A randomized, placebo-controlled trial of antimicrobial treatment for children with clinically diagnosed acute sinusitis.

OBJECTIVE: Although antimicrobial treatment for children with acute sinusitis is used commonly, it is unclear whether it offers significant clinical benefit. The purpose of this study was to evaluate the effectiveness of antimicrobial treatments for acute sinusitis as they are used in community pediatric practice. METHODS: We conducted a randomized, placebo-controlled trial in 3 community pediatric practices in St Louis, Missouri. A total of 188 patients who were between the ages of 1 and 18 years and who had had 10 to 28 days of persistent sinus symptoms and a clinical diagnosis of acute sinusitis were randomized to receive 14 days of amoxicillin (40 mg/kg/d in 3 daily doses), amoxicillin-clavulanate (amoxicillin 45 mg/kg/d in 2 daily doses), or placebo. Change in sinus symptoms was assessed both by a quantitative symptom score (the S5 score) and subjectively by the parent. Secondary outcomes included adverse effects of treatment and recurrence or relapse of sinus symptoms. Outcomes were assessed by telephone interviews over a 2-month period. RESULTS: Of the 161 patients who were included in the analysis, 58 received amoxicillin, 48 received amoxicillin-clavulanate, and 55 received placebo. Day 14 improvement rates were 79%, 81%, and 79%, respectively. There were no differences in the 14-day change in S5 score among treatment groups. The rates of adverse events (amoxicillin, 19%; amoxicillin-clavulanate, 11%; placebo, 10%), relapse (amoxicillin, 12%; amoxicillin-clavulanate, 13%; placebo, 13%), and recurrence (amoxicillin, 9%; amoxicillin-clavulanate, 13%; placebo, 13%) of sinus symptoms were similar among treatment groups. CONCLUSION: Neither amoxicillin nor amoxicillin-clavulanate offered any clinical benefit compared with placebo for children with clinically diagnosed acute sinusitis.

Association between resistance to vancomycin and death in cases of Enterococcus faecium bacteremia.

We conducted a retrospective cohort study to determine the association between resistance to vancomycin and mortality among hospitalized patients with Enterococcus faecium bacteremia. We compared outcomes for patients infected with vancomycin-resistant versus vancomycin-susceptible E. faecium among 69 patients with bacteremia defined according to the National Nosocomial Infections Surveillance system. The univariate odds ratio (OR) for death associated with vancomycin resistance was 2.1 (P=.172). After controlling for severity of illness, we found that vancomycin resistance was not associated with mortality (OR, 1.74; 95% confidence interval, 0.5-6.12; P=.39). Vancomycin resistance does not independently increase mortality among patients with E. faecium bacteremia.

Enteric carriage of vancomycin-resistant Enterococcus faecium in patients tested for Clostridium difficile.

OBJECTIVE: To identify independent risk factors for enteric carriage of vancomycin-resistant Enterococcus faecium (VREF) in hospitalized patients tested for Clostridium difficile toxin. DESIGN: Retrospective case-cohort study. SETTING: Tertiary-care teaching hospital. PATIENTS: Convenience sample of 215 adult inpatients who had stool tested for C difficile between January 29 and February 25, 1996. RESULTS: 41 (19%) of 215 patients had enteric carriage of VREE Five independent risk factors for enteric VREF were identified: history of prior C difficile (odds ratio [OR], 15.21; 95% confidence interval [CI95], 3.30-70.10; P < .001), parenteral treatment with vancomycin for > or = 5 days (OR, 4.06; CI95, 1.54-10.73; P = .005), treatment with antimicrobials effective against gram-negative organisms (OR, 3.44; CI95, 1.20-9.87; P = .021), admission from another institution (OR, 2.95; CI95, 1.21-7.18; P =.017), and age > 60 years (OR 2.57; CI95, 1.13-5.82; P = .024). These risk factors for enteric VREF were independent of the patient's current C difficile status. CONCLUSIONS: Antimicrobial exposures are the most important modifiable independent risk factors for enteric carriage of VREF in hospitalized patients tested for C difficile.

The development and validation of an instrument to assess acute sinus disease in children.

Our goal was to produce a reliable, responsive instrument to quantify disease burden in children with acute sinusitis for use in clinical trials. In a cross sectional survey of 1611 community pediatric patients, parents rated the burden attributable to 13 sinus symptoms. Using logistic regression, we identified five symptoms that predicted the clinical diagnosis of sinusitis. The S5 is the average symptom score for nasal obstruction, daytime and nighttime coughing, headache and colored nasal discharge (range 0-3). The S5 was high in children with acute sinusitis (mean = 1.54, SD = 0.77, N = 93), and low in well children (mean = 0.42, SD = 0.56, N = 1019). We assessed reliability and responsiveness of S5 in a prospective cohort study of 41 children with sinusitis. Parents completed a questionnaire at the office visit, at 12 h and 3, 7, 10 and 14 days. Intra-subject reliability at 12 h was excellent (ICC = 0.94). The S5 score was responsive in 24 patients followed for 14 days who improved (mean change = 1.52, SD = 0.12, p = 0.0062). The S5 score is standardized, reliable, responsive, easily obtained, and can be used to determine study eligibility and assess treatment effects without a physician's evaluation.

Meta-analysis of randomized controlled trials comparing laparoscopic and open appendectomy.

We performed a meta-analysis to determine whether laparoscopic or open appendectomy gives better outcomes for patients with suspected acute appendicitis. Studies were selected from the MEDLINE database, personal files, and meeting abstracts. Eleven of 21 randomized controlled trials were included in the meta-analysis. Pooled effect size estimates were calculated using a random effects model. Laparoscopic appendectomy reduced time to full functioning by 5.48 days (95% confidence interval [CI] 3.70 to 7.26; p < 0.001), improved postoperative pain at 24 hours measured by a visual analog scale from 0 to 10 by 1.19 points (95% CI -2.14 to -0.24 points; p=0.014), and decreased the absolute risk for wound infection by 3.2% (95% CI -5.6% to -0. 8%; p=0.009). Operating time was increased by 17.12 min (95% CI 14.19 to 20.03; p < 0.0001). There was no difference between the two surgeries for length of hospital stay, readmission rate, and intra-abdominal abscess formation. Laparoscopic appendectomy improves patient outcomes.