A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study.

BACKGROUND: Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance. METHODS: In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25). RESULTS: Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each). CONCLUSIONS: Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.

Risk factors for Candida infections in a neonatal intensive care unit in Costa Rica.

OBJECTIVE: To identify potential risk factors associated with Candida infections and compare these risk factors between patients who both died and survived. STUDY DESIGN: A group of patients with positive Candida spp. blood cultures admitted to a neonatal intensive care unit (NICU) in Costa Rica between January 1994 and December 1998. Cases were identified through a computerized search of the microbiology laboratory's database on blood cultures. RESULTS: One hundred and ten newborns were identified. Sixty-six patients (60%) were male; 46 (62%) were preterm infants. Thirty-seven (34%) patients died. Twenty (54%) of them died within three days of the candidemia diagnosis and 17 had disseminated Candida infection on autopsy. Candida albicans and Candida tropicalis were isolated in 90% and 10% of blood cultures, respectively. Mean +/- SD (range) number of days from admission to NICU to the initial positive blood culture were 13.5 +/- 8.5 (1-30) days. Most patients had at least two positive blood cultures (range 1-8). Median (range) days for the sterilization of blood culture were four (1-25) days. Significant differences in survival were identified in patients with axillary-inguinal lesions, apnea and seizures. CONCLUSIONS: Invasive fungal infections are frequent in NICU. Future case-control prospective studies should be carried out to confirm the findings from this report.

Albendazole therapy for Microsporidium diarrhea in immunocompetent Costa Rican children.

BACKGROUND: Microsporidia comprise a large group of obligate intracellular parasites. Although several species have emerged as opportunistic agents in immunocompromised patients, cases have also been reported in immunocompetent patients. METHODS: During 21 months, we conducted a randomized, open label study in 200 children hospitalized with Microsporidium subacute diarrhea. Patients had prolonged, nonbloody, nonmucoid diarrhea, with > or =10 bowel movements/day for >10 days. Patients had negative rotavirus tests, bacterial stool cultures and sugar reductive tests in feces. Stool examinations to rule out Giardia intestinalis and intestinal nematodes were performed. Microsporidium was identified by light microscopy in stool specimens stained with Giemsa and Weber techniques. One hundred patients received oral albendazole (15 mg/kg/day twice a day for 7 days) and 100 patients received only supportive therapy. RESULTS: Both groups were comparable regarding gender, age, clinical evolution and weight. Median (range) age was 24 (6-36) months. All children had abdominal pain, nausea, vomiting and anorexia. The primary endpoint, defined as clinical improvement within 48 h of initial therapy, occurred in 95 and 30% of the albendazole-treated and untreated patients, respectively (P < 0.05). There was a significant decrease in stool frequency, reduction of clinical findings and decrease in Microsporidium parasites in stool specimens of children treated with albendazole compared with the untreated group. Median (range) duration of diarrhea was 5 (3-7) days in albendazole-treated patients versus 10 (8-15) days in untreated patients (P < 0.05). CONCLUSION: Albendazole therapy was effective in improving the clinical manifestations and decreasing the duration of the illness of children with diarrhea caused by Microsporidium.

Parent-reported outcomes for treatment of acute otitis media with cefdinir or amoxicillin/clavulanate oral suspensions.

OBJECTIVE: To compare parent-reported outcomes (satisfaction, tolerability, compliance, and work/daycare missed) for children (aged 6 months to 6 years) receiving either cefdinir or amoxicillin/clavulanate for acute otitis media. METHOD: In a phase IV, investigator-blinded, parallel-group, randomized, multicenter study, parents or legal guardians were asked to complete the Otitis Parent Questionnaire (OPQ) 12-14 days after the first dose of cefdinir or amoxicillin/clavulanate oral suspensions. Responses in each of the outcome domains were analyzed using non-parametric statistical analysis. RESULTS: Of 367 parents/guardians who completed the questionnaire, better ease of use (p = 0.009) and taste (p < 0.0001) were associated with cefdinir versus amoxicillin/clavulanate treatment, and children were significantly more likely to experience vomiting with amoxicillin/clavulanate (16% vs 8%; p = 0.016). Parents also reported that their children were much more likely to take all of their medication if receiving cefdinir (68% vs 53% for amoxicillin/clavulanate; p = 0.005). There were no statistically significant differences between groups in work/daycare missed. CONCLUSION: Based on parents' assessment using the OPQ, cefdinir was easier to administer and tasted better than amoxicillin/clavulanate. Children who received cefdinir also experienced less vomiting and had greater compliance than children who received amoxicillin/clavulanate.

Comparison of five-day cefdinir treatment with ten-day low dose amoxicillin/clavulanate treatment for acute otitis media.

BACKGROUND: Short course beta-lactam antibiotic therapy for acute otitis media (AOM) should improve patient adherence, but it has not been evaluated since the heptavalent pneumococcal conjugate vaccine became routinely used in the United States. METHODS: In a prospective, investigator-blinded, multicenter study, 425 patients, age 6 months-6 years, with a clinical diagnosis of nonrefractory AOM were randomized to receive either 5 days of cefdinir therapy (14 mg/kg divided twice daily) or 10 days of amoxicillin/clavulanate therapy (45/6.4 mg/kg divided twice daily). Clinical response was assessed at end of therapy (2-4 days postantibiotic, respectively) and week 4 (study days 25-28). RESULTS: With no difference in demographics between treatment groups, overall the mean age (+/-SD) was 2.8 +/- 1.8 years, 65% had received conjugated pneumococcal vaccination and 48% had bilateral AOM. The satisfactory clinical response rate at end of therapy was comparable for cefdinir versus amoxicillin/clavulanate (88%, 170 of 194 versus 85%, 164 of 192; 95% CI -4.9, 9.3). Although this must be interpreted with caution, cefdinir showed an apparent trend for higher efficacy than amoxicillin/clavulanate (92%, 72 of 78 versus 77%, 55 of 71; P = 0.019) in a subsample of patients 6-24 months old who had received conjugated pneumococcal vaccination. The incidence of drug-related adverse events was less for cefdinir than for amoxicillin/clavulanate (24%, 50 of 211 versus 38%, 82 of 214; P = 0.0018) CONCLUSION: For children with nonrefractory AOM, based only on clinical endpoints, 5 days of therapy with cefdinir 14 mg/kg divided twice daily was comparable overall with 10 days of therapy with low dose amoxicillin/clavulanate 45/6.4 mg/kg divided twice daily.

Toys in a pediatric hospital: are they a bacterial source?

BACKGROUND: In children's hospitals, children are commonly provided with toys. Measures to guarantee the safety of these toys are usually not taken. This study was conducted to determine whether toys were contaminated with potentially pathogenic bacteria when they arrived in the hospital, and whether they were contaminated in the hospital. METHODS: The study was conducted during a 3-month period. Children who were hospitalized for at least 3 days were chosen as study subjects. Once these children were identified, cultures from their toys were obtained within the first 48 hours of admission. After this first culture, toys were cleaned with 4% chlorhexidine and water and were immediately re-cultured. Following cultures were collected on days 5 to 7, 10 to 15, and every week thereafter until the owner-patient was discharged. Specimens were collected in a standardized manner with moistened swabs and placed in transport media. They were later inoculated onto trypticase soy agar with 5% sheep blood and brain heart infusion agar, incubated at 37 degrees C for 48 hours and examined for colony growth at 24 to 48 hours. RESULTS: Seventy children's toys were included in this study. Patients' median age was 26 months (range: 1 day to 9 years). Respiratory infections (43%) and diarrhea (26%) were the most common causes of hospitalization. Fifty-three (76%) toys were made of plastic, 8 (11%) metallic, and 9 (13%) other materials. Twenty-nine (41%) were brought from home, 38 (55%) were purchased from roving vendors, and 3 (4%) were purchased from toy stores. All first cultures were positive for at least 1 pathogenic microorganism: 55 (78%) coagulase-negative Staphylococcus (CNS); 26 (37%) Bacillus spp; 13 (18%) Staphylococcus aureus; 8 (11%) alpha-hemolytic Streptococcus; 5 (9%), Pseudomonas spp; 2 (3%) Stenotrophomonas maltophilia, and 6 (11%) other gram-negative organisms. After toys were cleaned, subsequent cultures showed significant decreases in bacterial growth rates (P <.05). Because some patients were discharged, additional cultures were obtained for only 31 toys. CONCLUSIONS: Toys entering a hospital can be contaminated with potentially dangerous bacteria and may provide unnecessary risks for nosocomial infection. Effective measures must be implemented to prevent the spread of infections via toys.

Overview of cefdinir: pharmacokinetics, safety, and efficacy in the treatment of uncomplicated skin and skin structure infections.

Uncomplicated skin and skin structure infections commonly are caused by Staphylococcus aureus and Streptococcus pyogenes. Cefdinir, an extended spectrum, third-generation cephalosporin is a safe and effective means of treating skin infections caused by these organisms, as well as many gram-negative pathogens. This article summarizes the pharmacokinetics, dosing schedule, adverse event profile, and efficacy data for cefdinir in adult and pediatric, populations in the treatment of uncomplicated skin and skin structure infections.

Cefdinir versus levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology: a multicenter, randomized, double-blind study.

BACKGROUND: Treatment guidelines for acute bacterial rhinosinusitis (ABRS) recommend 10 to 14 days of therapy with high-dose amoxicillin, amoxicillin/clavulanate, cefdinir, cefpodoxime, cefuroxime, a macrolide, or a newer fluoroquinolone, among other agents. OBJECTIVE: This study compared the clinical efficacy and tolerability of cefdinir and levofloxacin in patients with a diagnosis of acute rhinosinusitis of presumed bacterial origin. METHODS: In this multicenter, double-blind, noninferiority study, ambulatory adult patients who had signs and symptoms for >7 to 21 days before the screening visit and radiographic findings consistent with acute rhinosinusitis were randomized to receive cefdinir 600 mg or levofloxacin 500 mg, each once daily for 10 days. Clinical and radiologic response rates were determined at the test-of-cure (TOC) visit, which took place 9 to 14 days after the completion of treatment. RESULTS: Two hundred seventy-one patients (138 cefdinir, 133 levofloxacin) were enrolled and randomized to treatment at 27 study centers in the United States and Poland between November 2003 and March 2004. Of these, 241 (123 cefdinir, 118 levofloxacin) were clinically evaluable. The cefdinir group consisted of 75 women and 48 men, of whom 117 were white and 6 black; their mean (SD) age was 42.5 (14.3) years. The levofloxacin group consisted of 71 women and 47 men, of whom 111 were white and 7 black; their mean age was 40.4 (13.6) years. The 2 groups were similar in terms of presenting signs and symptoms and baseline radiographic findings. The most common presenting symptoms were sinus pain, sinus pressure, and purulent nasal discharge, each of which was reported by > or =89% of patients. Clinical cure rates at the TOC visit in the cefdinir and levofloxacin groups were 83% (102/123) and 86% (101/118), respectively (95% Cl for the difference in cure rates, -12.3 to 7.0). Cefdinir and levofloxacin were comparable in the treatment of infections classified as moderate to severe. The incidence of drug-related adverse events was generally comparable in the 2 treatment groups, although there were significant differences between cefdinir and levofloxacin in the incidence of vaginal moniliasis in women (11% vs 0%, respectively; P = 0.003), drug-related diarrhea (8% vs 1%; P = 0.005), and insomnia (0% vs 4%; P = 0.027). Only 2% of patients discontinued therapy prematurely as a result of a drug-related adverse event. CONCLUSION: In this population of patients with ABRS, the extended-spectrum cephalosporin cefdinir was as efficacious as the fluoroquinolone levofloxacin, suggesting that cefdinir may be a suitable alternative to the currently recommended fluoroquinolones.

Ganciclovir therapy in cytomegalovirus (CMV) infection in immunocompetent pediatric patients.

OBJECTIVES: To evaluate the outcome of immunocompetent pediatric patients who had positive cytomegalovirus (CMV) antigenemia and received ganciclovir. METHODS: A retrospective review was done of patients who had a CMV infection based on positive antigenemia. Medical charts were reviewed for the following information: age, sex, underlying disease, symptoms and signs, laboratory results, complementary diagnostic procedures, duration and dose of ganciclovir therapy, concomitant medications, complications, and outcome. RESULTS: Sixty-four patients with positive CMV antigenemia were identified; 15 patients were excluded from the study because of their underlying diseases. Of the remaining 49 patients, 26 (53%) were female; the median age was 11.5 months (range 0.3-132 months). Sixty-one percent (30/49) of these patients received ganciclovir (5-10 mg/kg/day) for a median of 14 days (range 7-42 days). Clinical findings included: fever, anemia, hepatomegaly, failure to thrive, elevated liver enzymes, splenomegaly, seizures, and thrombocytopenia. Sixty-three percent (19/30) of the treated patients had negative antigenemia at the end of therapy. CMV antigenemia remained positive in six (20%) patients. Nine patients received a second course of ganciclovir. CONCLUSIONS: Ganciclovir was effective in 80% of patients, as determined by negative antigenemia at the end of therapy.

Epidemiological observations of the judicious use of antibiotics in a pediatric teaching hospital.

OBJECTIVE: This study in a tertiary care teaching center with 361 beds was conducted to assess use, misuse, and abuse of antibiotics. MATERIALS AND METHODS: Every day of the study, a computer program was used to compile a list of patients' bedside records. On a specific day, the bedside charts of selected patients were reviewed to determine whether: (1) a justification for antibiotic prescription was recorded; (2) duration of antibiotic therapy had been defined; (3) suitable cultures had been obtained; and (4) treatment was appropriate for the infection to be treated. For 6 months, charts were evaluated 3 days per week. RESULTS: Of 750 bedside charts 500 (67%) were selected for review. Of the 500 patients, 175 (35%) did not receive antibiotics. The abuses or misuses of antibiotics most frequently observed among the 325 treated patients were no record of justification for the antibiotic prescribed (130/325, 40%); no appropriate blood or fluid samples obtained for culture (45/325, 14%); no subsequent control cultures or cultures obtained before modifying therapy (80/175, 46%); no indication of a planned duration of therapy (180/325, 55%); and improper dosage prescribed in relation to weight (25/325, 8%). Abuse or misuse of antibiotics was more frequently observed among surgical patients than among nonsurgical patients (P<0.05). CONCLUSION: Rational use of antibiotics should be emphasized in every training program as a main strategy to control the increase in drug resistance and to prolong the usefulness of antibiotics.

Síndrome de Stevens-Johnson: experiencia del Hospital Nacional de Niños durante los últimos diez años / Stevens-Johnson syndrome: experience of Hospital Nacional de Niños during the 10 years

Objetivo: Conocer la experiencia del Hospital de Niños acerca del SSJ en los últimos 10 años. Revisar las recomendaciones en relación al manejo del SSJ. Métodos: Se realizó un análisis retrospectivo de los expedientes de los pacientes egresados con el diagnóstico de SSJ, de enero de 1987 a enero de 1997, analizando edad, sexo, procedencia, exposición previa a medicamentos, manifestaciones clínicas, complicaciones y tratamiento. Resultados: Durante 10 años, 26 pacientes fueron egresados del Hospital Nacional de Niños con el diagnóstico de SSJ. 69 por ciento (18/26) fueron varones. La mayoría de los niños provenía de San José. El promedio de edad fue de 5 años, con una mediana de 4 años, y una desviación estandar (DS) de +/- 3.6. La historia de exposición previa a medicamentos fue positiva en el 77 por ciento de los pacientes, siendo los antibióticos los más usados (50 por ciento), seguidos de los anticonvulsivantes (40 por ciento). 69 por ciento de los pacientes tenía historia previa de infección respiratoria superior. Se usaron esteroides en el 42 por ciento de los pacientes, en éstos la estancia hospitalaria fue 6 +/- 7 vrs 11 +/- 11.4. días en aquellos que no los recibieron, p=0.01. Las complicaciones fueron menos frecuentes en el grupo que recibió esteroides (9 por ciento), comparado con el que no recibió esteroides (33 por ciento), p=0.1. No se reportaron muertes por esta patología. Conclusiones: El diagnóstico y particularmente el uso de esteroides en el manejo de pacientes con SSJ es controversial. En esta enfermedad la muerte puede ocurrir debido a varias causas, entre ellas la infección secundaria y el daño visceral. En esta serie, los esteroides parecieron ser benéficos, sin embargo, son necesarios estudios controlados, para establecer su verdadera unidad

Schawannoma maligno epitelioide / Malignant epithelioid schawannoma

Presentamos 4 casos de Schawannoma maligno epitelioide, una rara neoplasia de nervios periféricos. Las edades de aparición oscilan entre 12 y 82 años con predominio masculino (3 casos) sobre muy infrecuente. Su pronóstico es muy ominoso, con menor sobrevida (15 a 20% en 5 años) para aquellos casos asociados con enfermedad de Von Recklinghausen, y mejor para aquellos con tumores menores de 5 cm localizados en porciones distales de extremidades (50 a 75%)

Metástasis en el bazo: frecuencia en 10.749 autopsias / Metastasis of the spleen:frecuency in 10.749 autopsys

Se estudiaron 10.749 autopsias durante el período de 1985 a 1988, donde se demostraron 11 casos de metástasis en el bazo. Eliminando las enfermedades linfoproliferativas, la incidencia fue de 0,1%. Las formas macroscópicas de nódulos múltiples los tumores epiteliales y los tipos histológicos, indiferenciados de los mismos, dominaron la frecuencia

Factores involucrados en la translocación bacteriana en un modelo experimental de obstrucción intestinal / Involucrate factors in bacterial translocation in a experimental model of intestinal obstruction

Se deseño un modelo experimental de obstrucción intestinal (OI) a fin de estudiar las alteraciones histológicas a nivel de la pared intestinal y nódulos linfáticos mesntéricos (NLM). Para tal efecto se utilizaron 32 ratas Sprague-Darley las cuales bajo anestesia con tiopental sódico les fue practicada una laparotomía + ligadura del íleon con seda 3-0 causando oclusión completa de su luz. A diferentes intervalos de producirse la OI (24, 48, 72 y 96 horas), posterior a su sacrificio mediante dislocación cervical se analizaron histológicamete los diferentes grupos. A las 24 horas post OI se apreció congestión y edema de la pared intestinal, presencia de infiltrado celular inflamatorio a nivel de la lámina propia y reactividad de los NLM. A las 48 horas se incrementó el edema y la congestión, se evidenció fragmentación de la mucosa y translocación fragmentación de la mucosa y translocacióy translocación de bacterias a través de ella, las cuales alcanzaron los nódulos linfáticos de la pared. A nivel de los NLM la histiocitosis era mayor. La constatación de TB en la OI amplía aún más el conjunto de alteraciones observadas en esta patología donde no sólo se produce la absorción de productos tóxicos y endotoxinas a nivel del segmento comprometimento y que pudiesen explicar la bacteriemia y la sepsis en este tipo de pacientes