Efficacy of ofloxacin otic solution once daily for 7 days in the treatment of otitis externa: a multicenter, open-label, phase III trial.

BACKGROUND: Otitis externa (OE) is an infection of the external auditory canal that is typically treated with topically applied broad-spectrum antibiotics. Twice-daily topical treatment with ofloxacin otic 0.3% solution for 10 days has been reported to be as effective and well tolerated as the standard of care, neomycin sulfate/polymyxin B sulfate/hydrocortisone solution administered 4 times daily for 10 days. OBJECTIVE: This study evaluated the efficacy and safety profile of 7 days of a once-daily regimen of ofloxacin otic 0.3% solution in the treatment of OE. METHODS: This multicenter, open-label, Phase III study was conducted from June 12, 2002, to October 14, 2002. Eligible patients were aged > or = 6 months and had OE of <2 weeks' duration with moderate to severe edema and tenderness involving 1 or both ears and sufficient exudate for microbiologic culture. Ofloxacin otic solution was instilled once daily for 7 days (5 drops for children aged 6 months to <13 years, 10 drops for adolescents/adults aged > or = 13 years). Assessments were conducted at the end-of-treatment visit and 7 to 10 days later (the test-of-cure visit). Medication was supplied free of charge to study participants who incurred no costs for physician visits. RESULTS: Of 489 patients enrolled at 58 sites in 3 countries, 439 were clinically evaluable (173 children, 266 adolescents/adults; 52 % males, 48% females; 47% Hispanic, 45% white; 5% black, and 3% other). The cure rate among clinically evaluable patients was 91% (95% of children, 88% of adolescents/adults); 68% of patients were cured within 7 days. Forty-three potentially pathogenic strains were isolated from 253 microbiologically evaluable patients. Pseudomonas aeruginosa was isolated from 158 (62%) microbiologically evaluable patients and Staphylococcus aureus from 32 (13%). Eradication rates were 96% overall. No serious adverse events were observed. Minor adverse events were experienced by 15 (3%) of 489 patients included in the safety population. The most common adverse events were pruritus (5 patients), increased earache (4 patients), and application-site reactions (3 patients). Overall mean (SD) adherence to therapy was 98% (11.9). CONCLUSIONS: Ofloxacin otic 0.3% solution administered once daily for 7 days was well tolerated and effective in achieving clinical and microbiologic cure of OE. The compliance rates in this study suggests that this regimen may be better accepted by patients than longer, more repetitive regimens.

Declining susceptibility to neomycin and polymyxin B of pathogens recovered in otitis externa clinical trials.

BACKGROUND: Otitis externa is usually treated empirically with topical neomycin/polymyxin B/hydrocortisone. The predominant pathogens associated with this infection are Pseudomonas aeruginosa and Staphylococcus aureus. METHODS: Two multicenter clinical trials (one in adults and adolescents, and one in children), conducted between 1995 and 1996, compared neomycin/polymyxin B/hydrocortisone with ofloxacin for the treatment of otitis externa; two similar trials were conducted between 1999 and 2000. Assessments included the minimum inhibitory concentrations (MICs) of each antimicrobial drug for the major pathogens, bacterial eradication, and clinical efficacy. RESULTS: The MICs of all bacterial isolates (including P. aeruginosa) for neomycin and polymyxin B increased markedly in the 1999 to 2000 studies compared with the 1995 to 1996 studies. In the later studies, mean MICs for all major pathogens tested had increased above the breakpoint for polymyxin B (> or = 4 microg/ml). In contrast, MICs of all isolates for ofloxacin remained similar between the two study periods and were within the susceptible range for this drug. CONCLUSIONS: Although the bacterial eradication rates for both treatments in each study were equivalent, the clinical cure rate for neomycin/polymyxin B/hydrocortisone was lower (87%) than for ofloxacin (93%). Therefore, the organisms most often causing otitis externa appear to be developing resistance to neomycin and polymyxin B but not to ofloxacin.

Surgical management of tracheocutaneous fistula.

Tracheocutaneous fistula (TCF) is a complication of tracheotomy that adds a difficult and bothersome aspect to the patient's care and may exacerbate respiratory disease. Closure of the fistula is recommended, but complications associated with fistula closure include pneumothorax and respiratory compromise. Several surgical approaches have been advocated in the literature. We reviewed the operative techniques and outcomes of TCF closures performed at Cooper Hospital/University Medical Center between February 1990 and April 1995. Direct, or flap, closure of large tracheocutaneous fistulas was associated with significant complications and morbidity. Therefore, the closure technique was modified so that we now recommend, in patients with large tracheocutaneous fistulas (a defect of the anterior tracheal wall of > or = 4 mm diameter), excision of the fistula, replacement of the tracheotomy tube and healing by second intention after a short recannulation period. No complications have occurred since the closure technique was adopted.

Cytomegalovirus infection presenting as chronic sinusitis and nasal polyposis: a case report.

Cytomegalovirus (CMV) is the most common viral opportunistic infection in patients with acquired immunodeficiency syndrome (AIDS), affecting up to 90% of patients. CMV can manifest as primary, latent or chronic persistent infection, most commonly appearing as retinitis, encephalitis or gastrointestinal disease. Other less common presentations, including otolaryngologic expression of the virus, have also been noted. Described here is the first known documented case of CMV with both chronic sinusitis and nasal polyposis in an AIDS patient.

Limited septoplasty for endoscopic sinus surgery.

Septoplasty, in its myriad forms, has been used for decades as a treatment to correct nasal airway obstruction. In some cases septoplasty is done to achieve adequate visualization for further work on the nose or paranasal area. With the onset of FESS the correction of the deviated septum has increasingly been done to facilitate adequate visualization and to allow room for endoscopic instrumentation. Limited septoplasty incorporates parts of both classic nasal septal reconstruction (or Cottle septoplasty) and submucous resection of the septum. Limited septoplasty is primarily used when there is a specific deviation of the septum that limits the ability of the surgeon to accomplish surgical goals-namely, adequate visualization of the surgical field during surgery and during postoperative care. Decreased nasal obstruction is only a secondary consideration for limited septoplasty.

Prediction of piperacillin-tazobactam susceptibility among Enterobacteriaceae, Pseudomonas aeruginosa, and other bacteria using ticarcillin-clavulanic acid, ceftazidime, and other broad-spectrum antimicrobial in vitro test results.

The ability of various in vitro beta-lactam susceptibility test results to predict the susceptibility of piperacillin-tazobactam (a new beta-lactam-beta-lactamase inhibitor combination) was assessed using more than 46,000 recent clinical isolates. The organisms were tested by reference-quality National Committee for Clinical Laboratory Standards (NCCLS) broth microdilution procedures and interpreted by the currently published NCCLS criteria. The recommended antimicrobial tests that would accurately predict the piperacillin-tazobactam in vitro efficacy had an overall very major, false-susceptible rate of only 0.6% (< or = 1.5% is acceptable). The following drug tests can be used to judge piperacillin-tazobactam activity and spectrum (low patient risk) conservatively: for Enterobacteriaceae use ticarcillin-clavulanic acid results (0.6% very major error); for Pseudomonas aeruginosa use piperacillin (0.1%) results; for enterococci use ampicillin or ampicillin-sulbactam (1.8%) results; for Haemophilus influenzae and Moraxella catarrhalis use cefotaxime or cefuroxime or ceftriaxone (1.5%); and for staphylococci use oxacillin by NCCLS recommendations. When the piperacillin-tazobactam testing reagents become available, the direct testing of this combination should be applied to relevant clinical isolates. The piperacillin-tazobactam break points should be reassessed as indicated by the cited minimum inhibitory concentration population analysis to improve predictive accuracy; H. influenzae susceptibility modified to < or = 2/4 micrograms/ml and Enterococcus species susceptibility tested at < or = 16/4 micrograms.

Multicenter evaluation of the in vitro activity of piperacillin-tazobactam compared with eleven selected beta-lactam antibiotics and ciprofloxacin against more than 42,000 aerobic gram-positive and gram-negative bacteria. In Vitro Susceptibility Surveillance Group.

The in vitro activities of piperacillin-tazobactam, 11 other beta-lactam antibiotics, and ciprofloxacin were evaluated in a large multicenter study. A total of 42,208 organisms, collected from 79 listed medical centers and large community hospitals, were tested using the National Committee for Clinical Laboratory Standards broth microdilution procedure. Imipenem (94.7% inhibition), ciprofloxacin (93.8%), and ceftazidime (90.8%) were the most active antibiotics against 31,426 Gram-negative bacilli. Piperacillin-tazobactam (88.8%) and ticarcillin-clavulanate (86.4%) were the most active combination antibiotics against these organisms. Ampicillin-sulbactam (97.8%), piperacillin-tazobactam (96.4%), and imipenem (96.9%) were the most active antibiotics against 10,782 Gram-positive cocci. Overall, the most active antibiotics against all organisms tested were imipenem (95.2%), ciprofloxacin (91.0%), and piperacillin-tazobactam (90.8%).

Bacillus species pseudomeningitis.

A cluster of cerebrospinal fluid Gram's stains showing gram-positive bacilli and of cerebrospinal fluid cultures growing Bacillus species in a large community teaching hospital prompted an epidemiologic and microbiologic investigation. Pseudomeningitis was suspected and confirmed when cultures of uninoculated commercial trypticase soy broth with 5% Fildes enrichment grew Bacillus species. Secondary contamination of the pipettes used for inoculation accounted for the positive cerebrospinal fluid Gram's stains. The costs of this pseudo-outbreak included unnecessary antibiotic therapy, lumbar punctures, and hospitalization. Such adverse effects can be minimized by increased physician awareness of pseudoinfections and by prompt investigation of such occurrences.

Listeria monocytogenes infection in neonates: Investigation of an epidemic.

From March 10 through October 29, 1975, Listeria monocytogenes infection occurred in seven neonates born at a 401-bed general hospital in Greenville, S.C. In the preceding 19 months, there had been only one case. Six of the seven isolates from the infected infants were of serotype JB. Risk of listeriosis in neonates was associated with being born to mothers of low socioeconomic status and being born to mothers who had had vaginitis during pregnancy. Nosocomial transmission of L. monocytogenes appeared unlikely, but the source of the infection is unknown. Of the media used in this study for isolation of L. monocytogenes from mixed cultures, McBride's agar and McBride's agar with nalidixic acid were most useful.

Prophylactic treatment of umbilical stump: comparison of technics.

Three different technics of umbilical stump treatment (alcohol, "triple dye," and providone iodine) were compared. The study revealed a significantly lower rate of colonization with coagulase-positive staphylococci in the group of infants treated with "triple dye."