderma (1 and 3
cause of healing of the lesion(s) (e.g., presumed cure). For
patients, respectively), carbunculosis (1 and 0 patients, respectively), buttock
abscess (1 and 0 patients, respectively), folliculitis (1 and 0 patients, respec-
statistical analysis, bacteriological outcomes were grouped tively), skin infection began as contact dermatitis (1 and 0 patients, respec-
as satisfactory (cure or presumed cure) or unsatisfactory tively), lymphangitis (0 and 1 patient, respectively), and nonspecific skin rash
(failure or relapse). with exudates (0 and 1 patient, respectively).
Patients underwent at least three clinical evaluations at the
following intervals: at the start of therapy (initial visit), at 4
to 6 days after the initiation of therapy (during treatment), collected for complete blood count with differential, platelet
and at 5 to 7 days after the completion of therapy (posttreat- count, prothrombin time, and the direct Coomb's test and
ment). If complete healing did not occur at 5 to 7 days, an for evaluation of hepatic enzymes, blood urea nitrogen, and
additional visit was required at 14 to 20 days posttreatment. serum creatinine. Urine was obtained for evaluation of
Clinical response was rated as cure (resolution of clinical albumin and glucose and a microscopic examination. These
signs and symptoms of infection), improvement (resolution tests were performed at the initial and posttreatment visits.
of signs and symptoms with incomplete lesion healing; Statistical analysis. Two-sided statistical tests were used.
further antibacterial therapy required), failure (no improve- Demographic data were summarized by using a van Elteren
ment after 25 days of treatment or discontinuation of statistic (13) (patient age and weight), a Mantel-Haenszel
treatment because of adverse event; alternate antibacterial statistic (9) controlling for investigational center (sex and
therapy required), or recurrence (initial diminution of signs ethnic origin), or a Fisher exact test (8) (allergy, significant
and symptoms but recurrence by the posttreatment visit; medical history, and abnormal physical finding) to examine
further or alternate antibacterial therapy required). For the comparabilities of treatment groups. Summary statistics
statistical analysis, a satisfactory clinical response was de- were performed on bacteriological and clinical assessments;
fined as cure or improvement; an unsatisfactory clinical the Mantel-Haenszel test was used to evaluate differences
response was defined as failure or recurrence. between treatment groups. The incidence rates of adverse
Safety assessment. All patients were monitored for adverse events were compared between treatment groups by using a
events. Each patient's parent or guardian was interviewed at Fisher exact test. A P value of 0.05 or less was considered
each visit to determine the presence of adverse events. In statistically significant.
order to avoid bias in eliciting adverse events, the initial
questioning was restricted to "Is your child having any RESULTS
problems?" In addition, physical findings that were detected
by the physician observer but that were not present at the A total of 287 patients from 11 centers were enrolled in the
initial visit were recorded as adverse events and were study (Table 1). Forty-nine patients were excluded from the
assessed as to their possible relationship to treatment. For analyses because of the following prespecified protocol
the purpose of monitoring laboratory safety, blood was violations: inability to isolate a pathogen from the pretreat-
1616 JACOBS ET AL. ANTimICROB. AGENTS CHEMOTHER.

ment culture (for the cefuroxime axetil and cefadroxil treat- TABLE 2. Bacteriological outcome
ment groups, 17 and 10 patients, respectively), negative
urine bioassay (8 and 1 patient, respectively), absence of No. (%) of patientsa
susceptibility testing on pretreatment pathogen (6 and 4 Result Cefuroxime
patients, respectively), resistant pathogen (2 and 0 patients, axetil Cefadrox
respectively), and concurrent antimicrobial therapy (0 and 1 Satisfactory 134 (97.1) 66 (94.3)b
patient, respectively). The two resistant pathogens were Cure 27 (19.6) 12 (17.1)
methicillin-resistant S. aureus. One cefuroxime axetil- Presumed cure 107 (77.5) 54 (77.1)
treated patient from whom no pathogen was isolated in the
pretreatment culture was withdrawn from the study because Unsatisfactory 4 (2.9) 4 (5.7)
of the patient's refusal to take the study medication. Two Failure 3 (2.2) 4 (5.7)
additional patients who were withdrawn from the study Relapse 1 (0.7) 0
because of refusal to take the study medication were ex-
cluded from the analysis because of prior negative urine Subtotal (bacteriologically 138 70
bioassays. The remaining six patients with negative urine evaluable)
bioassays were either lost to follow-up (n = 3) or completed
the study but did not return medication bottles to provide Unevaluable
other evidence of compliance (n = 3). The cefadroxil-treated Lost to follow-up 11 9
patient completed the study but did not return medication Received drug for <5 days 7 2
bottles to provide other evidence of compliance. In total, Clinical recurrence without 0 1
three cefuroxime axetil-treated patients who refused to take documented bacteriologi-
the study medication were excluded from analysis because cal outcome
of the prespecified protocol violations described above; data
for these patients are not given below in the bacteriological Total 156 82
and clinical outcome sections. All patients with protocol
violations were included in an intent-to-treat analysis, the a Percentage of bacteriologically evaluable patients.
b p = 0.242, by comparing satisfactory versus unsatisfactory responses.
results of which appear later in this report. There were no
differences (P > 0.05) between the two treatment groups in
the proportion of patients with any particular reason for
exclusion from analysis. and cefadroxil recipients, respectively (P = 0.242). In the
After excluding the 49 patients, 156 patients in the cefur- cefuroxime axetil group, all unsatisfactory responses were
oxime axetil treatment group and 82 patients in the ce- associated with infections caused by S. aureus (three fail-
fadroxil treatment group were available for bacteriological ures, one relapse). Likewise, unsatisfactory responses in the
and clinical efficacy analyses. These remaining patients were cefadroxil group were associated with infections caused by
evenly distributed on the basis of age, weight, and sex but S. aureus (four treatment failures). Two of these patients had
not ethnic origin. The majority of cefadroxil recipients were polymicrobial infections that were also caused by S. pyo-
Caucasian, whereas cefuroxime axetil recipients were nearly genes or non-group A, ,3-hemolytic streptococci.
evenly divided between Caucasian and black ethnic origins When all patients were included in an intent-to-treat
(P < 0.007). The primary diagnosis in both groups was analysis (i.e., patients previously excluded because of pre-
impetigo; this was followed in descending order of frequency specified protocol violations and patients classified as bac-
by cellulitis, injury-induced wound infection, and parony- teriologically unevaluable), a satisfactory response was de-
chia. The mean dose received (approximately 28 mg/kg/day) fined as cure or improvement, and an unsatisfactory
and the duration of treatment (10 days) were nearly identical response was all other responses (including unevaluable). In
for the two treatment groups. these evaluable patients, satisfactory responses occurred in
Bacteriological outcome. In the cefuroxime axetil-treated 70.9 and 68.4% of cefuroxime axetil and cefadroxil recipi-
patients, 198 of 206 pathogens isolated were either S. aureus ents, respectively (P = 0.625) (Table 3).
(n = 129; 63%) or S. pyogenes (n = 69; 33%). Both S. aureus Clinical outcome. Twenty-eight patients were clinically
and S. pyogenes were isolated as copathogens from 47 of 156 unevaluable because of failure to return for follow-up, drug
patients in this group. In the cefadroxil group, 104 of 110 treatment for less than 5 days (less than 10 doses), or
pathogens were S. aureus (71; 65%) or S. pyogenes (33; withdrawal from the study for reasons other than an adverse
30%). Both microorganisms were isolated from 23 of 82 event (Table 4). Six cefuroxime axetil recipients were clas-
patients in this group. sified by the investigator as receiving drug for less than 5
Thirty patients were bacteriologically unevaluable be- days. These patients were described above in the bacterio-
cause of failure to return for follow-up, drug treatment for
less than 5 days (less than 10 doses), or clinical recurrence
without a documented bacteriological outcome (Table 2). Of TABLE 3. Bacteriological outcome (intent to treat)
the seven cefuroxime axetil-treated patients classified by the No. (%) of patients
investigator as receiving less than 5 days of study drug, four Resulta
withdrew from the study because of refusal to take the study Cefuroxime axetil Cefadroxil
medication, one withdrew before any doses were given, and Satisfactory 134 (70.9) 67 (68.4)b
two withdrew because of an inability to complete the study Unsatisfactory 55 (29.1) 31 (31.6)
requirements for personal reasons. Of the cefadroxil-treated
patients who received less than 5 days of study drug, one All patients 189 98
withdrew for personal reasons and one withdrew because of a Satisfactory was defined as cure, presumed cure, or cure with infection.
an adverse event. Of the remaining patients, satisfactory
Unsatisfactory was defined as all other responses (including unevaluable).
responses occurred in 97.1 and 94.3% of cefuroxime axetil b p = 0.625, by comparing satisfactory versus
unsatisfactory responses.
VOL. 36, 1992 CEFUROXIME AXETIL AND CEFADROXIL SUSPENSION EVALUATION 1617

TABLE 4. Clinical outcome TABLE 6. Adverse events almost certainly, probably,

or possibly related to drug therapy
No. (%) of patientsa
Result Cefuroxime Cefadroxil No. (%) of patients
axetil Adverse event Cefuroxime axetil Cefadroxil
(n = 189) (n = 98)
Satisfactory 135 (97.8) 65 (90.3)b
Cure 132 (95.7) 65 (90.3) Any adverse event 15 (7.9) 6 (6.1)
Improvement 3 (2.2) 0
Gastrointestinal disturbance
Unsatisfactory 3 (2.2) 7 (9.7) Diarrhea or loose stools 7 (3.7) 1 (1.0)
Failure 0 1 (1.4) Abdominal pain 2 (1.1) 0
Recurrence 3 (2.2) 6 (8.3) Nausea or vomiting 0 1 (1.0)
Subtotal 9 (4.8) 2 (2.0)
Subtotal (clinically evaluable) 138 72
Skin disturbance
Diaper rash 4 (2.1) 3 (3.1)
Unevaluable Unspecified rash 1 (0.5) 1 (1.0)
Lost to follow-up 11 8 Subtotal 5 (2.6) 4 (4.1)
Received drug for <5 days 6 0
Withdrawal (other than adverse 1 2 Other
event) Hyperactivity 0 1 (1.0)
Vaginal irritation 1 (1.1)a 0
Subtotal 1 (0.5) 1 (1.0)
Total 156 82
a Percentage of clinically evaluable patients. Laboratory abnormalities, elevated 1 (0.5) 0
b P = 0.009, by comparing satisfactory versus unsatisfactory responses. liver enzymes
a Calculated as the percentage of female patients.

logical outcome section. In addition, the one patient who

was unevaluable because of reasons other than an adverse In the evaluable population, after controlling for differ-
event was the patient who was withdrawn from the study ences in ethnic origin (Caucasian versus all other ethnic
prior to receiving any study drug (classified as receiving drug origins) and investigational centers, there was still a signifi-
for less than 5 days in the bacteriological outcome assess- cant difference in the clinical responses but there was no
ment). No cefadroxil-treated patients were classified as difference in the bacteriological responses.
clinically unevaluable by the investigator because they had Adverse events. In general, adverse events were mild to
received study drug for less than 5 days. The two patients in moderate in severity. One patient discontinued cefuroxime
this category under bacteriological outcome were considered axetil because of diarrhea, which resolved spontaneously
clinical failures because of an adverse event or were with- without further treatment. One patient discontinued ce-
drawn from the study for reasons other than an adverse fadroxil because of a rash, which resolved spontaneously.
event (i.e., personal reasons). For the remaining patients, Adverse events considered by the clinician to be possibly,
satisfactory clinical response rates were higher in cefurox- probably, or almost certainly related to the study drugs
ime axetil than in cefadroxil recipients (97.8 versus 90.3%; P occurred in 7.9 and 6.1% of all cefuroxime axetil and
= 0.009). cefadroxil recipients, respectively (P = 0.641) (Table 6). The
When the patients that were excluded from the "clinical adverse event profiles were similar in both treatment groups
outcome" analysis were reassessed as having unsatisfactory and consisted primarily of gastrointestinal disturbances
outcomes, i.e., an intent-to-treat analysis, the difference in (e.g., diarrhea or loose stools) and diaper rash. Only one
response rates in favor of cefuroxime axetil (81.5 versus patient, a cefuroxime axetil recipient, experienced an abnor-
78.6%) was no longer statistically significant (P = 0.5) (Table mal laboratory value, which consisted of an increase in
5). This can be explained by the addition of more patients serum glutamic oxalacetic transaminase from 30 U/liter at
who were previously excluded from the cefuroxime axetil the initial visit to 48 U/liter at the posttreatment visit and to
group because of poor compliance. However, 86.7 and 52 U/liter 2 weeks later. The patient remained asymptomatic
88.8% of cefuroxime axetil and cefadroxil recipients, respec- throughout this period of time. The patient's mother refused
tively, completed at least 80% of the prescribed therapies. further testing, and the physician observer thought that the
abnormality could be drug related. Otherwise, there were no
clinically significant changes in hematologic or chemistry
parameters.
TABLE 5. Clinical outcome (intent to treat) Drug stop dates showed that study drug was taken for 10
No. (%) of patients days or more by 153 (81.0%) and 84 (85.7%) of cefuroxime
Resulta axetil and cefadroxil recipients, respectively. One of the
Cefuroxime axetil Cefadroxil study medications was taken for 8 to 9 days by 11 (5.8%)
Satisfactory 154 (81.5) 77 (78.6)b cefuroxime axetil recipients and 3 (3.1%) cefadroxil recipi-
Unsatisfactory 35 (18.5) 21 (21.4) ents. Nine (4.7%) cefuroxime axetil-treated patients and two
(2.0%) cefadroxil-treated patients took drug for less than 8
All patients 189 98 days. Of the nine cefuroxime axetil-treated patients who
a Satisfactory was defined as cure or improved. Unsatisfactory was defined took drug for less than 8 days, six withdrew from the study
as all other responses (including unevaluable). because of refusal to take the study medication. In addition,
bp =
0.504, by comparing satisfactory versus unsatisfactory responses. one cefuroxime axetil-treated patient was withdrawn from
 1618 JACOBS ET AL. ANTimICROB. AGENTS CHEMOTHER.

the study because of refusal to take the study medication, Both regimens were well tolerated. These results indicate
but the drug stop date was not recorded. In total, seven that the cefuroxime axetil suspension is safe and efficacious
(3.7%) cefuroxime axetil-treated patients were withdrawn in the treatment of skin and skin structure infections in
for this reason. The disposition of these patients for analysis children.
was discussed above. No cefadroxil-treated patients with-
drew from the study because of refusal to take the study
drug. Drug stop dates were not available for 33 patients (16 ACKNOWLEDGMENTS
cefuroxime axetil recipients, 9 cefadroxil recipients), of We thank Joseph Quinn for performing statistical analyses and
which 14 (7.4%) cefuroxime axetil recipients and 7 (7.1%) Nancy E. Powell for assisting with the execution of this study and
cefadroxil recipients were lost to follow-up. Of the remaining preparation of the manuscript.
patients, none were withdrawn because of refusal to take This study was supported by a grant from Glaxo Inc.
study medication.
REFERENCES
DISCUSSION 1. Ballantyne, F. N. 1985. Comparative efficacy of cefadroxil and
This is the first comparative study of a new formulation of cefaclor in the treatment of skin and soft-tissue infections. Clin.
cefuroxime axetil suitable for oral administration to children Ther. 7:487-491.
2. Dornbusch, K., G. Kronvall, G. E. Goransson, and E. Mortsell.
with skin or skin structure infections. Clinical (97.1%) and 1989. In vitro activity of FCE 22101 against respiratory patho-
bacteriological (97.8%) response rates in the current study gens with reference to production of P-lactamases. J. Antimi-
approximated those reported in adults receiving the tablet crob. Chemother. 23(Suppl. C):31-41.
formulation. The overall clinical improvement rate was 95% 3. Finn, A., A. Straughn, M. Meyer, and J. Chubb. 1987. Effect of
in 97 patients who participated in a noncomparative study dose and food on the bioavailability of cefuroxime axetil.
(5). In a study with a design similar to that of the study Biopharm. Drug Dispos. 8:519-526.
described here, cefuroxime axetil in the tablet formulation 4. Gooch, W. M., III, L. Kaminester, G. W. Cole, et al. 1991.
produced clinical and bacteriological response rates (97 and Clinical comparison of cefuroxime axetil, cephalexin and ce-
96%, respectively) higher than those of cephalexin (89 and fadroxil in the treatment of patients with primary infections of
the skin or skin structures. Dermatologica 183:36-43.
85%, respectively; P < 0.05) and similar to those of ce- 5. Gudgeon, A. C., M. J. Vandenburg, L. J. Wight, G. K. Griffiths,
fadroxil (94 and 93%, respectively; P > 0.05) (4). In other and M. Kelsey. 1987. Is oral cefuroxime axetil suitable for the
comparative studies, the authors concluded that cefuroxime treatment of unidentified bacterial infection of skin and soft
axetil is as effective as amoxicillin-clavulanate (14) and tissue? Br. J. Clin. Pract. 41:954-956.
cefaclor (11). In those trials, clinical and bacteriological 6. Hains, C. S., S. E. Johnson, and K. G. Nelson. 1989. Once daily
response rates from 92 to 97% were achieved. cefadroxil therapy for pyoderma. Pediatr. Infect. Dis. J. 8:648-
In the study described here, bacteriological response rates 649.
were comparable to those achieved with the cefadroxil 7. Harding, S. M., P. E. 0. Williams, and J. Ayrton. 1984.
suspension (approximately 97% in each group), but clinical Pharmacology of cefuroxime as the 1-acetoxyethyl ester in
volunteers. Antimicrob. Agents Chemother. 25:78-82.
responses were higher in cefuroxime axetil recipients (97.8 8. Kendall, M., and A. Stuart. 1979. The advanced theory of
versus 90.3%; P = 0.009). The difference between treatment statistics, vol. 2, p. 580-585. Macmillan Publishing Company,
groups did not appear to be due to a spuriously low response Inc., New York.
rate in the cefadroxil group, because the response rate was 9. Mantel, N., and W. Haenszel. 1959. Statistical aspects of the
consistent with those previously reported in comparative analysis of data from retrospective studies of disease. J. Natl.
trials of patients with skin or skin structure infections (1, 6). Cancer Inst. 22:719-748.
The new cefuroxime axetil suspension was well tolerated 10. National Committee for Clinical Laboratory Standards. 1984.
in the study described here. The incidence and profile of Performance standards for antimicrobial disk susceptibility
adverse events of the cefuroxime axetil suspension closely tests. Approved standard M2-A3. National Committee for Clin-
ical Laboratory Standards, Villanova, Pa.
resembled that of the cefadroxil suspension. Only 7.9% of 11. Parish, L. C., D. M. Cocchetto, K. Werner, D. L. Jungkind, and
children experienced adverse events during cefuroxime ax- J. Witkowski. 1987. Cefuroxime axetil in the treatment of
etil therapy; these adverse events were primarily manifested cutaneous infections. Int. J. Dermatol. 26:389-393.
as gastrointestinal disturbances (e.g., diarrhea or loose 12. Powell, D. A., N. C. James, M. Ossi, M. C. Nahata, and K. H.
stools) or diaper rash. No episodes of nausea or vomiting Donn. 1991. Pharmacokinetics of cefuroxime axetil suspension
were reported in the cefuroxime group. in infants and children. Antimicrob. Agents Chemother. 35:
In this single-blind, randomized study, a suspension for- 2042-2045.
mulation of cefuroxime axetil produced bacteriological re- 13. van Elteren, P. H. 1960. On the combination of independent
sponse rates comparable to those of the cefadroxil suspen- two-sample tests of Wilcoxon. Bull. Int. Stat. Inst. 37:351-361.
14. Watts, H. F., A. H. Williams, and D. M. Cox. 1987. A pilot study
sion (97.1 versus 94.3%) in children with skin or skin of cefuroxime axetil (Zinnat) and Augmentin in the treatment of
structure infections. The clinical response rate was higher in skin and soft tissue infections in general practice. Clin. Trials J.
the cefuroxime axetil group (97.8 versus 90.3%; P < 0.05). 24:356-362.