Quality control parameters for cefditoren susceptibility tests

Quality control parameters for cefditoren susceptibility tests

Concise Communications the first study. Guess [10] found that 20 in 100000 children 93 chickenpox before the first year of age and herpes zoster in...

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Concise Communications

the first study. Guess [10] found that 20 in 100000 children

93

chickenpox before the first year of age and herpes zoster in

under the age of 5 fall ill, and 63 in 100 000 of persons between

children was not analyzed, because the number of children with

the ages of 15 and 19. Herpes zoster was significantly more

chickenpox at the age ofless than 1 year was insufficient to form

frequent in children with acute lymphocytic leukemia. Accord-

a sample.

ing to the data from this study, the risk factor for childhood

Even though herpes zoster is a disease of the elderly, it is not

herpes zoster was chickenpox before the first year of age.

all that rare in children; however, the course of the disease is

Another study [11], which was conducted a few years ago,

mainly mild and without sequelae.

reported an even higher incidence ofherpes zoster; it affects 160 in 100 000 persons younger than 19. Herpes zoster most frequently appeared in the thoracic region. The course of the disease was mainly mild, and none of the patients had post-herpetic neuralgia. A significantly higher number of complications were observed in adult patients [3]. The data we collected do not differ from those of the abovementioned studies. The number of patients was found to increase with age. The interval between chickenpox and herpes zoster was 5.6 years on average. In a study conducted on the popnlation of Iceland, on average slightly more than 8 years passed from chickenpox to the appearance of herpes zoster, but adolescents with herpes zoster aged up to 19 were also included. In all of our patients, the course of the disease was extremely mild and there were no complications. It is therefore disputable whether treatment with acyclovir is justified, apart from exceptional cases (e.g. in severely immunocompromised children). In the children from this study as well, herpes zoster was most often located in the thoracic area and only in one child in the ophthalmic area. In adnlts, however, thoracic herpes zoster is found in only half of the cases and cranial herpes zoster in over 10% of patients [5]. In children whose mothers had chickenpox during pregnancy, herpes zoster may appear as early as the first year oflife. In only one of86 children did the mother have chickenpox during pregnancy, and herpes zoster appeared very soon after the first year of life. The immune system of the fetus is undoubtedly immature, which, in the opinion of some, is the reason for the early appearance of the disease [2]. The correlation between

REFERENCES 1. Straus SE. Introduction to Herpesviridae. In: Mandell GL, Bennets JE, Dolin R, eds. Principles and Practice of Infectious Diseases, 4th edn, Vol. 2. New York: Churchill Livingstone, 1995: 1330-5. 2. Miller E, Marshall R, Vurdien J. Epidemiology, outcome and control of varicella-zoster infection. Rev Med Microbial 1993; 4: 222-30. 3. Weller TH. Varicella and herpes zoster. Changing concepts of the natural history, control, and importance of not-so-benign virus. N Engl] Med 1983; 309: 1362-8. 4. Straus SE, Ostrove JM, Inchaupse G et a1. Varicella-zoster infections. Biology, natural history, treatment, and prevention. Ann Intern Med 1988; 108: 221-37. 5. Ragozzino M\JII, Melton MJ, Kurland LT, Chu Cp' Pery HO. Population-based study of herpes zoster and its sequelae. Medicine 1982; 61: 310-16. 6. Wutzler P, Doerr H\JII, von EssenJ et al. Epidemiology of herpes zoster. Biotest Bull 1997; 5: 301--6. 7. Donahue JG, Choo P\JII, Manson JE, Platt R. The incidence of herpes zoster. Arch Intern Med 1995; 155: 1605-9. 8. Mazur MH, Dolin R. Herpes zoster at NIH: a 20-year experience. Am] Med 1978; 65: 738-4. 9. Latif R, Shope TC. Herpes zoster in normal and immunocompromised children. Am] Dis Child 1983; 137: 801-2. 10. Guess HA, Broughton DD, Melton LJ, Kurland LT. Epidemiology of herpes zoster in children and adolescents: a population-based study. Pediatrics 1985; 76: 512-17. 11. Petursson G, Helgason S, Gudmundsson S, Sigurdsson A. Herpes zoster in children and adolescents. Pediatr Infect Dis] 1998; 17: 905-8.

Quality control parameters for cefditoren susceptibility tests P C. Fuchs', A. L. Barry, S. D. Brown and M. M. Traczewski

The Clinical Microbiology Institute, 9725 SW Commerce Circle, Wilsonville, OR 97070, USA *Tel:

+1 503

682 3232

Fax:

+1 503

682 2065

E-mail: [email protected]

Accepted 30 November 2000

Cefditoren is a new expanded-spectrum orally administered

[1]. Its antimicrobial spectrum includes both Gram-positive and

cephalosporin currently undergoing clinical trials in the USA

Gram-negative species, but it is noteworthy for its particnlar

© 2001 Copyright by the European Society of Clinical Microbiology and Infectious Diseases, GMI, 7, 88-102

Clinical Microbiology and Infection, Volume 7 Number 2, February 2001

94

Table 1 Distribution of MICs for six QC strains" Broth microdilution MICs (mg(L) Organism (ATCC No.)

No. of tests

Escherichia coli (25922) Staphylococcus aureus (29213) Streptococcus pneumoniae (49619) H influenzae (49247) H influenzae (49766)

594

0.004

0.008

0.016

0.03

0.06

279

245

600 500

5

300 45

499

424

28

2

"Number of times each MIC was reported; values in bold are within the proposed QC limits for each strain.

potency against the major respiratory pathogens Haemophilus infiuenzae and Streptococcus pneumoniae [1,2]. In order to ensure

for H. infiuenzae ATCC 49766, and three lots for H. infiuenzae ATCC 49247. These media were freshly prepared and stored at

accurate in vitro susceptibility tests with this drug, quality

<;- 60°C until used (up to 14 days). Serial dilutions of

control (QC) parameters are necessary for the standard QC

cefotaxime or cefuroxime were prepared in one lot of broth

organisms. In the course ofour in vitro studies of cefditoren, we

as control drugs. Three lots of Mueller-Hinton agar (MBA)

have conducted a multilaboratory study to determine the QC parameters for cefditoren when tested by the National Com-

from three different manufacturers were used for disk diffusion tests, along with two lots of 5-J-lg cefditoren disks prepared by

mittee for Clinical Laboratory Standards (NCCLS) methods for

two different manufacturers. The MHA was supplemented with

broth microdilution [3] and disk diffusion [5] susceptibility tests.

5% sheep blood or HTM supplements for testing S. pneumoniae

The design of these studies exceeded the minimum require-

or H. infiuenzae. HTM agar was freshly prepared and used

ments of the NCCLS [4]. Ten North American medical centers participated in each study. Each laboratory performed the broth

within 14 days. Cefotaxime 30-J-lg disks or cefixime 5-J-lg disks served as controls. On each of 10 separate days, all participants

micro dilution and disk diffusion tests as outlined by the NCCLS

inoculated one microdilution tray and three different MBA agar

[3,5]. Broth microdilution trays were prepared to contain serial

plates for each organism tested. This resulted in a total of 600

dilutions of cefditoren with concentrations ranging from 0.004

disk diffusion zone diameter measurements for each QC strain

to 32 mg/L in each of six different lots of cation-adjusted

tested, 600 MIC determinations for each non-fastidious QC

Mueller-Hinton broth (CAMHB) from four different manufacturers for testing non-fastidious strains, and five lots of

strain, 500 MIC determinations for the S. pneumoniae QC strain and H. infiuenzae ATCC 49766, and 300 MIC determinations

CAMHB with 3% lysed horse blood for Streptococcus pneumoniae,

for H. infiuenzae ATCC 49247. Whenever the control drug

five lots with Haemophilus Test Medium (HTM) supplements

results were outside the NCCLS range, the corresponding

Table 2 Distribution of zone diameters for six QC strains" Disk diffusion zone diameters (mm) Organism

No. of

(ATCCNo.)

tests

EC

590

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

14

76

175

195

89

34

7

34

108

188

149

51

23

17

5

597

3

5

21

45

77

120

154

98

44

19

11

576

11

21

75

106

110

122

66

40

8

8

3

36

37

4

2

(25992) SA

590

10

(25923) SP (49619) HI (49247) "Number of times each zone diameter was reported; values in bold are within the proposed QC limits for each strain. EC,Escherichia coli; SA, Staphylococcus

aureus; SP,Streptococcus pneumoniae; HI, Haemophilus influenzae.

© 2001 Copyright by the European Society of Clinical Microbiology and Infectious Diseases, GMI, 7, 88-102

Concise Communications

95

Table 3 Recommended QC ranges for cefditoren" and percentage of results in range MICs (mg(L)

Zone diameters (mm)

Organism (ATCC No.)

Range

% in range

Range

% in range

Escherichiacoli (25922) Staphylococcus aureus (29213) Staphylococcus aureus (25923) Streptococcus pneumoniae (49619) Haemophilus influenzae (49247) Haemophilus influenzae (49766)

0.12-1.0 0.25-2.0

100 100

22-28

100

a

NA

20-28 27-35 25-34

NA

0.016-0.12 0.06-0.25 0.004-0.016

100 100 99.6

98.3 98.7 98.3

NR

These QC ranges were approved by the NCClS in June, 1999. NA, not applicable; NR, no recommendations (results off-scale or zones too large).

J.

cefditoren results were omitted from the calculations even

Center, Worcester, MA, USA; M.

though these would not have influenced the cefditoren pro-

General Hospital, Boston, MA, USA; D. Goldman, Children's

posed ranges. Colony counts were performed on the growth

Hospital and Medical Center, Boston, MA, USA; D. Hardy,

control suspension on each test day to ensure appropriate inoculum density.

Ferraro, Massachusetts

University of Rochester Medical Center, Rochester, NY, USA;

J. Hindler,

UCLA Medical Center, Los Angeles, CA, USA; S.

The distribution of MICs and zone diameter results with

Jenkins, Carolinas Medical Center, Charlotte, NC, USA; C.

these control organisms are summarized in Tables 1 and 2.

Knapp, Trek Diagnostic Systems, Westlake, OH, USA; G.

There were no appreciable differences in these distributions

Overturf, University of New Mexico Medical Center, Albu-

when the results were stratified by media lot or laboratories.

querque, NM, USA; M. Pfaller, University ofIowa, Iowa City,

The QC organisms tested, the proposed ranges and the per-

lA, USA; R. Rennie, University of Alberta Hospital, Edmon-

centage of results falling within these ranges are summarized in

ton, Alberta, Canada; M. Saubolle, Good Samaritan Hospital,

Table 3. A four-dilution MIC range was proposed for most

Phoenix AZ, USA; and J. Washington, The Cleveland Clinic,

strains because the mode fell between two adjacent concentra-

Cleveland, OH, USA.

tions that were tested. One laboratory also performed cefditoren agar dilution tests with each QC strain on 15 separate days, and all MIC results fell within these proposed ranges. The MIC QC range for H. influenzae ATCC 49247 was approved by the NCCLS in June 2000; all other QC ranges listed in Tables 1 and 2 for both disk diffusion and dilution tests were approved by the NCCLS subcommittee on antimicrobial susceptibility tests in June 1999.

ACKNOWLEDGMENTS This study was supported by a grant from TAP Pharmaceuticals. Portions of this material have been previously presented at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, USA, 26-29 September 1999, as Abstract 2324. Participants included: M. Bauman, Providence St Vincent Medical Center, Portland, OR, USA; B.

Brogden-Torres, University of Massachusetts Medical

REFERENCES 1. Felmingham D, Robbins MJ, Ghosh G et al. An in vitro

characterization of cefditoren, a new oral cephalosporin. Drugs cu« Res 1994; 20: 127-47. 2. Jones RN, Biedenbach DJ, Croco MAT, Barrett MS. In vitro evaluation of a novel orally administered cephalosporin (cefditoren) tested against 1249 recent clinical isolates of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. Diagn Microbial Infect Dis 1998; 31: 573-8. 3. National Committee for Clinical Laboratory Standards. Methods of Exp

dilution antimicrobial susceptibility tests for bacteria that grow aerobically,

4th edn. Approved Standard M7-A4. Wayne, PA: NCCLS, 1997. 4. National Committee for Clinical Laboratory Standards. Development of in vitro susceptibility testing criteria and quality control parameters. Tentative Guideline, M23-T3. Wayne, PA: NCCLS, 1998. 5. National Committee for Clinical Laboratory Standards. Performance standards for antimicrobial disk susceptibility tests, 6th edn. Approved Standard M2-A6. Wayne, PA: NCCLS, 1997.

© 2001 Copyright by the European Society of Clinical Microbiology and Infectious Diseases, GMI, 7, 88-102