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PubMed1988

In vitro testing of the antibacterial activity of fosfomycin trometamol against urinary pathogens.

The activity of fosfomycin trometamol (FOT) was compared with that of cotrimoxazole (COT) and norfloxacin (NOR) using urine as medium and 10(7) bacteria as inoculum, conditions as close as those found by the administration of the drugs in vivo during the course of a urinary tract infection. The minimum inhibitory concentrations (MIC) of all antibiotics against 100 strains isolated from urinary tract infections were found to be higher than the breakpoint. Concentrations of FOT corresponding to mean and maximal values found in urine after single dose administration within the 0-48 h interval killed the great majority of strains. COT and NOR, when tested under similar conditions, exhibited an antibacterial activity lower than and equal to that of FOT, respectively. In several strains belonging to different species the frequency of mutation to resistance to 2000 and 1000 micrograms/ml of FOT was very low (greater than 10(-7], whereas it was relatively high (1 x 10(-5) to 1 x 10(-7] for 150 micrograms/ml, the two former and the latter being the respective maximal, mean and minimal values found in urine after administration of a single dose.

Bacteria↗
PubMed1987

Stratified duration of prophylactic antimicrobial treatment in emergency abdominal surgery. Metronidazole-fosfomycin vs. metronidazole-gentamicin in 381 patients.

Consecutive adult patients requiring emergency abdominal surgery were randomly allocated to preoperative treatment with metronidazole-gentamicin (M-G) or metronidazole-fosfomycin (M-F). Postoperative continuation of antibiotics depended on the estimated risk of septic complications. Peroperatively the cases were stratified as group A, acute inflamed appendicitis, or absence of septic disorder--no postoperative antibiotics, group B, gangrenous appendicitis or cholecystitis or intestinal obstruction without resection, or operations with contamination regarded as minor (gastrotomy or enterotomy)--three further doses of antibiotics, or group C, perforated appendicitis, perforation of the alimentary tract, generalized peritonitis or gross contamination--antibiotics continued for 5 days. Assessment for septic complications was made in 381 patients (191 M-G, 190 M-F). The total incidence was 4.8% (M-G 7.8%, M-F 1.6%, p less than 0.01). The difference was mainly due to higher infection rate in patients stratified to group C and randomized to M-G. Stratification thus permitted restricted duration of antibiotic treatment with a low septic complication rate, significantly less with M-F than with M-G regimen.

Abdomen, Acute↗
PubMed1987

[Treatment of post-traumatic and post-neurosurgical bacterial meningitis with ceftriaxone alone or in combination with fosfomycin].

From 1984 to 1986, 13 patients (10 adults, 3 children) with bacterial meningitis following neurosurgery or traumatism were given ceftriaxone alone 6 times at a dose of 40 mg/kg one IV injection per day, or in association 7 times with fosfomycin at a dose of 200 mg/kg/day, 3 IV perfusions every 4 h. The bacteriological diagnosis was confirmed in 9 cases (3 Staphylococcus aureus, 4 Streptococcus pneumoniae, 1 Klebsiella, 1 Peptococcus). In vitro neither synergy nor antagonism were observed between the two antimicrobial agents. The acute infections episode resolved in all patients except on who died with a negative CSF culture. One superinfection meningitis with Achromobacter was seen. CSF concentrations of ceftriaxone were assayed and found to be comparable with those reported by most authors. Tolerance was excellent for all our patients.

Adult↗
PubMed1988

[Influence of a fosfomycin combination on the anti-tumor effect of CDDP].

To elucidate the influence of fosfomycin (FOM) on the anti-cancer effect of cisplatin (CDDP), experimental chemotherapy of CDDP with or without FOM was performed. A human lung cancer cell line, HLC-1 serially transplanted into nude mice was treated with CDDP 10 mg/kg (i.p.). Tumor doubling time in CDDP group and CDDP + FOM group are 26.78 +/- 6.3 days and 33.90 +/- 11.82 days respectively, and they are significantly elongated compared to control group. Serum NAG level in CDDP + FOM group was significantly lowered. Therefore, we concluded that anti-tumor effect of CDDP was not diminished by FOM combination.

Adenocarcinoma↗
PubMed1987

[The clinical effect of fosfomycin on cystitis].

Fosfomycin (FOM) is an antibiotic which inhibits phospho(enol)pyruvic acid transferase. Fifty-five patients with cystitis were treated with the drug for 7 days, at oral doses of 1 g for 3 times a day. Adult females under 70 years of age, visiting the clinic within 2 weeks after the onset, were classified as cases with typical simple cystitis with confirming the bladder irritability, pyuria and bacteriuria. The treatment was effective for 95.0% of these cases. Two cases with atypical cystitis caused by Klebsiella pneumoniae poorly responded to the drug.

Administration, Oral↗
PubMed1986

[Experimental study of the ototoxicity of fosfomycin].

Two tenths ml of 5% fosfomycin sodium solution (10 mg) was injected into the tympanic cavity of guinea pigs once a day for 7 days. Auditory brain stem response (ABR) was performed to examine the effect of the drug on the experimental animals. Additionally, a scanning electron microscopic study was also performed to observe the effect of the drug on outer hair cells of the organ of Corti and on vestibular sensory epithelia. No degenerative changes were observed in outer hair cell cilia of the organ of Corti and the vestibular sensory cilia at 1 day, 7 days, 14 days and 1 month after injection. No changes of the threshold of ABR were also noticed.

Animals↗
PubMed1986

[Treatment of neurosurgical bacterial meningitis using the combination of ceftriaxone-fosfomycin].

16 patients with bacterial meningitis following a neurosurgical procedure were given a combination of ceftriaxone and fosfomycin. 8 microorganism were isolated: 2 Staphylococcus epidermidis, 1 Staphylococcus aureus, 1 Neisseria meningitidis, 1 Streptococcus pneumoniae, 1 Haemophilus influenzae, 1 Serratia marcescens and 1 Aeromonas hydrophila. No pathogen was identified in the remaining cases. All of the isolated strains were susceptible to both antibiotics. In vitro, neither synergy nor antagonism were observed between the two antimicrobial agents. The acute infectious episode resolved in all patients. One relapse only was observed, in a patient with meningitis related to a ventricular shunt, and successfully treated by the same therapeutic schedule associated with removal of the tubing. Lastly, CSF concentrations of both antibiotics were assayed and found to be comparable with those reported by most author.

Adult↗
PubMed1978

[Fosfomycin, a new antibiotic drug (author's transl)].

After i.v. injection of 25 mg/kh/BW and 50 mg/kg/BW to children age 5--6, no difference in the pharmakokinetic action can be found. The pattern of the plasma concentration allows the assumption of a 2 compartment model. There is a decrease of the plasma concentration in the steady state with a half life of 1,6 and 1,7 hours resp. The total volume of distribution is 30% of the body weight. Fosfomycin is eliminated by glomerular filtration only. The drug is not metabolished, as 98% and 95% of the dosage are recovered in active form in the urine. In premature and newborn babies there was a 1 compartment model assumed after i.v. administration of 25 mg/kg/BW. The distribution volumes with 41% of the body weight considerably greater then in older children. Elimination is again by glomerular filtration only. Plasma levels are decreasing considerably slower so that less of the drug is excreted in the 24-hour-urine. There is a sufficient penetration of the drug into the CSF. Bactericidal levels are reached within 48 hours by cumulation of the drug.

Age Factors↗
PubMed1986

[Investigation on effectiveness and safety of fosfomycin in treatment of patients with allergy induced by antibacterial agents].

Twenty-four patients with urinary tract infections were treated with fosfomycin (FOM) to evaluate its effectiveness and safety. They all had shown allergic reactions, mainly to beta-lactams. Lymphocyte stimulation test (LST), leukocyte migration inhibition test (LMT), passive cutaneous anaphylaxis (PCA) and the precipitin reaction were performed to test whether FOM would also cause an allergic reaction. FOM was judged by the physician-in-charge to be effective in all 6 patients (100%) with acute simple cystitis and 8 (72.7%) of 11 patients with chronic complicated urinary tract infections. The drug was also effective in 15 (83.3%) of 18 patients with epididymitis, etc. Regarding the usefulness of FOM, it was judged to be useful in 21 (91.3%) of 23 patients. FOM was very useful in 8 (34.8%) of these 23. In patients tested for LST, the value was lower in cases given FOM than in cases given ampicillin (ABPC), cefazolin (CEZ) or latamoxef (LMOX); there was an especially significant (p less than 0.01) difference with ABPC. All the drugs tested were negative for the LMT, PCA and precipitin reaction tests. No subjective or objective abnormalities were attributed to the FOM treatment, and there were also no abnormal laboratory test values. FOM was evaluated to be an effective and safe antibacterial agent without in vitro or clinical allergic reactions.

Adolescent↗
PubMed1986

[Clinical efficacy of fosfomycin in the treatment of orofacial infections].

In this study, the clinical efficacy of fosfomycin (FOM) for various types of orofacial infections was evaluated in 40 patients, 27 males and 13 females, ranging in age from 16 to 71 years. All but 1 patients were treated orally with FOM at 500 mg 4 times daily. The total duration of treatment varied from 3 to 31 days. Basically, clinical effectiveness was determined by the criteria of Japanese Society of Oral and Maxillofacial Surgeons. Two cases, in which the final therapeutic evaluation could not be obtained because of side effects, were excluded from the analysis. The results were rated as excellent in 7, good in 26 and poor in 5 out of 38 evaluable cases, with an efficacy rate reaching 86.8%. From the clinical standpoint, the differences of efficacy were further discussed in terms of phase, type and intensity of infections respectively. In 9 (10 times) of 40 cases, the bacteriological analyses could be made. The identification of organisms obtained from abscess in each case demonstrated mixed infections caused by both aerobic and anaerobic organisms in more than half cases. From their sensitivity tests, it should be pointed out that FOM was efficiently active against aerobic and anaerobic Gram-positive organisms, while it was ineffective for the anaerobic Gram-negative organism, Bacteroides, although the role of the latter generally remained still obscure in orofacial infection. No serious side effects were observed except for mild diarrhea in 3 patients and a slight elevation of serum glutamic oxaloacetic transaminase (GOT) level in 1 patient. This study conclusively demonstrated that FOM was a useful and safe antibiotic in the treatment of patients with various orofacial infections.

Adolescent↗
PubMed1986

[Transfer of fosfomycin into human burn blister fluid and its pharmacokinetic analysis].

Fosfomycin (FOM) (50 mg/kg) was administered to burned patients by intravenous bolus injection. Burn blister fluid and serum were taken during 8 hours after injection, and concentrations of FOM in burn blister fluid and serum were determined by bioassay using Proteus sp. (MB-838) as the test organism. The serum concentrations of FOM were 257 +/- 34.6 micrograms/ml at 15 minutes, 222 +/- 34.8 micrograms/ml at 30 minutes, 166 +/- 34.6 micrograms/ml at 1 hour, 114 +/- 43.9 micrograms/ml at 2 hours, 79.5 +/- 34.9 micrograms/ml at 3 hours, 63 +/- 36.4 micrograms/ml at 4 hours, 44.3 +/- 27.6 micrograms/ml at 5 hours, 29.6 +/- 20.9 micrograms/ml at 6 hours and 17.9 +/- 12.8 micrograms/ml at 8 hours after the injection. FOM concentrations in burn blister fluid were 64.4 +/- 18.1 micrograms/ml at 30 minutes, 77 +/- 26.0 micrograms/ml at 1 hour, 71.6 +/- 24.7 micrograms/ml at 2 hours, 64.8 +/- 23.6 micrograms/ml at 3 hours, 43.2 +/- 8.8 micrograms/ml at 4 hours, 24.8 +/- 7.9 micrograms/ml at 6 hours and 17.9 +/- 10.5 micrograms/ml at 8 hours after the injection. The obtained data were analysed pharmacokinetically. The serum levels were analysed by a two-compartment model, and the transfer of FOM into burn blister was analysed by a modified deconvolution method. In results, Tmax and Cmax of FOM levels in burn blister fluid were calculated as 1.3 hours and 80.9 micrograms/ml, respectively. The transfer rate constant of FOM from serum to burn blister fluid (K1) and that from burn blister fluid to serum (K2) were calculated as 0.612 hr-1 and 1.10 hr-1, respectively.

Adult↗
PubMed1985

[Effect of fosfomycin on auditory organs and its transfer to cochlear lymph following application of its solution into a middle ear cavity].

Male guinea pigs were given 0.1 ml of 2, 3 or 5% fosfomycin (FOM) ototopical solution once a day for 5 days into a middle ear cavity through artificially perforated ear drum. Kanamycin A (KM) was used at 2% ototopical solution as control drug. Four animals of each group were sacrificed under pentobarbital anesthesia to isolate the cochlea 10 days after the final application. The cochlea was washed with 0.1 M phosphate buffer (pH 7.0), followed by fixing with 2.5% glutaraldehyde and 1% osmic acid. Cochlear specimens were prepared by standard method for scanning electron microscopic observation. The scanning electron microscopic observations revealed some damages in outer and inner hair cells, such as partial deformation or loss of auditory hair in hair cells, but these damages were not correlated to drug treatments. In order to determine the transfer of FOM and KM from middle ear cavity to cochlear lymph in male guinea pigs, the cochlear lymph was collected 0.5, 1, 2 and 4 hours after an application of 0.1 ml of 3 or 5% FOM and 2% KM ototopical solution into a middle ear cavity, followed by estimating content of these antibiotics in the lymph. The results showed the peak concentration in lymph at 1 to 2 hours after an application of 3% FOM was lower than that after 2% KM, but the AUC of 3% FOM was higher than that of 2% KM. The AUC value of FOM was dependent on the applied concentration of FOM. The value of half-life time was about 4.8 hours at FOM and about 2.3 hours at KM.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1985

Antibacterial activity of fosmidomycin on chromosomic and plasmid-determined fosfomycin-resistant strains.

The antibacterial activity of fosmidomycin (Fm) on chromosomic and plasmid-determined fosfomycin-resistant (For) strains of Gram-negative bacteria was studied. Presence of For-plasmids did not protect host bacteria from the antibiotic effect of Fm. In clinical isolates Fm was more active than Fo in 67% of the strains whereas Fo was more active for only 2%; 76% of the strains showed cross resistance to both antibiotics. The Fmr character was not transferred by conjugation. For mutants selected in the hospital environment as well as in the laboratory did not always show cross resistance with Fm, and the alterations in the transport systems of both antibiotics were not the only mechanism of cross resistance.

Anti-Bacterial Agents↗
PubMed1985

[Fundamental and clinical studies on fosfomycin sodium in the field of obstetrics and gynecology].

Fosfomycin sodium (FOM-Na) was studied both fundamentally and clinically in the field of obstetrics and gynecology with following results. It showed good transference into the uterine tissues when given intravenously. The peak concentrations achieved in the uterine tissues following intravenous administration of 2 g of FOM-Na were 26.56 to 53.48 micrograms/g when given as one shot injection and 20.16 to 39.47 micrograms/g as drip infusion. In the serum of vein and uterine artery, peak concentrations of 163.6 to 143.40 micrograms/ml and 120 to 113.12 micrograms/ml were reached following one shot injection and drip infusion, respectively. In general, FOM-Na concentrations in the uterine tissues showed similar changes as those observed for serum concentrations. Clinically, FOM-Na was used in the treatment of 17 cases of obstetrical and gynecological infections at 2 g per dose twice daily as intravenous drip infusions. In all of these cases, good clinical efficacy was obtained. No side effects were observed.

Adnexa Uteri↗
PubMed1985

[Clinical studies on fosfomycin sodium following intravenous administration (tissue concentration and clinical efficacy)].

Fosfomycin (FOM) is a synthetic antibiotic having a unique structural formula and bactericidal mechanism and a broad spectrum of antimicrobial activity against various bacterial species. It has higher activity in vivo than in vitro. As therapy, FOM-Na in a daily dose of 4 g (2 g X 2) was given by intravenous drip infusion for 5 to 10 days to 6 cases with infectious diseases (2 cases of acute cholecystitis, 3 cases of acute localized peritonitis due to phlegmonous appendicitis and 1 case of acute diffuse peritonitis due to perforative appendicitis). The clinical response was rated as "excellent" in 1 case, "good" in 4 cases, "fair" in 1 case and "poor" in none. No adverse effects were observed in any of the patients. Six clinical isolates were obtained, and these consisted of 4 strains of Escherichia coli and 1 strain each of Klebsiella pneumoniae, and Bacteroides fragilis. The MICs of FOM were from 6.25 to 12.5 micrograms/ml for E. coli, 50 micrograms/ml for K. pneumoniae, and 100 micrograms/ml for B. fragilis. FOM-Na was administered to the 6 cases intravenously in a dose of 2 g before surgery, and tissue specimens and body fluid samples were taken during the operation. The FOM concentration was determined by bioassay with a Proteus sp. (MB 838) as the test organism. The mean FOM concentration in bile from the common bile duct was 61.85 +/- 17.13 micrograms/ml (n = 5) at 95 to 108 minutes after FOM-Na intravenous bolus injection. The mean FOM concentration in the gall bladder bile was 80.06 +/- 92.36 micrograms/ml, while that in the gall bladder wall was 146.65 +/- 39.10 micrograms/g. The mean FOM concentration in purulent ascites was 58.20 +/- 13.29 micrograms/ml, 36.22 +/- 14.63 micrograms/g in the appendix wall and 12.64 +/- 11.34 micrograms/ml in pus in the appendix. The FOM concentrations in the infected tissues and body fluids thus exceeded the MICs of FOM for the pathogenic bacteria. Therefore, FOM-Na appears to be a very useful drug when used for chemotherapy of infections encountered in the surgical field.

Acute Disease↗
PubMed1979

[Toxicological studies on fosfomycin-Na salt. I. Acute toxicity in mice and rats (author's transl)].

The acute toxicity of sodium fosfomycin (FOM-Na), a new antibiotic in ICR mice and Wistar rats has been investigated. The LD50 values in mice were: 1,230 (male), 1,225 (female) mg/kg by i.v.; 2,175 (m), 2,467 (f) mg/kg by i.p.; 2,625 (m), 2,662 (f) mg/kg by i.m.; 5,100 (m), 6,150 (f) mg/kg by s.c. and 8,020 (m), 7,300 (f) mg/kg by p.o. The LD50 values in rats were: 1,650 (m), 1,560 (f) mg/kg by i.v.; 2,060 (m), 2,000 (f) mg/kg by i.p.; 2,630 (m), 2,460 (f) mg/kg by i.m.; 5,100 (m), 4,320 (f) mg/kg by s.c. and 4,700 (m), 4,550 (f) mg/kg by p.o. Animals dosed only i.v. died within 2 minutes. Signs of toxicity in mice or rats given FOM-Na were similar and included motor activity depression, reduced respiration and occasionally tremors. Surviving mice or rats given FOM-Na developed no pathological changes of the drug specificity.

Administration, Oral↗
PubMed1979

[Effect of fosfomycin-Na on reproductive performance of rats. II. Fertility test (author's transl)].

The fertility study of fosfomycin-Na (FOM-Na) was undertaken in Wistar rats. FOM-Na was administered intraperitoneally at dose levels of 125, 250, 750 and 1,500 mg/kg/day. The male rats were continuously treated with FOM-Na from 63 days before mating and the females were treated from 14 days before mating. The males and females were treated through the mating period and then the pregnant rats were treated until 7 days of gestation. All pregnant rats were sacrificed on day 20 of gestation and then their fetuses were examined for external, visceral and skeletal observation. Mean body weight of males decreased and 6 males and 3 females died in the maximum dose. However, no significant differences were found between treated groups and the control with regard to fertility rate and pregnant rate. External, visceral and skeletal anomalies related with FOM-Na treatment were not observed. In this experiment, no effects of FOM-Na for reproductive performance in rats were observed.

Abnormalities, Drug-Induced↗