Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives
Reexamination Certificate
2000-01-11
2001-07-24
Jones, W. Gary (Department: 1655)
Organic compounds -- part of the class 532-570 series
Organic compounds
Carbohydrates or derivatives
C536S024300, C536S023100, C435S006120
Reexamination Certificate
active
06265568
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a probe which is useful for detecting and identifying
Bacteroides fragilis,
the causative bacteria of infectious diseases such as intraperitoneal infection, female genital infection, sepsis and the like.
BACK GROUND ART
Generally, the diseases caused by infection of pathogenic microorganisms are called infectious diseases. In pathology, “infection” is defined as an invasion of pathogenic microorganisms (hereinafter referred to as “bacteria”) and an establishment of footholds for the growth in the host organism by the pathogenic microorganisms. Thereafter, the outbreak of the disease states caused by proliferation of the pathogenic microorganisms in vivo depends upon the relationship between the resistance of the host and the virulence of the bacteria.
Anaerobic bacteria are accounted for 20% of total bacteria strains isolated from various kinds of infectious diseases. In particular, the gram-negative anaerobicbacteria reach to 30 to 50% of the total anaerobic bacteria, and
Bacteroides fragilis
is known to be the most frequently detected strain among them.
In Bacteriology,
Bacteroides fragilis
is taxonomically classified as a nonsporing anaerobic gram-negative bacterium, which is resident within human digestive tract, external genitalia, vagina and urethra. Particularly in colon, it is present at 10
9
to 10
11
per gram of feces, and the number thereof is even higher than that of
Escherichia coli.
Bacterioides fragilis
is the causative bacteria of the endogenous infection of which pathological role is opportunistic. Clinically, this bacteria is detected at the higher rate in intraperitoneal infectious diseases, female genitoinfectious diseases, decubitus, diabetic ulcer, osteromyelitis, bacteremia, the infections in soft tissues of lower half of the body and the pus therefrom (Chemotherapy, Vol. 37, pp1229-1244, (1989);
Rinsho Kagaku,
Vol. 22, pp322-333 (1986)). Furthermore, intraperitoneal abscess is elicited as a result of the involvement of the bacteria when the perforation is caused by trauma in intestinal tracts, especially in colon, surgical procedure, ulcer, cancer, diverticulitis or appendicitis. The presence of anaerobic bacteria has been demonstrated in 90% of the cases of the intrapelvic abscess, and approximately the half of these cases may be related to
Bacterioides fragilis.
Additionally, the anaerobic bacteria are the pathogens for 5 to 10% of bacteremia, and the involvement of
Bacterioides fragilis
in these symptoms has been also known.
Nonsporing anaerobic bacteria such as
Bacteroides fragilis
are generally resistant to the antibiotics of aminoglycosides and polymyxin derivatives. Particularly, since
Bacteroides fragilis
produces &bgr;-lactamase, a tolerance for many of &bgr;-lactam agents such as penicillin and cepham have been gained. Also, a remarkable resistance against ordinarily administered antibacterial agents have been imparted, in comparison with the other anaerobic bacteria. The cephamycin-resistant and imipenem-resistant lines have been discovered as well (see, “
Kagaku Ryoho no Ryoiki
”, Vol. 6, No. 9, 1915-1925 (1990) ). Therefore, it is extremely difficult to treat the patient, once the infection by such bacteria is established. The higher mortality has been reported, particularly in the cases that the infection lead to sepsis. Additionally, the infection of these bacteria may rather be drawn as “replacement of bacteria” through pre-administration of antibiotics before the surgical procedures.
Thus, there is a continuous need for the establishment of the method for rapid diagnosis of the infectious disease caused by
Bacteroides fragilis,
since the accurate diagnosis at an early stage of the infection and the selection of the appropriate agents are extremely crucial for the therapeutic treatment.
Infections caused by anaerobic bacteria are generally initiated by the invasion of indigenous bacteria into the tissue through a local rupture.
In the conventional diagnostic procedure, it is mandatory to: (1) analyze the clinical symptoms; (2) culture the specimen; and (3) Gram stain the bacteria which are found in the specimen, and then the therapeutic strategy is determined after these items are sufficiently examined. Actually, the following findings may tentatively suggest the suspected
Bacteroides fragilis
infection:(1) gram-negative bacteria in the specimen detected by direct Gram stain; (2) foul-smelling specimen; (3) infections found in the parts under diaphragm; (4) infectious diseases which are not effectively alleviated by any treatment using penicillin or cephalosporin derivative agent; (5) the patient suffering from diabetic ulcer, decubitus, or bacteremia. However, it is necessary to search for the correct bacteria which caused the infection, then the bacteria must be identified in order to attain the accurate diagnosis. Thereafter, the appropriate antibiotics adequate for the treatment of thus identified bacteria should be administered. Therefore, the rapid and accurate method to identify the causative bacteria has been desired in the clinical field.
In addition, the identification of the causative bacteria has been increasingly important in recent years, because of the discoveries of the several drug resistant causative bacteria.
However, the identification of the causative bacteria generally involves certain difficulties in actual clinical cases. In particular when the causative bacteria are anaerobic ones, every effort should be made in order to avoid the contamination of indigenous bacteria, and the exposure of the bacteria to air and the dryness. In more detail, identification of the causative bacteria in the specimen from the patient suspected as an anaerobic bacteria infection, the specimen such as blood, spinal fluid, pleural fluid, ascites, puncture fluid from abscess, or samples from pus or secreted materials is collected and subjected to the analysis. Since the causative bacteria are known as indigenous bacteria in human lower intestine and vagina, the specimen has to be obtained most carefully for avoiding the contamination of the indigenous bacteria, especially in the cases of the infections observed in these parts. Once the specimen is collected from the patient, it must be kept in the container designed suitable for anaerobic bacteria analysis, which immediately protects the specimen from dryness and the contact with oxygen. In general procedure to identify the causative bacteria, thus obtained specimen is observed macroscopically and examined on the presence of odor, then followed by direct Gram stain on smear, and culture in the selected medium under an aerobic condition for 48 hours. Whereas, according to this procedure, a long proliferation period of the bacteria from the specimen, and further, 3 to 4 days of incubation period would be required to attain the result of the drug sensitivity test. In addition, the cases in which
Bacteroides fragilis
can be detected as independently existing causative bacterial species are relatively rare, and 70 to 80% of the cases in which
Bacteroides fragilis
was detected were reported to be the combined cases caused by plural kinds of bacteria. In some cases, the existing
Bacteroides fragilis
may not be detected because the specimen is treated aerobically when the detection of the aerobic bacteria is intended. Additionally, in cases of the diagnosis of the patients who had already been treated with a large dose of antibiotics when the possible infection was suspected, the growth and proliferation of the bacteria may be prevented even if the bacteria are present in the specimen. Accordingly, the feasibility of successful culture of the bacteria from these specimen may become extremely low.
Furthermore, alternative subroutine methods developed heretofore may include: an instrumental analysis method of constituents of bacteria and metabolic products from bacteria (See Yoshimi Benno, “Quick identification of bacteria with gas chromatography”,
Rinsho Kensa,
Vol. 29, No.12 pp.1618-1623, November 1985, Igaku
Abe Kanako
Keshi Hiroyuki
Matsuhisa Akio
Ueyama Hiroshi
Fuso Pharmaceutical Industries Ltd.
Golderg Jeanine
Jones W. Gary
Marshall O'Toole Gerstein Murray & Borun
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