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1.
Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial.
Ahmed, Z, Uwechue, R, Chandak, P, van Dellen, D, Barwell, J, Heap, S, Szabo, L, Hemsley, C, Olsburgh, J, Kessaris, N, et al
Annals of surgery. 2020;(1):65-71
Abstract
BACKGROUND Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections. METHODS Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI). FINDINGS In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection. INTERPRETATION Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.
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2.
[Not Available].
Steurer, J
Praxis. 2017;(3):155-156
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3.
[Surgical Site Infections after Open Appendectomy and Effectiveness of Complex Approach to Their Prevention].
Golub, AV, Kozlov, RS, Pleshkov, VG, Moskalev, AP, Alibegov, RA, Chelombitko, MA
Khirurgiia. 2016;(6):68-76
Abstract
AIM: To assess an incidence rate of surgical site infections (SSI) after open appendectomy and effectiveness of combined preventive measures (CPM). MATERIAL AND METHODS This study was performed at three surgical departments of Smolensk hospitals. A total of 150 consecutive patients (50 at each department) hospitalized since January 2012 were included into the retrospective observation (period I). In order to perform prospective evaluation of CPM, a total of 66 consecutive patients (randomized 1:1) hospitalized since December 2012 (period II) were followed up at each of the departments. Antibiotic prophylaxis (AP) with IV amoxicillin/clavulanate (1.2 g) was planned for all patients from period II. The study group (group 1) included patients with surgical wound closure with triclosan-coated polyglactin 910 and additionally with a skin 2-octylcyanoacrylate-based adhesive. The control group (group 2) included patients with surgical wound closure with non-triclosan-coated polyglactin 910. Each patient from the period II was assigned to an "Individual SSI Prevention Package" (IPP), which included an antibiotic, sutures, skin adhesive (only in a package for CPM) and label "AP" for patients' medical records. Patients' medical records were reviewed by one expert. Exclusion criteria were: age <14 years; transition to midline laparotomy; drainage of the abdominal cavity through the surgical wound; simultaneous interventions; secondary appendicitis; refusal to use of sutures from the IPP. In order to determine signs of SSI presence/absence within 30 days after surgery, attempts to contact with patients by phone were made. The data obtained was recorded into case report forms and then entered into the study database. RESULTS A total of 322 patients were included into the final analysis (mean age: 34.8±17.1 years). The mean length of hospital stay was 8.2±2.5 days. The mean duration of hospital stay with or without SSI was 7.9±1.8 and 14.2±4.0 days, respectively (p<0.001). The AP during the periods I and II was performed in 56.1% (83/148) and 97.7% (170/174) of patients, respectively (p<0.00001). Cephalosporins I-IV were the most frequently used antibiotics during the period I (85.6%). During the period II, amoxicillin/clavulanate from IPP was used in 98.2% of patients. Percentage of IV antibiotic administration in different time periods was 57.3% and 98.2%, respectively (p<0.0001); frequency of the first administration before skin incision was 53.6% and 97.1%, respectively (p<0.0001). The telephone contact with patient was successful in 74.8% (both periods), 56.8% (period I) and 90.2% (period II) of cases, respectively. SSI was recorded only once per patient with the following priority: SSI was documented in the patient's medical record; patient developed SSI that was not documented (in the expert's opinion) in the patient's medical record; SSI signs were determined during the telephone contact or reported by the patient. The incidence of SSI in both study periods, period I and period II was 14.9%, 15.5% and 14.4%, respectively (p>0.05 for all comparisons). In the patient subgroup with successful telephone contact, the incidence of SSI in both study periods, period I and period II was 17.4%, 21.4% and 15.3%, respectively; the incidence of SSI in group 1 and group 2 of the period II was 12.0% and 18.9%, respectively (p>0.05 for all comparisons). CONCLUSION SSI after an open appendectomy remains an important problem. In order to determine a true incidence of SSI, it is necessary to improve the national nosocomial infection surveillance system. The CMP used in the study have showed a trend to significant SSI risk reduction and may be recommended to maximize patient protection. Further large studies are needed to confirm effectiveness of the proposed CMP.
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[Steroids in addition to antibiotics improve outcome in patients with "community acquired" pneumonia].
Steurer, J
Praxis. 2015;(13):705-6
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Initial antibiotic treatment for acute simple appendicitis in children is safe: Short-term results from a multicenter, prospective cohort study.
Gorter, RR, van der Lee, JH, Cense, HA, Kneepkens, CM, Wijnen, MH, In 't Hof, KH, Offringa, M, Heij, HA, ,
Surgery. 2015;(5):916-23
Abstract
BACKGROUND Initial antibiotic treatment for acute appendicitis has been shown to be safe in adults; so far, not much is known about the safety and efficacy of this treatment in children. The aims of this study were to investigate the feasibility of a randomized controlled trial (RCT) evaluating initial antibiotic treatment for acute appendectomy in children with acute simple appendicitis and to evaluate the safety of this approach. METHODS In a multicenter, prospective cohort study patients aged 7-17 years with a radiologically confirmed simple appendicitis were eligible. Intravenous antibiotics (amoxicillin/clavulanic acid 250/25 mg/kg 4 times daily; maximum 6,000/600 mg/d and gentamicin 7 mg/kg once daily) were administered for 48-72 hours. Clinical reevaluation every 6 hours, daily blood samples, and ultrasound follow-up after 48 hours was performed. In case of improvement after 48 hours, oral antibiotics were given for a total of 7 days. At any time, in case of clinical deterioration or non-improvement after 72 hours, an appendectomy could be performed. Follow-up continued until 8 weeks after discharge. Adverse events were defined as major complications of antibiotic treatment, such as allergic reactions, perforated appendicitis, and recurrent appendicitis. RESULTS Of 44 eligible patients, 25 participated (inclusion rate, 57%; 95% CI, 42%-70%). Delayed appendectomy was performed in 2, and the other 23 were without symptoms at the 8 weeks follow-up. Minor complications occurred in three patients. None of the patients suffered from an adverse event or a recurrent appendicitis. CONCLUSION Our study shows that an RCT comparing initial antibiotic treatment strategy with urgent appendectomy is feasible in children; the intervention seems to be safe.
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Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial.
Chang, AB, Grimwood, K, Wilson, AC, van Asperen, PP, Byrnes, CA, O'Grady, KA, Sloots, TP, Robertson, CF, Torzillo, PJ, McCallum, GB, et al
Trials. 2013;:53
Abstract
BACKGROUND Bronchiectasis unrelated to cystic fibrosis (CF) is being increasingly recognized in children and adults globally, both in resource-poor and in affluent countries. However, high-quality evidence to inform management is scarce. Oral amoxycillin-clavulanate is often the first antibiotic chosen for non-severe respiratory exacerbations, because of the antibiotic-susceptibility patterns detected in the respiratory pathogens commonly associated with bronchiectasis. Azithromycin has a prolonged half-life, and with its unique anti-bacterial, immunomodulatory, and anti-inflammatory properties, presents an attractive alternative. Our proposed study will test the hypothesis that oral azithromycin is non-inferior (within a 20% margin) to amoxycillin-clavulanate at achieving resolution of non-severe respiratory exacerbations by day 21 of treatment in children with non-CF bronchiectasis. METHODS This will be a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial involving six Australian and New Zealand centers. In total, 170 eligible children will be stratified by site and bronchiectasis etiology, and randomized (allocation concealed) to receive: 1) azithromycin (5 mg/kg daily) with placebo amoxycillin-clavulanate or 2) amoxycillin-clavulanate (22.5 mg/kg twice daily) with placebo azithromycin for 21 days as treatment for non-severe respiratory exacerbations. Clinical data and a parent-proxy cough-specific quality of life (PC-QOL) score will be obtained at baseline, at the start and resolution of exacerbations, and on day 21. In most children, blood and deep-nasal swabs will also be collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 21. The main secondary outcome is the PC-QOL score. Other outcomes are: time to next exacerbation; requirement for hospitalization; duration of exacerbation, and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood inflammatory markers will be reported where available. DISCUSSION Currently, there are no published randomized controlled trials (RCT) to underpin effective, evidence-based management of acute respiratory exacerbations in children with non-CF bronchiectasis. To help address this information gap, we are conducting two RCTs. The first (bronchiectasis exacerbation study; BEST-1) evaluates the efficacy of azithromycin and amoxycillin-clavulanate compared with placebo, and the second RCT (BEST-2), described here, is designed to determine if azithromycin is non-inferior to amoxycillin-clavulanate in achieving symptom resolution by day 21 of treatment in children with acute respiratory exacerbations. TRIAL REGISTRATION Australia and New Zealand Clinical Trials Register (ANZCTR) number http://ACTRN12612000010897. http://www.anzctr.org.au/trial_view.aspx?id=347879.
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Is it possible to identify exacerbations of mild to moderate COPD that do not require antibiotic treatment?
Miravitlles, M, Moragas, A, Hernández, S, Bayona, C, Llor, C
Chest. 2013;(5):1571-1577
Abstract
BACKGROUND Anthonisen criteria are widely used to guide the use of antibiotics in exacerbations of COPD. We evaluated the best predictors of outcomes in exacerbations of mild to moderate COPD not treated with antibiotics. METHODS We used data from 152 patients of the placebo arm of a randomized trial of amoxicillin/clavulanate for exacerbations of mild to moderate COPD. Clinical response in relation to Anthonisen criteria and point-of-care serum C-reactive protein (CRP) tests (cutoff, 40 mg/L) was assessed with multivariate logistic regression analysis. RESULTS Clinical failure without antibiotics was 19.9% compared with 9.5% with amoxicillin/clavulanate (P = .022). The only factors significantly associated with an increased risk of failure without antibiotics were the increase in sputum purulence (OR, 6.1; 95% CI, 1.5-25.0; P = .005) and a CRP concentration ≥ 40 mg/L (OR, 13.4; 95% CI, 4.6-38.8; P < .001). When both factors were present, the probability of failure without antibiotics was 63.7%. The Anthonisen criteria showed an area under the curve of 0.708 (95% CI, 0.616-0.801) for predicting clinical outcome. With the addition of CRP level, the area under the curve rose significantly to 0.842 (95% CI, 0.76-0.924; P < .001). CONCLUSIONS Among the Anthonisen criteria, only an increase in sputum purulence is a significant predictor of failure without antibiotics. The use of a point-of-care CRP test significantly increases the predictive accuracy of failure. Both of these easy-to-obtain factors may help clinicians to identify patients with exacerbated mild to moderate COPD who can be safely treated without antibiotics in an ambulatory setting. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT00495586; URL: www.clinicaltrials.gov.
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Does adjuvant antibiotic treatment after drainage of anorectal abscess prevent development of anal fistulas? A randomized, placebo-controlled, double-blind, multicenter study.
Sözener, U, Gedik, E, Kessaf Aslar, A, Ergun, H, Halil Elhan, A, Memikoğlu, O, Bulent Erkek, A, Ayhan Kuzu, M
Diseases of the colon and rectum. 2011;(8):923-9
Abstract
BACKGROUND The risk of fistula formation is a major concern after incision and drainage of an anorectal abscess. OBJECTIVE Our objective was to the test the effects of antibiotic treatment on fistula formation after incision and drainage of anorectal abscesses. DESIGN Randomized, placebo-controlled, double-blind study. SETTING Multicenter trial at 3 teaching hospitals in Turkey. PATIENTS Patients who underwent abscess drainage between September 2005 and January 2008 were evaluated for eligibility. Exclusion criteria included penicillin allergy, antimicrobial agent usage before enrolment, other infection, previous anorectal surgery, inflammatory bowel disease, suspicion of Fournier gangrene, secondary and recurrent anorectal abscesses, anal fistula at time of the surgery, immune compromised states, and pregnancy. INTERVENTION Patients were randomly assigned to receive placebo or amoxicillin-clavulanic acid combination treatment for 10 days after abscess drainage. MAIN OUTCOME MEASURES The primary end point was rate of anorectal fistula formation at 1-year follow-up. RESULTS : Of 334 patients assessed for eligibility, 183 entered the study (placebo, 92; antibiotics, 91). Data were available for per-protocol analysis from 151 patients (placebo, 76; antibiotics, 75) with a mean age of 37.6 years; 118 patients (78.1%) were men. Overall, 45 patients (29.8%) developed anal fistulas during 1-year follow-up. Fistula formation occurred in 17 patients (22.4%) in the placebo group and in 28 patients (37.3%) in the antibiotic group (P = .044). Risk of fistula formation was increased in patients with ischiorectal abscess (odds ratio, 7.82) or intersphincteric abscess (odds ratio, 3.35) compared with perianal abscess. CONCLUSION Antibiotic treatment following the drainage of an anorectal abscess has no protective effect regarding risk of fistula formation.
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Azithromycin extended release vs amoxicillin/clavulanate: symptom resolution in acute sinusitis.
Marple, BF, Roberts, CS, Frytak, JR, Schabert, VF, Wegner, JC, Bhattacharyya, H, Piccirillo, JF, Sanchez, SP
American journal of otolaryngology. 2010;(1):1-8
Abstract
OBJECTIVE The aim of the study was to compare early symptom resolution with a single 2-g dose of azithromycin extended release or 10 days of amoxicillin/clavulanate 875 mg/125 mg every 12 hours in patients with acute sinusitis. MATERIALS AND METHODS This was a prospective, randomized, open-label, observational study to mimic "real-world" conditions, including patients with symptoms of acute bacterial sinusitis lasting between 7 and 30 days. Key symptoms were assessed twice daily by patient diary, and patients were interviewed by telephone at 12 and 28 days. The primary end point was symptom resolution at 5 days, defined as reporting "no problem" with at least 3 of 4 diary symptoms in 2 consecutive measures in the per-protocol population. Secondary end points included additional antibiotic use, sinusitis-related quality of life, and treatment satisfaction. RESULTS Three hundred seventy-eight patients were randomized to a single dose of azithromycin extended release and 371 to 10 days of amoxicillin/clavulanate. In the per-protocol population at day 5, 70/236 patients (29.7%) in the azithromycin extended release arm and 45/238 patients (18.9%) in the amoxicillin/clavulanate arm had resolution of symptoms (difference = 10.8%; 95% confidence interval [CI], 3.1-18.4%). By day 28, 26/236 patients (11.0%) in the azithromycin extended release arm and 27/238 patients (11.3%) in the amoxicillin/clavulanate arm had used additional antibiotics (difference = -0.4%; 95% CI: -6.1% to 5.3%). Additional physician visits, quality of life, and overall satisfaction were similar between groups. CONCLUSIONS More patients randomized to azithromycin extended release experienced symptom resolution at day 5 than those randomized to amoxicillin/clavulanate, without experiencing differences in second antibiotic use at 28 days.
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Prophylaxis after first febrile urinary tract infection in children? A multicenter, randomized, controlled, noninferiority trial.
Montini, G, Rigon, L, Zucchetta, P, Fregonese, F, Toffolo, A, Gobber, D, Cecchin, D, Pavanello, L, Molinari, PP, Maschio, F, et al
Pediatrics. 2008;(5):1064-71
Abstract
OBJECTIVES Febrile urinary tract infections are common in children and associated with the risk for renal scarring and long-term complications. Antimicrobial prophylaxis has been used to reduce the risk for recurrence. We performed a study to determine whether no prophylaxis is similar to antimicrobial prophylaxis for 12 months in reducing the recurrence of febrile urinary tract infections in children after a first febrile urinary tract infection. METHODS The study was a controlled, randomized, open-label, 2-armed, noninferiority trial comparing no prophylaxis with prophylaxis (co-trimoxazole 15 mg/kg per day or co-amoxiclav 15 mg/kg per day) for 12 months. A total of 338 children who were aged 2 months to <7 years and had a first episode of febrile urinary tract infection were enrolled: 309 with a confirmed pyelonephritis on a technetium 99m dimercaptosuccinic acid scan with or without reflux and 27 with a clinical pyelonephritis and reflux. The primary end point was recurrence rate of febrile urinary tract infections during 12 months. Secondary end point was the rate of renal scarring produced by recurrent urinary tract infections on technetium 99m dimercaptosuccinic acid scan after 12 months. RESULTS Intention-to-treat analysis showed no significant differences in the primary outcome between no prophylaxis and prophylaxis: 12 (9.45%) of 127 vs 15 (7.11%) of 211. In the subgroup of children with reflux, the recurrence of febrile urinary tract infections was 9 (19.6%) of 46 on no prophylaxis and 10 (12.1%) of 82 on prophylaxis. No significant difference was found in the secondary outcome: 2 (1.9%) of 108 on no prophylaxis versus 2 (1.1%) of 187 on prophylaxis. Bivariate analysis and Cox proportional hazard model showed that grade III reflux was a risk factor for recurrent febrile urinary tract infections. Whereas increasing age was protective, use of no prophylaxis was not a risk factor. CONCLUSIONS For children with or without primary nonsevere reflux, prophylaxis does not reduce the rate of recurrent febrile urinary tract infections after the first episode.