Disease burden and risk factors for hospitalizations associated with rotavirus infection among children in New York State, 1989 through 2000.

OBJECTIVES: To examine trends in hospitalizations for pediatric diarrhea, ascertain the disease burden and risk factors for hospitalizations associated with rotavirus and assess the accuracy of coding for rotavirus hospitalizations in New York State. METHODS: For 1989 through 2000, data were obtained for all diarrhea-associated hospitalizations in New York State among children 1 month through 4 years of age. Characteristics of patients hospitalized with rotavirus were compared with those for hospitalizations with diarrhea from other causes. Medical charts coded as rotavirus diarrhea were reviewed for patients who were discharged during 1997 to determine whether these diagnoses were supported with laboratory results. RESULTS: Diarrhea was reported as a discharge diagnosis in approximately 13% of all hospitalizations for an annual incidence of 83 per 10 000 children. Viruses were the most common etiologic agents reported. Since 1993, when a rotavirus-specific code was introduced, rotavirus infection was coded for 8.7% of all diarrhea-associated hospitalizations. A total of 136 patients with diarrhea died during their hospitalization (hospital fatality rate, 1.6 per 1000), and the 12 deaths among patients with rotavirus had a distinct winter pattern. During 1997 only 46% of the hospitals reporting diarrhea in children used the specific code for rotavirus, and 12% of hospitals reported rotavirus in >30% of all diarrhea-associated hospitalizations. Infants <4 months of age were more likely than older children to be nosocomially infected with rotavirus and had a higher proportion of congenital malformations. CONCLUSION: In New York State diarrhea is a common hospital discharge diagnosis and contributes approximately 13% of all hospitalizations among children <5 years of age. When hospitals with maximum recording were used as a reference point, >30% of diarrhea hospitalizations were recorded as likely the result of rotavirus.

Long-term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis.

INTRODUCTION: Aerosolized tobramycin is a standard of care for chronic Pseudomonas aeruginosa (Pa) infection in patients with cystic fibrosis (CF). OBJECTIVES: The long-term safety and efficacy of intermittent (28-day "on"/"off" cycles) inhaled tobramycin nebulization solution 300 mg/4 ml (TNS4, Bramitob(®)/Bethkis(®)) was assessed over 56 weeks in CF patients aged ≥6 years having baseline 1 sec forced expiratory volume (FEV(1)) 40-80% predicted. METHODS: Patients were initially randomized in an 8-week open-label trial (core phase) to compare TNS4 (N = 159) and tobramycin 300 mg/5 ml (TNS5, TOBI(®)) (N = 165). A subset of patients continued in a 48-week, single-arm extension receiving TNS4 only. The primary endpoint of the core phase was to demonstrate the non-inferiority of TNS4 compared to TNS5 in terms of absolute change from baseline to week 4 in FEV(1) % predicted. The assessment of long-term safety was the primary purpose of the extension phase. Throughout all phases of the study, microbiological assessments, adverse events, and audiometry findings were also evaluated. RESULTS: In the core phase (N = 321), FEV(1) (% predicted) increased from baseline (absolute change) following a single on-treatment cycle for both TNS4 (7.0%) and TNS5 (7.5%) and the non-inferiority between treatments was met [difference between treatments of -0.5 (95% CI: -2.6; 1.6)]. These improvements were maintained throughout the extension phase (N = 209), ranging throughout the study between 5.1% (95% CI: 3.2; 6.9) and 8.1% (95% CI: 6.8; 9.4) compared to baseline. Pa sputum count reductions ranged between 0.6 (95% CI: 0.2; 0.9) to 2.3 (95% CI: 2.0; 2.6) log10 CFU/g throughout the 56 weeks. No remarkable safety issues were identified throughout both study phases, with similar percentages of patients reporting adverse events in the two treatment groups during the 8-week core phase [TNS4 (31.4%); TNS5 (28.0%)]. CONCLUSIONS: Overall, TNS4 demonstrated short-term clinical benefits similar to TNS5 which were maintained during the long-term use of TNS4 and was also associated with a favorable tolerability profile.