Ciprofloxacin in the treatment of chronic bacterial prostatitis: a prospective, non-comparative multicentre clinical trial with long-term follow-up. The German Prostatitis Study Group.

The efficacy and safety of ciprofloxacin 500 mg bd for 28 days were assessed in 65 adult males with symptomatic bacterial prostatitis, from eight centres in Germany. Urine and prostatic secretions were obtained for culture. Clinical signs and symptoms were evaluated at 12-18 days during treatment, end of treatment (4-9 days post-treatment), and 1, 3, 6 and 9 months post-treatment. Safety was monitored during and at the end of treatment. E. coli was the most frequent pathogen causing infection (35/62) and Enterococcus faecalis the second most frequent (13/62). The combined bacteriological response by patient determined at return visits 4-9 days post and 1 month post-treatment, respectively, was eradication 48/54 (88.9%), persistence 3/54 (5.6%), eradication with recurrence 1/54 (1.9%) and eradication with reinfection 2/54 (3.7%). The clinical response at 1 month post-treatment was resolution 53/54 (98. 1%) and 1/54 (1.9%) failure. The rates for continued eradication in the extended follow-up were 32/39 (82.1%) after 3 months, 26/34 (76. 4%) after 6 months and 13/22 (59.1%) after 9 months. Nineteen patients experienced at least one adverse event. In two patients the trial was prematurely discontinued due to adverse events.

[1996 pathogen incidence and resistance status in peritonitis]. / Erregerhäufigkeit und Resistenzsituation bei Peritonitis 1996.

Severe intra-abdominal infection is associated with a high mortality rate. In addition to risk factors in the patients, the causal pathogens and the selection of appropriate therapeutic procedures play an essential part in the course of these conditions. In the majority of intra-abdominal infections mixed aerobic/anaerobic infections, mostly with some involvement of enterobacteria and also of enterococci and staphylococci can be demonstrated. In addition to surgical intervention a calculated antimicrobial initial treatment of intra-abdominal infections with an antibiotic with an adequate effect to combat the pathogen concerned can contribute to improving the patient's prognosis. A calculated antibiotic treatment can only be effectively and reliably carried through if the frequency of the pathogen and the resistance situation are known. Retrospective evaluations of data on the sensitivity and frequency of pathogens from a defined group of subjects allow conclusions on the epidemiological situation in a particular catchment area or in a medical sector and thus make it possible to calculate the appropriate therapy for infections. In 1996 a total of 2,779 bacterial isolates from the intra-abdominal infection sector were examined: 935 Enterobacteriaceae, 83 nonfermenters, 177 Staphylococcus spp., 211 Enterococcus spp., 39 Streptococcus spp., and 1334 different anaerobic bacteria. Fresh clinical isolates were available for all pathogens tested. The most frequent gram-negative pathogen was E. coli (60%) and the most frequent gram-positive pathogen, E. faecalis (44%); the most frequent anaerobic pathogen was B. fragilis (39%). Taurolodine had the lowest resistance rate against gram-negative and anaerobic pathogens. Teicoplanin had the highest activity against gram-positive pathogens.

A multinational European survey on the in-vitro activity of rufloxacin and other comparative antibiotics on respiratory and urinary bacterial pathogens.

The antibacterial activity of rufloxacin was confirmed against a large number of respiratory and urinary tract pathogens collected in five European countries. In terms of both MIC90 values and percentages of susceptible isolates found, this new quinolone showed useful in-vitro activity against Mycoplasma catarrhalis, Haemophilus influenzae and Klebsiella pneumoniae, with a large proportion of Staphylococcus aureus also covered, while, as expected Streptococcus pneumoniae and Streptococcus pyogenes were not included in its antibacterial spectrum. Rufloxacin was comparable with the other antibiotics against these pathogens with the exception of streptococci. Against these microorganisms, beta-lactams were the most active agents. Against the urinary pathogens the in-vitro activity of rufloxacin is similar to that of norfloxacin although this latter drug is more active in terms of MIC90 values and in percentages of strains inhibited. In many cases more isolates were susceptible to the remaining comparator agents than to rufloxacin. However, there were no significant differences between the numbers of microorganisms inhibited by the various drugs and rufloxacin. The findings of this survey do not seem to modify the general picture which emerged in previous studies and further confirms its useful spectrum in different geographic settings.

Double-blind, comparative study of rufloxacin once daily versus amoxicillin three times a day in treatment of outpatients with exacerbations of chronic bronchitis.

In a double-blind, randomized, multicenter study, the efficacy and safety of two dosage schedules of rufloxacin once daily were compared with those of amoxicillin three times a day in the treatment of 192 outpatients with exacerbations of chronic bronchitis. Rufloxacin was given as a single oral dose of 400 mg on day 1 and single daily doses of 200 mg on the subsequent 9 days (n = 64) or as 300 mg on day 1 and then 150 mg daily for 9 days (n = 63); amoxicillin was given as 500 mg orally three times a day for 10 days (n = 65). Clinical and bacteriological assessments were carried out before treatment, between study days 3 and 5, and at days 1 and 8 after treatment. Pretreatment cultures were positive for 139 patients, the most frequently isolated pathogens being Streptococcus pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae. Clinical success rates were comparable in the three groups (94, 95, and 98%, respectively), as were bacteriological success rates at the end of treatment (93, 95, and 91%, respectively) and at follow-up (88, 95, and 98%, respectively). The power to detect a significant 15% difference in cure rates was 74.9%. Follow-up bacteriological failures from pneumococcal infection were 18% in both rufloxacin groups combined and 5% in the amoxicillin group. The 200-mg dose regimen achieved average steady-state concentrations in plasma higher than did the 150-mg dose regimen (3.75 versus 2.72 micrograms/ml). Adverse events occurred in 11 and 13 patients, respectively, on rufloxacin and 8 on amoxicillin. This study shows that rufloxacin once daily ay be a possible option for the treatment of acute exacerbations of chronic bronchitis. The 200-mg daily oral dose preceeded by a loading dose of 400 mg displays a better pharmacokinetic profile than the lower dose.

Bactericidal effect of propolis in vitro against agents causing upper respiratory tract infections.

Propolis is a natural product of bees which exhibits an antimicrobial effect. In the study the existence of a bactericidal effect against several strains isolated from patients with infections in their upper respiratory tracts is demonstrated. In light of the use of propolis as a therapeutic agent in natural medicine for common colds and inflammatory processes this effect is discussed.

An assessment of temafloxacin in the treatment of chronic bacterial prostatitis.

Based on its in-vitro activity against the majority of organisms associated with bacterial prostatitis and its excellent penetration into prostatic tissue, prostatic secretions and seminal fluid, temafloxacin appears to be a suitable agent for the treatment of prostatic infections. The efficacy and safety of temafloxacin 400 mg bd for 28 days were assessed in 61 patients from ten centres in Germany with symptomatic bacterial prostatitis diagnosed by segmented localizing cultures. Urine and prostatic secretions were obtained for culture. Clinical signs and symptoms were evaluated at two weeks during treatment, and at 5 to 9 days and 26 to 30 days after treatment. Safety was monitored during and at the end of treatment. Escherichia coli and Enterococcus spp. were the most frequent pathogens. In 41 clinically and bacteriologically evaluable patients, 37 (90%) were successfully treated at 5 to 9 days; four of these patients did not return for follow-up at the final visit and the remaining patients (33) continued to be clinically cured or improved. Thirty-seven patients (90.2%) had eradication of pre-treatment pathogens at 5 to 9 days after treatment; three of these patients did not return for this final follow-up visit. There were six patients with persistent or recurrent pathogens isolated and six patients with reinfecting pathogens. Thus, 26 of 38 (68%) evaluable patients at visit 5 were free from infection (from either a pre-treatment pathogen or any subsequent new infecting pathogen) up to 26 to 30 days after treatment. One clinically evaluable but bacteriologically non-evaluable patient was classified as a therapeutic failure after nine days of treatment and was not included in the final assessment. Improvement in the severity of specific signs and symptoms was observed in greater than 90% of cases. Mild to moderate adverse events, mostly occurring during the first or second weeks of long-term therapy, were reported in 11.5% of patients. Temafloxacin 400 mg bd, for four weeks was very effective and well tolerated by the majority of patients with documented bacterial prostatitis.

An open multicentre study on the efficacy and safety of rufloxacin in patients with chronic bacterial prostatitis.

In an open study, 27 patients with chronic bacterial prostatitis were treated for four weeks with rufloxacin. They received 400 mg on the first day, and then 200 mg once daily. The patients were studied for up to one month after completion of therapy. One patient was lost to follow-up, but was included in the safety analysis. One patient did not meet all the inclusion criteria (WBC less than 10/HPF in the prostatic fluid sample) and was evaluated separately (cure). One month after treatment, clinical success (cure and improvement) was obtained in 23 of 25 patients (92%) and bacteriological eradication was achieved in 19 of 24 patients (79%). The only adverse event possibly related to the study drug was a case of transient mild tiredness and nervousness. Rufloxacin did not accumulate in plasma during therapy. Hence, a single daily dose of rufloxacin 200 mg appears to be a safe treatment for chronic bacterial prostatitis.

Rufloxacin once daily in acute exacerbations of chronic bronchitis.

In this open study the efficacy and tolerability of rufloxacin in a single dose of 400 mg the first day and 200 mg the nine consecutive days was studied in 26 patients with an acute exacerbation of chronic bronchitis. Twenty-two patients were evaluable for efficacy. Four patients stopped treatment prematurely after five days because of clinical cure. At the enrollment visit a pathogen was isolated in the sputum sample in 19 of 22 evaluable patients. The predominant pathogens were Streptococcus pneumoniae and Moraxella catarrhalis. In 17 of these 19 bacteriologically evaluable patients the initial infecting organism was eradicated from specimens obtained within 48 hours after the end of therapy. There was one case of persistent infection caused by S. pneumoniae (MIC 4 mg/l), one patient had a superinfection with Serratia marcescens (MIC 1 mg/l) susceptible to rufloxacin and therapy was stopped after five days due to clinical failure. One week after the end of therapy, 15 patients remained free from infection whilst one patient experienced reinfection with Klebsiella pneumoniae (MIC 0.5 mg/l). Clinical cure or improvement was observed in 21 of 22 patients. Mild adverse events were reported by two of 26 enrolled patients. In one patient, complaining of headache and dizziness, the adverse events were considered possibly study drug related. No abnormal laboratory findings were reported. Nadir plasma levels of rufloxacin were measured and no accumulation in plasma was observed during treatment. A ten day course of an oral single dose of rufloxacin proved efficacious and was well tolerated in patients with an acute exacerbation of chronic bronchitis.(ABSTRACT TRUNCATED AT 250 WORDS)

In vitro activity of the combination trimethoprim plus sulfamethoxazole compared with that of other chemotherapeutic agents.

For many years now, the combination trimethoprim plus sulfamethoxazole (active ingredients of Bactrim) has proved to be an effective chemotherapeutic agent with a broad spectrum of antibacterial activity against both gram-positive and gram-negative organisms, including beta-hemolytic streptococci, staphylococci, pneumococci, Haemophilus influenza, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella, Enterobacter and Citrobacter. In this comparative study, the antibacterial activity of the combination against 2,229 gram-negative and 1,338 gram-positive strains encountered in domiciliary practice was tested and compared with that of other commonly used antimicrobials. Minimum inhibitory concentrations (MICs) were determined in microtitre plates using serial dilutions. With regard to the gram-negative strains, trimethoprim + sulfamethoxazole, with an MIC90 of less than 2 mg/l for most isolates, was the most active substance apart from norfloxacin. The combination also had a powerful inhibitory effect on gram-positive strains, the MIC90 being between 2 and 4 mg/l for all strains except Staphylococcus epidermidis.

Sensitivity of clinical isolates from German hospitals to amoxicillin/clavulanic acid (Augmentin) compared with other antibiotics.

17,244 pathogens isolated from clinical specimens of 24 hospitals in the Moers area (North-Rhine Westphalia, FRG) were tested in regard to their susceptibility to Augmentin (amoxicillin and clavulanic acid). For this purpose, minimal inhibitory concentrations were determined by use of microbroth dilution technique. 80% of Gram-negative, 98% of Gram-positive and 97% of anaerobic isolates were susceptible to Augmentin (breakpoint 4 mg/l amoxicillin in the presence of 2.5 mg/l clavulanic acid). In a second part of the study the susceptibility to Augmentin of 4.137 Gram-negative and 10.958 Gram-positive pathogens was compared to their sensitivity against benzylpenicillin, flucloxacillin, mezlocillin, erythromycin, clindamycin, fusidic acid, ampicillin, cefaclor and doxycyclin.

Antibacterial effect of imipenem in vitro against important aerobic and anaerobic strains isolated from clinical specimens.

Imipenem is a thienamycin antibiotic of the first generation with broad antibacterial activity. It covers all gram-positive organisms (including Streptococcus faecalis) and gram-negative bacteria (including Pseudomonas aeruginosa and Serratia spp.) as well as Bacteroides fragilis and other Bacteroides species. In this comparative study the antimicrobic effect against 1020 gram-negative, 927 gram-positive and 352 anaerobic strains from fresh clinical isolates was tested and compared with that of other frequently used antibiotics. The minimum inhibitory concentrations (MIC) were determined by means of a serial dilution test with micro standard plates. Within the group of gram-negative strains, imipenem was the most active antibiotic with a MIC90 of less than or equal to 0.25 mg/l for most isolates. Imipenem shows a broad spectrum of activity against gram-negative pathogenic bacteria including Escherichia coli, Klebsiella spp., Proteus spp, Enterobacter spp., Citrobacter spp. and Serratia spp., and also covers resistant strains of Pseudomonas aeruginosa, Acinetobacter spp. and Alcaligenes faecalis. Imipenem also shows high inhibiting activity against gram-positive strains and anaerobic pathogens.

Comparative in vitro activity of ciprofloxacin against aerobic and anaerobic bacteria from clinical isolates.

1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-piperazin-1- ylquinoline-3-carboxylic acid (ciprofloxacin, Bay o 9867, Ciprobay) is a broad spectrum antibiotic of the 4-quinolone group. It possesses a bactericidal effect attributable to the property of DNA-gyrase inhibition. The antimicrobial action comprises all grampositive strains (including Streptococcus faecalis) and gramnegative strains (including Pseudomonas aeruginosa and Serratia spp.), as well as Bacteroides fragilis and other Bacteroides species. In this comparative study the antimicrobial effect of ciprofloxacin was tested against 665 gramnegative, 412 grampositive and 274 anaerobic strains from fresh clinical isolates and compared with that of other frequently used antibiotics. The minimum inhibitory concentrations (MIC) were determined by means of a serial dilution test with micro standard plates. Within the group of gramnegative strains, ciprofloxacin was the most active antibiotic with an MIC90 of 0.12 mg/l to 0.5 mg/l for most isolates. Ciprofloxacin shows a broad spectrum of activity against gramnegative pathogenic bacteria including Escherichia coli, Klebsiella spp., Citrobacter spp., Enterobacter spp., Serratia spp. and Acinetobacter spp., and also covers resistant strains of Pseudomonas aeruginosa and Alcaligenes faecalis. Ciprofloxacin also shows a high inhibiting activity against grampositive strains (Staphylococci, Enterococci) and anaerobic pathogens.

[Comparative in vitro study of the antimicrobial activity of ceftazidime against clinical isolates]. / Vergleichende In vitro-Studie zur antimikrobiellen Aktivität von Ceftazidim gegen klinische Isolate.

The antimicrobial activity of ceftazidime was tested against 1482 gram-negative and 1216 gram-positive strains isolated from fresh clinical specimens and compared with generally used antibiotics including other third generation cephalosporins and broad spectrum penicillins. Minimal inhibitory concentrations were determined in a broth dilution test on microtiter plates. In the group of the gram-negative bacteria ceftazidime was the most active of the antimicrobial agents tested with an MIC of 0.5 mg/l (MIC90) for most of the isolates. Ceftazidime exhibited a broad spectrum of activity against gram-negative pathogenic bacteria including Enterobacteriaceae (Escherichia coli, Klebsiella spp., Proteus spp. Enterobacter spp., Citrobacter spp., Serratia spp.) including frequently resistant strains of Pseudomonas aeruginosa, Acinetobacter spp. and Alcaligenes faecalis. The activity against P. aeruginosa is the most remarkable property of the agent. Ceftazidime is less effective against gram-positive compared to gram-negative bacteria. No inhibitory action can be observed against Streptococcus faecalis.

A survey of temocillin sensitivity of strains resistant to newer beta-lactam antibiotics.

The susceptibility of a total of 2014 Gram-negative clinical isolates (except Pseudomonas aeruginosa) to a number of antibiotics, including temocillin, was investigated in 2 geographically distinct areas. Overall, more strains were sensitive to temocillin than to mezlocillin, piperacillin, amoxycillin plus clavulanic acid, cefotaxime, cephazolin, latamoxef (moxalactam), cefoxitin, or netilmicin. Susceptibility to temocillin of multiple-resistant strains was studied.

In-vitro activity of augmentin against clinically important gram-positive and gram-negative bacteria in comparison with other antibiotics.

The susceptibility to Augmentin of a total of 1,417 bacterial isolates was investigated. Augmentin is a new formulation of the broad-spectrum beta-lactam-antibiotic amoxicillin together with the beta-lactamase-inhibitor clavulanic acid. It was demonstrated that 88% of all isolates tested were sensitive to Augmentin, 9% were resistant. 88% of all Pseudomonas aeruginosa strains fell in the "resistant" category. Only 1/71 anaerobes and 15/286 staphylococci were classified as resistant to Augmentin.