7432-s and Acute-Disease

This double-blind, multicentre study was performed at nine centres on a total of 171 patients who presented with fever (> 38.5 degrees C) and signs of acute pyelonephritis. All were initially treated with intravenous cefuroxime. After 2-3 d, when the fever had subsided and urinary culture had revealed growth of Gram-negative bacteria ( > 10(7) colony-forming units per litre), treatment was changed to oral administration of ceftibuten 200 mg b.i.d. or norfloxacin 400 mg b.i.d. for 10 d. The patients were followed for signs of bacterial or clinical relapse 7-14 d after the end of treatment. The initial clinical and bacteriological cure was excellent in both groups, but there were significantly fewer bacterial relapses after oral treatment with norfloxacin than with ceftibuten in acute febrile pyelonephritis initially treated with intravenous cefuroxime. The causal strain was eradicated in 75% of patients (73% of males, 76% of females) in the ceftibuten group and in 89% of patients (94% of males, 85% of females) in the norfloxacin group. The relative frequency of eradication was 0.84 (p < 0.05; 95%, confidence interval 0.74-0.97). Adverse events were reported by 47% of the patients in the ceftibuten group and by 38% in the norfloxacin group. This difference was not significant, but diarrhoea or loose stools occurred more frequently in the ceftibuten group.

Topics: Acute Disease; Administration, Oral; Adult; Aged; Aged, 80 and over; Anti-Infective Agents; Ceftibuten; Cefuroxime; Cephalosporins; Double-Blind Method; Drug Therapy, Combination; Escherichia coli; Escherichia coli Infections; Female; Humans; Injections, Intravenous; Male; Middle Aged; Norfloxacin; Prospective Studies; Pyelonephritis; Recurrence; Treatment Outcome

The available oral third generation of cephalosporin, "ceftibuten" was used to substitute the intravenous drug after defervescence in acute pyelonephritis in children. This randomized controlled study compared the efficacy of an oral ceftibuten switch therapy with a ceftriaxone in both short-term and long-term outcomes. 36 99mTc-dimercaptosuccinic acid (DMSA) scan proved pyelonephritis patients were randomized into the study group, "ceftibuten" (N=18) and the control group, "ceftriaxone" (N=18). Ceftriaxone (75 mg/kg/day) was the initial antibiotic in both groups. After defervescence for 24-48 hours, oral ceftibuten (9 mg/kg/day) was substituted in the study group and continued for 10 days. The subject characteristics and laboratory data were not different between the two groups. The urine culture at D14 was sterilized in both groups. The incidence of renal scarring was 66.6 per cent and 61.1 per cent in the study group and the control group respectively. The rate of recurrent infection showed no statistical significance. The duration of hospitalization was shorter in the study group than in the control. In conclusion, oral ceftibuten switch therapy can be recommended as a safe and effective treatment for acute pyelonephritis in children. The use of oral therapy may result in a significant reduction of health care expenditure.

Topics: Acute Disease; Administration, Oral; Adolescent; Ceftibuten; Ceftriaxone; Cephalosporins; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Injections, Intravenous; Male; Prospective Studies; Pyelonephritis; Reference Values; Treatment Outcome

in recurrent acute otitis media (AOM) several alternative treatments are suggested, e.g. cephalosporins. Information about the optimal duration of treatment in recurrent AOM is sparse. The aim of the present study was to compare the efficacy of ceftibuten in 5 versus 10 days treatment in recurrent AOM in children.. this was a single-blind (doctor blinded), randomized, multicentre study with two parallel groups. Eleven investigators at six centres in the west of Sweden enrolled a total of 180 patients. Outpatients with a new clinical AOM within 1 month were randomized to 5 or 10 days treatment with ceftibuten, 9 mg/kg/day, as a single dose.. the mean age of the patients was 1.2 years (range 6 months-8 years). The patients had on average had three antibiotic treatments during the preceding 12 months. The recurrence rates in the 5- and 10-day groups were 21.4 and 4.5%, respectively, at first follow-up visit day 12 (P=0.001). The total recurrence rates between the two groups during the whole follow-up period of 40 days, 35 and 30%, respectively, did not differ significantly. The rate of recurrence did not correlate to nasopharyngeal findings of Streptococcus pneumoniae or Haemophilus influenzae. Pneumococci with decreased susceptibility to penicillin were found in 5% of all pneumococci, and beta-lactamase producing H. influenzae in 8%. Adverse events were reported less frequently in the 5- compared with the 10-day treatment group.. this study on young children with recurrent otitis media has shown no statistical difference between ceftibuten given once daily for 5 and 10 days as determined on day 40. The 10-day treatment was significantly better at early follow-up.

Topics: Acute Disease; Ceftibuten; Cephalosporins; Chi-Square Distribution; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Gram-Negative Bacteria; Gram-Positive Bacteria; Humans; Infant; Male; Microbial Sensitivity Tests; Otitis Media; Recurrence; Sweden; Treatment Outcome

The aim of this study was to determine the potential influence of variables such as the cell content in the fluid, and serum levels, on the concentrations of ceftibuten, cefixime and azithromycin in the middle ear fluid of patients suffering from acute otitis media.. This randomized, open study compared the penetration of ceftibuten (9 mg kg(-1) 18 patients), cefixime (8 mg kg(-1), 16 patients) and azithromycin (10 mg kg(-1) 16 patients) into the intracellular and extracellular compartments of middle ear fluid of 50 paediatric patients (aged 8-14 years) with acute otitis media. Middle ear fluid was extracted by tympanocentesis 4, 12 and 24 h after dosing and divided into two fractions: with cells (as collected) (C+) and cell-free (C-). Antibiotics were assayed in C+ and C- samples by h.p.l.c.. Ceftibuten achieved greater penetration into middle ear fluid than cefixime and azithromycin. Higher concentrations of ceftibuten (CTB) and cefixime (CFX) were found in the C- fraction (CTB: 4h 13.3+/-1.86; 12h 4.7+/-1.18; 24h 0.5+/-0.2. CFX: 4h 3.2+/-1.4; 12h 1.5+/-0.5; 24h>(0.1 mgl(-1)) than in the C+ fraction (CTB:4 h 8.4+/-4.3; 12 h 2.88+/-1.19; 24 h 0.3+/-0.27. CFX: 4 h 1.2+/-0.6; 12 h 0.8+/-0.2; 24 h>0.1 mg l(-1)) at the each time point, while the opposite was true for azithromycin (C-: 4 h 0.11+/-0.04; 12 h 0.12+/-0.08; 24 h 0.23+/-0.12. C+: 4 h 0.38+/-0.24; 12 h 0.9+/-0.03; 24 h 1.05+/-0.3 mg l(-1)).. This study demonstrates that the penetration of antibiotics into the middle ear fluid is influenced by its serum concentrations as well as by the cell content in the fluid. Ceftibuten achieved higher middle ear fluid concentrations than cefixime in C+ and C- fractions at all time points. Both ceftibuten and cefixime concentrations are negatively influenced by the cell content in the fluid. In contrast the concentration of azithromycin to the middle ear fluid is positively influenced by the cell content in the fluid.

Topics: Acute Disease; Administration, Oral; Adolescent; Anti-Bacterial Agents; Azithromycin; Cefixime; Cefotaxime; Ceftibuten; Cephalosporins; Child; Exudates and Transudates; Female; Humans; Male; Otitis Media with Effusion; Time Factors

A prospective randomized study was conducted at an infectious disease hospital in Thailand. Ceftibuten was compared with norfloxacin, both given orally for five days for treatment of acute gastroenteritis in children. One hundred and seventy cases were included in the study. Eighty-eight cases were treated with ceftibuten and eighty-two cases with norfloxacin. The baseline characteristics of the patients in both treatment groups were similar. The results showed that mean durations of diarrhea in the ceftibuten and norfloxacin groups were 2.48 days and 2.29 days, respectively, but there was no statistically significant difference between the two groups (p > 0.05). There were Salmonella spp and Shigella spp isolated in both treatment groups and all were susceptible to both antibiotics. The mean durations of Salmonella diarrhea in the ceftibuten and norfloxacin groups were 2.7 and 2.2 days, respectively, while those of Shigella diarrhea were 2.3 days and 2.0 days, respectively. There were no statistically significant differences in either comparison (p > 0.05). Neither complications nor clinical relapses were observed after both antibiotics' treatment.

Topics: Acute Disease; Anti-Infective Agents; Ceftibuten; Cephalosporins; Child; Child, Preschool; Diarrhea; Drug Resistance, Microbial; Dysentery, Bacillary; Female; Humans; Infant; Male; Norfloxacin; Prospective Studies; Salmonella Infections

The efficay and safety of short course ceftibuten (400 mg od for 5 days; n = 163) were compared with that of amoxycillin/clavulanate (AMX/CA) (250/125 mg tds for 10 days; n = 172) in a multicentre, single-blind, parallel-group trial in 335 adults with acute exacerbations of chronic bronchitis (AECB). Clinical response was equivalent, with cure or improvement in 134/145 (92.4%) ceftibuten-treated patients and 139/150 (92.7%) AMX/CA-treated patients (95% CI: -7.00%, +6.50%). The overall eradication rates were similar (ceftibuten 88.3%; AMX/CA 87.5%) and also the incidence of adverse events which occurred in 24/163 (14.7%) ceftibuten-treated and 27/172 (15.5%) AMX/CA-treated patients. Ceftibuten 400 mg od for 5 days is as effective and well tolerated as AMX/CA 250 mg tds for 10 days in the treatment of AECB.

Topics: Acute Disease; Adult; Amoxicillin; Bronchitis; Ceftibuten; Cephalosporins; Chronic Disease; Clavulanic Acid; Confidence Intervals; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Treatment Outcome

A group of 66 patients with acute inflammatory upper respiratory tract diseases were examined in the ENT Department of Poznań Medical Academy between November 1996 and November 1997. Specimens for bacteriological cultures were collected from the ear, nose and throat. The subjects were treated with ceftibuten. Clinical improvement was reported in all cases. In 44 patients, ceftibuten treatment eliminated pathogenic bacteria (as evidenced by microbiological analysis).

Topics: Acute Disease; Adolescent; Adult; Aged; Ceftibuten; Cephalosporins; Child; Child, Preschool; Humans; Middle Aged; Respiratory Tract Infections; Retrospective Studies

The penetration of ceftibuten, an extended-spectrum oral cephalosporin, into middle ear fluid (MEF) was evaluated in pediatric patients during a course of daily oral doses of 9 mg/kg of body weight for 10 days. Plasma and MEF collected at 2, 4, 6, or 12 h after at least 3 days of dosing were analyzed for ceftibuten by a high-pressure liquid chromatography method, and the data were used to calculate pharmacokinetic parameters. Plasma and MEF had almost identical maximum concentrations (Cmax) of ceftibuten (14 micrograms/ml). These Cmax values in MEF during acute otitis media were well in excess of the MIC for 90% of the isolates of each of four major pathogens in this disease. The time to Cmax was longer in MEF (4 h) than in plasma (2 h). Excellent penetration (71%) of ceftibuten into MEF was observed on the basis of the area under the curve ratio (MEF/plasma). These data clearly indicate that ceftibuten penetrated well into the MEF to yield clinically effective concentrations.

Topics: Acute Disease; Ceftibuten; Cephalosporins; Child, Preschool; Chromatography, High Pressure Liquid; Ear, Middle; Humans; Infant; Otitis Media

A randomized, controlled, single blind clinical trial was conducted in children with acute otitis media to evaluate the safety and efficacy of a 10-day course of therapy with ceftibuten 9 mg/kg taken as a single daily dose, up to a maximum daily dose of 400 mg, compared with cefaclor 40 mg/kg/day in three divided doses, up to a maximum of 1 g/day. Patients were evaluated any time from 1 to 3 days after completion of therapy (posttreatment follow-up). A total of 154 patients (106 ceftibuten, 48 cefaclor) were evaluable for efficacy. Clinical success as determined by resolution (cure) or improvement of signs and symptoms of infection were seen in 89 and 88% of patients treated with ceftibuten and cefaclor, respectively, at the posttreatment follow-up visit. At the extended follow-up visit (any time from 2 to 4 weeks after completion of therapy), clinical success was sustained in 88 and 82% of the ceftibuten-treated and cefaclor-treated patients, respectively. A total of 391 patients (264 ceftibuten, 127 cefaclor) were included in the safety analysis. Treatment-related adverse experiences occurred in 8% of ceftibuten-treated patients and 14% of cefaclor-treated patients. All were mild or moderate and the majority were gastrointestinal. There were no deaths or serious adverse events. The results of this study suggest that ceftibuten is an effective and well-tolerated alternative to other antibiotic therapies for the treatment of children with acute otitis media.

Topics: Acute Disease; Adolescent; Bacterial Infections; Cefaclor; Ceftibuten; Cephalosporins; Child; Child, Preschool; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Prospective Studies; Single-Blind Method; Treatment Outcome

The efficacy and safety of ceftibuten (9 mg/kg daily for 10 days) were compared with those of amoxicillin/clavulanate (Augmentin 40 mg/kg/day given every 8 hours for 10 days) in the empiric treatment of acute otitis media in children. This was a multicenter, investigator-blinded study with 1:1 randomization. Overall clinical response and signs and symptoms of otitis were collected prospectively pretreatment, 3 to 5 days during treatment, 1 to 3 days post-treatment and at 2- to 4-week follow-up. In addition to spontaneous reports of other adverse events, gastrointestinal adverse events were prospectively elicited at each visit. Two hundred ninety-six patients (146 ceftibuten and 150 amoxicillin/clavulanate) were treated with at least 1 dose of study medication. Compliance with dosing was assessable with weight of drug consumed in 127 patients in each treatment group. Five percent (6 of 127) of ceftibuten patients and 11% (14 of 127) of amoxicillin/clavulanate patients received < 80% of prescribed drug (P = 0.10) and were therefore not valid. Two hundred twenty-two patients (121 ceftibuten and 101 amoxicillin/clavulanate) received a minimum of 80% of prescribed medication and were compliant with the protocol. Ceftibuten and amoxicillin/clavulanate groups were comparable both for demographic variables and for baseline signs and symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftibuten; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media with Effusion; Patient Compliance; Treatment Outcome

The efficacy and safety of a once-daily oral regimen of 400 mg ceftibuten was compared with oral co-amoxiclav 500 mg three times daily in a multicentre, single-blind study. In patients with a bacteriologically confirmed infection, a successful clinical outcome was reported in 25 of 25 patients treated with ceftibuten and 10 of 10 patients treated with co-amoxiclav. In a further group of 88 patients, most of whom had been excluded from the primary efficacy evaluation because no pathogen was isolated pretreatment, overall successful clinical outcomes of 87% and 88% were reported for ceftibuten and co-amoxiclav, respectively. The duration of treatment and the time to resolution of the signs and symptoms of sinusitis were not significantly different in the two treatment groups. The incidence of adverse events was higher in the co-amoxiclav-treated patients (31% versus 15% in the ceftibuten group) as was the incidence of severe events (10% for co-amoxiclav-treated patients versus < 1% in the ceftibuten group). In summary, once-daily ceftibuten can be considered a safe and effective treatment for acute bacterial sinusitis.

Topics: Acute Disease; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Ceftibuten; Cephalosporins; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Single-Blind Method; Sinusitis

Topics: Acute Disease; Bacterial Infections; Ceftibuten; Cephalosporins; Chronic Disease; Clavulanic Acid; Drug Resistance, Multiple; Humans; Mometasone Furoate; Penicillanic Acid; Pregnadienediols; Sinusitis; Treatment Outcome

The aim of the study was to substantiate clinically and microbiologically administration of such oral cephalosporins as cefuroxime axetil and ceftibuten in acute sinusitis. The spectrum of causative agents of acute sinusitis was determined, most common pathogens were identified and their sensitivity to antibiotics was tested. The conclusion is made that cephalosporins of the II-III generation meet the requirements to antibacterial drugs for treatment of acute sinusitis.

Topics: Acute Disease; Adult; Ceftibuten; Cefuroxime; Cephalosporins; Drug Tolerance; Female; Humans; Male; Sinusitis; Treatment Outcome

Ceftibuten is a new oral cephalosporin with an unusual stability to beta-lactamases that can hydrolyze other extended-spectrum cephalosporins. Using the chinchilla animal model, we compared the efficacy of ceftibuten (n = 33) with that of saline (n = 34), ampicillin (n = 32), and cefixime (n = 31) for the treatment of acute otitis media caused by beta-lactamase-producing nontypeable Hemophilus influenzae. Ceftibuten was superior to ampicillin regarding the time necessary to sterilize the middle ear (p < .001) and eliminate effusion (p < .001). The mean days of therapy required for bacteriologic cure were 2.57 for ceftibuten, 2.95 for cefixime, 7.95 for ampicillin, and 8.16 for saline. At the conclusion of therapy, chinchillas treated with ceftibuten had a significantly lower prevalence of positive cultures and middle ear effusion than did animals treated with ampicillin. No significant differences were observed between ceftibuten and cefixime. The results of this randomized, investigator-blinded experiment warrant further consideration of ceftibuten as a second-line agent for acute otitis media caused by ampicillin-resistant H influenzae.

Topics: Acute Disease; Ampicillin; Animals; Anti-Bacterial Agents; Cefixime; Cefotaxime; Ceftibuten; Cephalosporins; Chinchilla; Haemophilus Infections; Haemophilus influenzae; Otitis Media; Random Allocation

There is concern that third-generation cephalosporins may not be effective in the treatment of acute otitis media due to Streptococcus pneumoniae. Using the chinchilla animal model, we compared two third-generation cephalosporins, cefixime (Suprax) and ceftibuten (investigational), with ampicillin and saline controls in an investigator-blinded, randomized trial. Whereas the saline controls performed worse than all other groups, no significant differences were detected among the three antibiotics regarding the time required to sterilize the middle ear cleft, or the prevalence of positive cultures after 10 days of therapy. The statistical power of the comparisons of cefixime and ceftibuten with ampicillin were 98% and 67%, respectively. The results of this in vivo animal study fail to support the contention that the two third-generation cephalosporins investigated are not effective in the treatment of pneumococcal acute otitis media. Caution is advised when extrapolating these results to the general clinical setting.

Topics: Acoustic Impedance Tests; Acute Disease; Ampicillin; Animals; Cefixime; Cefotaxime; Ceftibuten; Cephalosporins; Chinchilla; Drug Evaluation, Preclinical; Otitis Media with Effusion; Pneumococcal Infections

Clinical evaluation of ceftibuten (CETB, 7432-S) was performed in 20 patients with acute bronchitis. They were consisted of 10 males and 10 females aged from 20 to 80 years old. CETB was given orally in daily dose of 300 mg (18 cases) or 600 mg (2 cases) in three divided portions. The duration of administration was 3 to 14 days. Especially they were given for 7 days in 16 cases. A total of 11 strains comprising 4 strains of Staphylococcus aureus, 2 strains of beta-Streptococcus and 1 strain each of Streptococcus pneumoniae, Branhamella catarrhalis, Klebsiella oxytoca, Serratia marcescens, Acinetobacter lwoffii were identified from sputa before administration. All of the above bacteria were eradicated but, in 1 case, a strain of Streptococcus pyogenes appeared after the treatment (eradication ratio = 100%). The clinical efficacy rate was 100%: Responses were excellent in 3 cases and good in 17 cases. There was no side effect and no abnormal changes in laboratory test results. From the avobe results, it is concluded that CETB is effective, safe and useful new oral cephem on acute bronchitis.

Topics: Acute Disease; Administration, Oral; Adult; Aged; Aged, 80 and over; Bronchitis; Ceftibuten; Cephalosporins; Drug Evaluation; Female; Humans; Male; Middle Aged