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PubMed1987

Septicemia in a university pediatric hospital: a five-year analysis of the bacterial and fungal isolates and outcome of the infections.

A 5-year analysis comprising all positive blood culture isolates from a 222-bed university pediatric hospital in Helsinki revealed 369 bacteremic but only 8 fungemic cases. Haemophilus influenzae and Staphylococcus aureus, 19% of the total material each, were the most common pathogens isolated, followed by S. epidermidis (11%), Escherichia coli (8%), pneumococci (8%), and group B beta-hemolytic streptococci (6%). Remarkable differences in distribution of the pathogens were observed in different hospital units. However, 5 most common microorganisms covered 62-86% of the spectrum in each unit. Two bacteria, H. influenzae in the unit for infectious diseases and S. aureus in the hematology-oncology unit were significantly (p less than 0.001 or less than 0.01, respectively) more common than any other organism in those units. The average case fatality rate was 14% with a range from 1.5% to 40%, depending upon the causative agent isolated. Also, the mortality was much higher in neonates than in other age groups. We conclude that by monitoring the blood isolates separately in each unit one can find remarkable differences in the same hospital. On the other hand, characteristics of an individual hospital may vary significantly from those described in textbooks. These characteristics should be recognized and taken into account in the antimicrobial policy.

Bacteria↗
PubMedDate not supplied

In vitro activity of lomefloxacin (SC 47111 or NY-198), a new quinolone antimicrobial, against clinical isolates of common pathogens.

The lomefloxacin antibacterial activity was assessed against 442 clinical isolates of common bacterial pathogens and compared to the previously studied activity of ciprofloxacin, imipenem, norfloxacin, and other commonly used antibacterials. Lomefloxacin showed activity against the species of Enterobacteriaceae tested at a concentration equal to or below that of the most commonly used agents. Activity was lower against Pseudomonas species as well as most Gram-positive isolates tested with the exception of Staphylococcus aureus. Streptococcal strains were least susceptible. The results of this study support previous reports of excellent antimicrobial activity for lomefloxacin, especially against Gram-negative organisms.

4-Quinolones↗
PubMed1993

Prospective multicentric study of the etiology of 1051 bacteremic episodes in 782 cancer patients. CEMIC (French-Belgian Study Club of Infectious Diseases in Cancer).

A total of 1051 bacteremic episodes (782 patients) were prospectively recorded in 10 cancer centers (9 French, 1 Belgian), with: patient's age (mean 53, range 1-89 years), underlying cancer, neutropenia (< 1000 neutrophils/microliters; 233), signs and symptoms, type of i.v. line (percutaneous central: 534; peripheral: 228; central implanted: 304), treatment, blood culture system, number of positive blood culture bottles/total obtained, time to growth. Of all episodes, 23.2% occurred within 48 h of admission. The patients were receiving systemic antibiotics at sampling (on AB) in 34.6% of cases. The 1147 pathogens isolated (86 polymicrobial) were: E. coli (10.7%), Klebsiella-Enterobacter-Serratia (6.1%), other enterobacteriaceae (2.2%), Pseudomonas aeruginosa (4.8%), other nonfermenters (4.7%), coagulase-negative staphylococci (CNS, 40.8%), Staphylococcus aureus (9.9%), streptococci (5.4%), enterococci (2.2%), anaerobes (3.4%), yeasts (3.5%), and other bacteria (6.9%). The CDC (Centers for Disease Control) criteria (1988) were used to assess significance: group 1: pathogenic species (616 episodes; 59%); group 2: clinical signs and isolation of a "contaminant" species (47; 4.5%); group 3: as in group 2 with an i.v. line and empiric antibiotic treatment (181 episodes including 176 CNS; 17%); group 4: non-significant (207 episodes including 203 CNS; 20%). Groups 1-3, in which the episodes were considered to be significant (844 episodes; 80%) were compared with non-significant episodes (Fisher). Significant differences (P < or = 0.05) were seen in time to growth (median growth within 24 h vs 48 h), fever (86% vs 54%), chills (40% vs 3%), hypotension (10% vs 2%), septic shock (9% vs 1%), polymicrobial etiology (10% vs 0.5%), and initiation of empiric antibiotic treatment (71% vs 4%). Bacteremic episodes of CDC groups 1, 3 and 4 were further studied in episodes with a single isolate as a doubtful clinical significance (482 episodes) and episodes with > or = 2 bottles positive of probable clinical significance (569 episodes; 54%). In group 1 (218 doubtful, 398 probably significant episodes) significant differences were seen in chills (36% vs 52%), shock (7% vs 13%), polymicrobial (8% vs 17%), initiation of empiric antibiotic treatment (60% vs 72%); in group 3 (87 doubtful, 94 probably significant) in time to growth delay; in group 4 (177 doubtful, 30 probably significant) in proportion with implanted catheter (26% vs 52%), fever (62% vs 10%), and time to growth. This study confirms the predominant role of Gram-positive cocci in bacteremia occurring in cancer patients.

Adolescent↗
PubMed1993

The spectrum of Aeromonas-associated diarrhea in tropical Queensland, Australia.

During a twelve-month period (1 July 91-30 June 92), feces from 912 persons from the Townsville region in the dry tropics of Queensland, Australia were evaluated by culture and 45 (4.9%) immunocompetent patients were found to be carrying Aeromonas in their stools. All patients were index cases and no secondary cases from household or close contact of index cases were identified. Eight patients (9.3%) were from Palm Island, an Aboriginal community, and 37 (4.5%) were from the essentially Caucasian population of Townsville. This is a significant difference in incidence of cases between the two population groups. Infection occurred mainly in two age groups: the under five-year-old (27 cases) and the over 25-year-old age group (17 cases). Except for one patient, all cases of Palm Island Aborigines were children less than five years of age, and 13 of these infants (48%) were less than 1 year old, but none were neonates. Of the 37 Townsville patients, 20 cases (54%) were in the under five-year-old group. Signs and symptoms of Aeromonas-associated diarrhea in patients where Aeromonas was the sole pathogen isolated were diarrhea sometimes with vomiting, absence of fever and of fecal leukocytes and blood in the stools. No cases of Aeromonas-associated diarrhea with dysentery were encountered. After rotavirus (12.3%), Aeromonas was the second most common enteric pathogen detected, but was only marginally more common than Giardia and Salmonella. Of the aeromonad isolations, 50% were Aeromonas hydrophila, 22% were A. sobria, and 28% were A. caviae.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1998

Susceptibility of European respiratory tract isolates to trovafloxacin, ciprofloxacin, clarithromycin, azithromycin and ampicillin.

As part of the Artemis project, 11500 isolates (3000 from patients with respiratory tract infections) were collected throughout six European countries between 1994 and 1996. Twenty-seven hospitals or laboratories participated in this first phase of the study. The activities of three classes of antimicrobial agents (fluoroquinolones, beta-lactam agents, macrolides) are presented for the six most frequently isolated pathogens (Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Klebsiella pneumoniae). Overall, trovafloxacin and ciprofloxacin activities were similar for Haemophilus influenzae, Moraxella catarrhalis and Klebsiella pneumoniae isolates. Of the Streptococcus pneumoniae isolates, 6% were resistant to penicillin. Trovafloxacin had the highest activity against the Streptococcus pneumoniae isolates, with a minimum inhibitory concentration of 0.25 mg/l for 90% of isolates (MIC90); all strains tested were susceptible to trovafloxacin. The MIC90 of ciprofloxacin for Streptococcus pneumoniae was 3 mg/l, and overall 52% of the strains were susceptible; 9% were resistant. Azithromycin and clarithromycin exhibited similar activity against all collected pathogens, except Haemophilus influenzae. All strains of Haemophilus influenzae were susceptible to azithromycin compared with 79% for clarithromycin, with respective MIC90s of 2 and 16 mg/l. The data presented demonstrate differences in the susceptibility patterns of six major respiratory tract pathogens in Europe.

Ampicillin↗
PubMed1976

Pathogenicity of field isolants of hemagglutinating encephalomyelitis virus for neonatal pigs.

The pathogenicity of hemagglutinating encephalomyelitis virus isolated from the brain of each of 5 pigs with clinical signs and microscopic lesions of encephalomyelitis (1 pig from each of 5 naturally infected herbs) was tested under experimental conditions. Each isolant was administered intranasally to 5 neonatal pigs. Clinically affected pigs developed either an acute or chronic form of illness, commencing 4 to 8 days after exposure. Listless, inappetence, and vomiting were clinical signs common to both forms. Additional signs of the acute form were paddling, muscle tremors, and hyperesthesia. Additional signs of the chronic form were loss of condition and either loss of weight or failure to gain weight at a rate similar to nonaffected littermates.

Animals↗
PubMed1990

[Epidemiologic study of pathogens causing nosocomial infections].

Nosocomial infection is a global problem. It significantly adds to the expected duration of hospitalization resulting with an increased economic burden and represents a leading cause of death. The characteristics of nosocomial infection vary from country to country and also changes with time. In order to understand the pathogens causing nosocomial infection in the large teaching hospital in Taiwan, we collected and analysed the surveillence data of nosocomial infection at the National Taiwan University Hospital from 1981 to 1989. We found that the nosocomial infection rate had been around 4-5% annually since 1981 till 1989. As ranked according to the site of infection, surgical wound infections were the most common, followed by the urinary tract, respiratory tract, and blood stream infections. However, the incidence of surgical wound infections had decreased gradually. About one third of nosocomial infections were caused by multiple microorganisms. The most frequently isolated pathogen has changed from Escherichia coli in early years to Pseudomonas aeruginosa in the most recent years. Gram-negative aerobic bacteria has been the major pathogens resulting in nosocomial infections for the past 9 years, accounting for 55-66%. In contrast, fungi have increased rapidly from 1.8% of total isolates in 1981 to 7.7% in 1989. Gram-positive cocci have also increased in recent years. The leading pathogen by infection site was P. aeruginosa in surgical wound infections, E. coli in urinary tract infections, and P. aeruginosa in respiratory tract infections. In earlier years E. coli was the major isolate in bacteremic cases, but glucose non-fermenters, including P. aeruginosa, Acinetobacter calcoaceticus and others, plus Enterobacter species-emerged as the major pathogens of recent years.(ABSTRACT TRUNCATED AT 250 WORDS)

Cross Infection↗
PubMed1992

In vitro and in vivo effect of antibiotics on catheters colonized by staphylococci.

An in vitro model was used to study whether and how catheter infections can be cured. Silastic catheters were "infected" with Staphylococcus aureus ATCC 25923 and Staphylococcus epidermidis KH11 and V2; these "infections" were then treated with 24, 48 and 96 h continuous infusions of various antimicrobial agents administered both as monotherapy and in combination. The Staphylococcus aureus strain was considerably more difficult to eliminate from catheters than were the Staphylococcus epidermidis strains. This experience gained in the laboratory was then applied in vivo to 16 episodes of catheter sepsis in seven children. Treatment for at least six days with imipenem/cilastatin combined with fosfomycin or an aminoglycoside successfully eliminated the pathogens isolated from 11 of the 16 episodes of infection. The broad-spectrum combination was chosen because it could not be assumed that individual pathogens would be sensitive to a single substance. Nine of the infected catheters could be retained in the patients. This experience suggests that it may be possible to successfully eliminate the colonization of central venous catheters by coagulase-negative staphylococci using the antimicrobial agents employed here.

Anti-Bacterial Agents↗
PubMed2002

A comparison of cefditoren pivoxil and amoxicillin/ clavulanate in the treatment of community-acquired pneumonia: a multicenter, prospective, randomized, investigator-blinded, parallel-group study.

BACKGROUND: Cefditoren pivoxil is a broad-spectrum cephalosporin that is approved for the treatment of pharyngitis, acute exacerbations of chronic bronchitis, and skin and skin-structure infections. OBJECTIVE: This study was conducted to examine the efficacy and tolerability of cefditoren in the treatment of community-acquired pneumonia (CAP). Amoxicillin/clavulanate was chosen as a comparator because of its established efficacy and general acceptance as a standard of care in CAP. METHODS: This multicenter, prospective, randomized, investigator-blinded, parallel-group trial compared oral cefditoren 200 and 400 mg BID with oral amoxicillin/clavulanate 875/125 mg BID for 14 days in adult outpatients with CAP. RESULTS: Eight hundred two patients (404 men, 398 women; mean age, 50 years; age range, 12-93 years) with CAP were enrolled. Comparable clinical cure rates were observed among evaluable patients in all treatment groups at both the posttreatment and follow-up visits: 88.0% (125/142) for cefditoren 200 mg, 89.9% (143/159) for cefditoren 400 mg, and 90.3% (130/144) for amoxicillin/clavulanate at the posttreatment visit, and 86.5% (128/148), 86.8% (138/159), and 87.8% (129/147) for the respective groups at the follow-up visit. Of 82 Streptococcus pneumoniae strains isolated before treatment, 22 (26.8%) had reduced susceptibility to penicillin, 12 (14.6%) of them penicillin resistant. Overall eradication rates at the posttreatment visit for pathogens isolated from microbiologically evaluable patients were 84.0%, 88.6%, and 82.6% for cefditoren 200 mg, cefditoren 400 mg, and amoxicillin/clavulanate, respectively. In the respective treatment groups, 80.6%, 88.6%, and 88.0% of Haemophilus influenzae strains and 95.0%, 96.2%, and 89.5% of S pneumoniae strains were eradicated. The rates of resolution of or improvement in clinical signs and symptoms were comparable between treatment groups. The treatment regimens were well tolerated, with 4.9%, 3.0%, and 5.2% of patients in the respective treatment groups requiring discontinuation of study drug due to an adverse event. CONCLUSIONS: In this study in adult outpatients with CAP, both doses of cefditoren demonstrated equivalence to amoxicillin/clavulanate based on rates of clinical and microbiologic cure. All 3 regimens were effective in resolving or improving the clinical signs and symptoms of CAP. Both cefditoren and amoxicillin/ clavulanate were well tolerated.

Adolescent↗
PubMed1980

Epidemiology of infection by nontuberculous Mycobacteria. III. Isolation of potentially pathogenic mycobacteria from aerosols.

Nontuberculous mycobacteria (21 isolates), biochemically similar to those that are recovered from humans, were recovered from rainwater and from natural river waters and their aerosols in the area of Richmond, Virginia. Field experiments have confirmed the existence of a natural mechanism for the transfer of significant numbers of mycobacteria from water to air. These findings support the hypothesis that aerosolization of potentially pathogenic mycobacteria from waters of the southeastern United States may be a major pathway for human infection.

Aerosols↗
PubMed1995

Persistent acute otitis media: I. Causative pathogens.

In this prospective study tympanocentesis was performed to determine the pathogens isolated from middle ear fluid of 200 ears in 137 children with acute otitis media (AOM) which had not responded after one or two empiric antimicrobial treatment courses (termed persistent AOM). For comparison tympanocentesis from 154 ears in 111 children with AOM not previously treated are described. Patients were enrolled from October, 1989, until September, 1992. In the persistent AOM group amoxicillin and trimethoprim/sulfamethoxazole were the most frequently used antimicrobials before tympanocentesis. Middle ear aspirates produced no pathogenic bacterial growth in 49% of persistent AOM patients, Streptococcus pneumoniae in 24%, Haemophilus influenzae in 7%, Branhamella catarrhalis in 7%, Streptococcus pyogenes in 6%, Staphylococcus aureus in 5% and two pathogens in 3%. Two (18%) of 11 S. pneumoniae isolates tested were penicillin-resistant; 1 was intermediate and 1 was highly resistant. Ten (83%) of 12 H. influenzae and all of 11 B. catarrhalis AOM isolates produced beta-lactamase. In comparison previously untreated AOM patients produced no bacterial growth from tympanocentesis in 30%, S. pneumoniae in 36% (8% penicillin-resistant), H. influenaze in 13% (44% beta-lactamase-producing) and B. catarrhalis in 11% (85% beta-lactamase producing). AOM which is persistent after initial empiric antimicrobial therapy may be caused by middle ear inflammation after bacteria are killed or involve penicillin-resistant S. pneumoniae, beta-lactamase-producing H. influenzae or B. catarrhalis more commonly than occurs in AOM which has not been recently treated.

Acute Disease↗
PubMed2005

Are ducks contributing to the endemicity of highly pathogenic H5N1 influenza virus in Asia?

Wild waterfowl are the natural reservoir of all influenza A viruses, and these viruses are usually nonpathogenic in these birds. However, since late 2002, H5N1 outbreaks in Asia have resulted in mortality among waterfowl in recreational parks, domestic flocks, and wild migratory birds. The evolutionary stasis between influenza virus and its natural host may have been disrupted, prompting us to ask whether waterfowl are resistant to H5N1 influenza virus disease and whether they can still act as a reservoir for these viruses. To better understand the biology of H5N1 viruses in ducks and attempt to answer this question, we inoculated juvenile mallards with 23 different H5N1 influenza viruses isolated in Asia between 2003 and 2004. All virus isolates replicated efficiently in inoculated ducks, and 22 were transmitted to susceptible contacts. Viruses replicated to higher levels in the trachea than in the cloaca of both inoculated and contact birds, suggesting that the digestive tract is not the main site of H5N1 influenza virus replication in ducks and that the fecal-oral route may no longer be the main transmission path. The virus isolates' pathogenicities varied from completely nonpathogenic to highly lethal and were positively correlated with tracheal virus titers. Nevertheless, the eight virus isolates that were nonpathogenic in ducks replicated and transmitted efficiently to naïve contacts, suggesting that highly pathogenic H5N1 viruses causing minimal signs of disease in ducks can propagate silently and efficiently among domestic and wild ducks in Asia and that they represent a serious threat to human and veterinary public health.

Animals↗
PubMed2002

[Retrospective microbiologic evaluation of vaginal cultures].

Vaginal culture is one of the most difficult cultures to be evaluated in clinical microbiology practice. The necessity of some expensive and complicated processes for diagnosis of some specific agents, age related variability of normal vaginal flora and failure caused by temporary presence of some pathogens in normal flora can be listed among the probable causes of that problem. In this study 8050 vaginal cultures performed in our hospital laboratories between 1 March 1999-15 September 2001 were evaluated retrospectively. It was shown that the most frequently isolated pathogens were yeasts belonging to the Candida genus (26.8%). The second most frequent pathogen (13.8%) was Gardnerella vaginalis which was an indicator of bacterial vaginosis. The rate of isolation of Trichomonas vaginalis was 2.2%. Group B streptococcus (GBS) was isolated in 2.0% of the total cultures. Some nonspecific bacteria, mainly Gram negative bacilli, were noted as colonizing agents (6.5%).

Adolescent↗
PubMedDate not supplied

Etiology of acute respiratory infections in children in tropical southern India.

Nasopharyngeal secretions and throat-swab specimens from 809 children less than 6 years old with acute respiratory infection were examined by culture and indirect immunofluorescence for the presence of virus or viral antigen. Blood was cultured for the presence of bacteria in selected cases of lower respiratory infection (LRI); pleural fluid also was cultured in cases of empyema. Viruses were detected in 163 (49%) of 331 children with LRI. Respiratory syncytial virus (RSV) was the commonest agent isolated (106 children). Other viruses isolated included parainfluenza viruses (36 children), adenoviruses (12), and influenza viruses (five). Outbreaks of infection due to RSV occurred during August through October. Pneumonia was the commonest LRI encountered (178 children). Among children with pneumonia, viruses were detected in 65 (37%) of 178 children, and bacteria were isolated from 27 (18%) of the 147 children for whom blood cultures were done. Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus were the common bacterial pathogens isolated. In cases of empyema and pyopneumothorax, S. aureus was the commonest organism isolated. There were 116 children with bronchiolitis, 83 (72%) of whom had viral infections; the majority of these children (81%) had RSV infection. Croup was uncommon (eight cases) and was caused mainly by parainfluenza viruses.

Acute Disease↗
PubMed1991

Comparative kinetics and efficacy of amikacin administered once or twice daily in the treatment of systemic gram-negative infections.

In an open randomized study the safety, efficacy and kinetics of a twice-daily amikacin (7.5 mg/kg bd) regimen (group A) was compared with a once-daily dosage (15 mg/kg) schedule (group B). Thirty patients were enrolled in each group. They were suffering from urinary tract infections (37), respiratory tract infections (17), soft-tissue infections (3), exacerbation of chronic prostatitis (1), acute cholangitis (1) and abdominal abscess (1). Aggravating factors were present in 77% and 60% of the groups respectively. The pathogens isolated included strains of various Enterobacteriaceae (53) and Pseudomonas aeruginosa (10) In 76.7 vs 97% (P less than 0.05) the clinical result was satisfactory with pathogen eradication in 80 vs 86.7%. However, there were proportionately more patients in the 7.5 mg/kg bd regimen with respiratory tract infection (40 vs 13%) and fewer patients with urinary tract infections (40 vs 80%). Mild and transient nephrotoxicity and ototoxicity was observed in five and three patients respectively. More patients in group B had amikacin trough concentrations less than or equal to 5 mg/l and peak levels greater than 40 mg/l (P less than 0.001) as well as serum bactericidal titres greater than or equal to 1:16 (P less than 0.05) without significant serum amikacin accumulation over time. It is concluded that amikacin administered once daily is well tolerated and provides better serum bactericidal activity than the twice-daily regimen.

Adult↗
PubMed1989

[Resistance of Shigella to antibiotics].

Antibiotic sensitivity of 104 Shigella clinical strains and 104 Escherichia coli strains isolated from patients with acute dysentery not treated with antibiotics in 1986-1987 was studied. It was shown that 100 per cent of the dysentery pathogens and colon bacilli were antibiotic resistant. Strains resistant simultaneously to chloramphenicol, ampicillin, streptomycin, tetracycline, monomycin and kanamycin were the most frequent among the dysentery pathogens. Colon bacilli and dysentery pathogens isolated from the same patient had specific sets of antibiotic resistance markers. Pathogenetic therapy of dysentery and exclusion of antibiotic use for several years did not result in lower numbers of Shigella antibiotic resistant strains.

Acute Disease↗
PubMed1993

Ofloxacin treatment of difficult infections of the skin and skin structure.

We report an open evaluation of ofloxacin therapy, 400 mg every twelve hours (parenterally followed by oral treatment) in hospitalized subjects with infections of the skin and skin structure that were recalcitrant. There were 105 evaluable subjects with an average age of fifty-five years, thirty-two (30 percent) of whom had diabetes mellitus, and in sixty-one (58 percent), a regimen of parenteral antibiotics (typically combinations involving aminoglycosides) had recently failed. There were 115 pathogens isolated; the most common were Enterobacteriaceae (fifty-five), Staphylococcus aureus (thirty), coagulase-negative Staphylococcus (ten), and Pseudomonas aeruginosa (ten). Overall, 103 (90 percent) pathogens were eradicated by therapy, and twelve (10 percent) persisted, including four coagulase-negative Staphylococcus which emerged as resistant during therapy. For thirty-five (33 percent) subjects, colonization or superinfection was documented; seven of these organisms (five Enterococcus, one S. aureus, and one P. aeruginosa) were resistant to treatment with ofloxacin. Clinical response was rated as cure in seventy (67 percent) subjects, improvement in twenty-one (20 percent) subjects, and failure in fourteen (13 percent). Failures were accompanied by persistence of the original pathogen (eight), persistent or resistant superinfection (six), or both (one). Adverse effects were infrequent, mild, and self-limiting. There was one death during the study, attributed to septic shock after postoperative abdominal leak, and not related to ofloxacin therapy. Intravenous/oral ofloxacin is effective and safe for the treatment of many difficult infections of the skin and skin structure, including those in diabetic subjects and in patients in whom previous parenteral therapy may have failed.

Abscess↗
PubMed1995

Comparison of the efficacy and safety of isepamicin and amikacin in the treatment of acute lower respiratory tract infections caused by gram-negative organisms.

In a prospective multicentre open trial, hospitalised adult patients with acute lower respiratory tract infections, mainly pneumonia or bronchitis, were randomised to receive either isepamicin 8 or 15 mg/kg once daily depending on the severity of the infection or amikacin 7.5 mg/kg twice daily. Patients with infections known to be caused by Pseudomonas aeruginosa were to be given concomitant treatment with ceftazidime. In the intent-to-treat population, i.e. patients who received at least one dose randomised treatment, a clinical cure or improvement at the end of treatment was seen in 112/125 (90%) isepamicin patients and 55/60 (92%) amikacin patients. The corresponding rates for patients with a primary diagnosis of pneumonia were 45/52 (87%) and 25/28 (89%). Cure/improvement rates for patients with P. aeruginosa as the causative pathogen (34 of whom also received ceftazidime) were 28/30 (93%) and 16/18 (89%), respectively. In the efficacy population (patients who had a valid pretreatment culture and who met other evaluability criteria), total elimination (documented or presumed if infection had resolved) of target pathogens occurred in 54/63 (86%) of isepamicin patients and 25/30 (83%) of amikacin patients. P. aeruginosa, Escherichia coli, Klebsiella pneumoniae and Staphylococcus aureus were commonly isolated pathogens. Treatment-related adverse were mainly mild or moderate in severity and occurred in 10% of isepamicin patients and 13% of amikacin patients. Four patients (3 isepamicin and 1 amikacin) discontinued treatment because of severe adverse events and a further isepamicin patient withdrew because of a mild adverse event. Nephrotoxicity and ototoxicity occurred infrequently.

Adult↗