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1.
High-dose versus standard-dose amoxicillin/clavulanate for clinically-diagnosed acute bacterial sinusitis: A randomized clinical trial.
Matho, A, Mulqueen, M, Tanino, M, Quidort, A, Cheung, J, Pollard, J, Rodriguez, J, Swamy, S, Tayler, B, Garrison, G, et al
PloS one. 2018;(5):e0196734
Abstract
BACKGROUND The recommended treatment for acute bacterial sinusitis in adults, amoxicillin with clavulanate, provides only modest benefit. OBJECTIVE To see if a higher dose of amoxicillin will lead to more rapid improvement. DESIGN, SETTING, AND PARTICIPANTS Double-blind randomized trial in which, from November 2014 through February 2017, we enrolled 315 adult outpatients diagnosed with acute sinusitis in accordance with Infectious Disease Society of America guidelines. INTERVENTIONS Standard-dose (SD) immediate-release (IR) amoxicillin/clavulanate 875 /125 mg (n = 159) vs. high-dose (HD) (n = 156). The original HD formulation, 2000 mg of extended-release (ER) amoxicillin with 125 mg of IR clavulanate twice a day, became unavailable half way through the study. The IRB then approved a revised protocol after patient 180 to provide 1750 mg of IR amoxicillin twice a day in the HD formulation and to compare Time Period 1 (ER) with Time Period 2 (IR). MAIN MEASURE The primary outcome was the percentage in each group reporting a major improvement-defined as a global assessment of sinusitis symptoms as "a lot better" or "no symptoms"-after 3 days of treatment. KEY RESULTS Major improvement after 3 days was reported during Period 1 by 38.8% of ER HD versus 37.9% of SD patients (P = 0.91) and during Period 2 by 52.4% of IR HD versus 34.4% of SD patients, an effect size of 18% (95% CI 0.75 to 35%, P = 0.04). No significant differences in efficacy were seen at Day 10. The major side effect, severe diarrhea at Day 3, was reported during Period 1 by 7.4% of HD and 5.7% of SD patients (P = 0.66) and during Period 2 by 15.8% of HD and 4.8% of SD patients (P = 0.048). CONCLUSIONS Adults with clinically diagnosed acute bacterial sinusitis were more likely to improve rapidly when treated with IR HD than with SD but not when treated with ER HD. They were also more likely to suffer severe diarrhea. Further study is needed to confirm these findings. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02340000.
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2.
Chlorhexidine avoids skin bacteria recolonization more than triclosan.
Macias, JH, Alvarez, MF, Arreguin, V, Muñoz, JM, Macias, AE, Alvarez, JA
American journal of infection control. 2016;(12):1530-1534
Abstract
BACKGROUND We do not know whether differences exist between the residual effect of 2% chlorhexidine in 70% isopropyl alcohol when compared with 1% triclosan in 70% isopropyl alcohol. METHODS Using an analytic, longitudinal, controlled, and comparative experimental trial, with blinded measurements, we recruited healthy, adult volunteers from the University of Guanajuato who completed a stabilization phase of skin microbiota and had no history of skin allergies. Four 25-cm2 areas of the inner surface of the forearms were designated for study: unscrubbed control for establishing baseline bacterial counts, scrubbed control with tridistilled water, scrubbed with chlorhexidine, and scrubbed with triclosan. Quantitative cultures were taken of all the areas at 0, 3, and 24 hours, using agar plates with neutralizing agents. RESULTS A total of 135 healthy volunteers were tested. At 24 hours, the unscrubbed control counts were 288 CFU/cm2, whereas the scrubbed control counts were 96 CFU/cm2; 24 CFU/cm2 for chlorhexidine and 96 CFU/cm2 for triclosan (Kruskal-Wallis χ2H = 64.27; P <.001). CONCLUSIONS Chlorhexidine is the best antiseptic option when a prolonged antiseptic effect is needed; for instance, when implanting medical devices or performing surgical procedures.
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Comparative trial between the use of amoxicillin and amoxicillin clavulanate in the removal of third molars.
Iglesias-Martín, F, García-Perla-García, A, Yañez-Vico, R, Aced-Jiménez, E, Arjona-Gerveno, E, González-Padilla, JD, Gutierrez-Pérez, JL, Torres-Lagares, D
Medicina oral, patologia oral y cirugia bucal. 2014;(6):e612-5
Abstract
OBJECTIVE The purpose of this study was to compare the use of amoxicillin (1g) vs amoxicillin and clavulanate (875/125mg) after extraction of retained third molars for prevention of infectious complications. STUDY DESIGN The study involved 546 patients attending for removal a retained third molar and divided in to two groups: Group 1 - amoxicillin and clavunate (875/125mg) group (n=257) and Group 2 - amoxicillin (1g) group (n=289). All patients were recalled for investigating the possibility of infection, presence of diarrhea and further analgesic intake. RESULTS From a total of 546 patients, the frequency of infection was 1.4%, without no statistically differences between the two groups. Group 1 showed statistically higher presence of patients with gastrointestinal complications (p>0.05). In 546 patients, 2.7% of patients reported severe pain that would not relieve with medication. CONCLUSION The results of our study show that the use of amoxicillin (1g) and amoxicillin and clavunate (875/125mg) is similar efficacious in preventing infection after retained third molar extraction but amoxicillin and clavunate (875/125mg) produces more gastrointestinal discomfort.
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4.
Antibacterial honey for the prevention of peritoneal-dialysis-related infections (HONEYPOT): a randomised trial.
Johnson, DW, Badve, SV, Pascoe, EM, Beller, E, Cass, A, Clark, C, de Zoysa, J, Isbel, NM, McTaggart, S, Morrish, AT, et al
The Lancet. Infectious diseases. 2014;(1):23-30
Abstract
BACKGROUND There is a paucity of evidence to guide the best strategy for prevention of peritoneal-dialysis-related infections. Antibacterial honey has shown promise as a novel, cheap, effective, topical prophylactic agent without inducing microbial resistance. We therefore assessed whether daily application of honey at the exit site would increase the time to peritoneal-dialysis-related infections compared with standard exit-site care plus intranasal mupirocin prophylaxis for nasal carriers of Staphylococcus aureus. METHODS In this open-label trial undertaken in 26 centres in Australia and New Zealand, participants undergoing peritoneal dialysis were randomly assigned in a 1:1 ratio with an adaptive allocation algorithm to daily topical exit-site application of antibacterial honey plus standard exit-site care or intranasal mupirocin prophylaxis (only in carriers of nasal S aureus) plus standard exit-site care (control group). The primary endpoint was time to first infection related to peritoneal dialysis (exit-site infection, tunnel infection, or peritonitis). The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12607000537459. FINDINGS Of 371 participants, 186 were assigned to the honey group and 185 to the control group. The median peritoneal-dialysis-related infection-free survival times were not significantly different in the honey (16·0 months [IQR not estimable]) and control groups (17·7 months [not estimable]; unadjusted hazard ratio 1·12, 95% CI 0·83-1·51; p=0·47). In the subgroup analyses, honey increased the risks of both the primary endpoint (1·85, 1·05-3·24; p=0·03) and peritonitis (2·25, 1·16-4·36) in participants with diabetes. The incidences of serious adverse events (298 vs 327, respectively; p=0·1) and deaths (14 vs 18, respectively; p=0·9) were not significantly different in the honey and control groups. 11 (6%) participants in the honey group had local skin reactions. INTERPRETATION The findings of this trial show that honey cannot be recommended routinely for the prevention of peritoneal-dialysis-related infections. FUNDING Baxter Healthcare, Queensland Government, Comvita, and Gambro.
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5.
[Tympanostomy tubes and otorrhea - how to manage?].
Reinhardt, D
MMW Fortschritte der Medizin. 2014;(15):33
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6.
Sterile water in endoscopy: habit, opinion, or evidence.
Agrawal, D, Rockey, DC
Gastrointestinal endoscopy. 2013;(1):150-2
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Comparison of cefuroxime and co-amoxiclav in the treatment of acute sinusitis in a sample of the Iranian population.
Lari, AR, Alinejad, F, Alaghehbandan, R, Mostafavi, H, Asghari, B, Gholami, A
Le infezioni in medicina. 2012;(4):251-5
Abstract
OBJECTIVES Acute sinusitis is a common upper respiratory tract infection worldwide, which can be severely complicated if inappropriate treatment is applied. The aim of this study was to assess and compare efficacy of cefuroxime and co-amoxiclav in the treatment of acute sinusitis in an Iranian sample population. METHODS A randomized clinical trial, comparing the efficacy of two oral antibiotics, cefuroxime and co-amoxiclav in the treatment of acute sinusitis, was conducted in 2007. A total of 99 patients were enrolled in the study. The clinical diagnosis of acute sinusitis was based on association of suborbital pain, purulent rhinorrhea and purulent discharge on the middle nasal meatus. All patients were also radiographically examined and their diagnoses were confirmed. Patients were randomly assigned to either receive 10 days of treatment with cefuroxime 250 mg twice daily (n=57) or receive co-amoxiclav 500/125 mg three times daily (n=42). Patients responses to treatment were assessed during and at the end of the treatment. RESULTS A satisfactory clinical outcome (cure or improvement of symptoms) was found in 86% (49/57) and 71.4% (30/42) of the clinically evaluable patients treated with cefuroxime or co-amoxiclav, respectively (p >0.05). CONCLUSIONS The findings of this study suggest that cefuroxime (twice daily) is comparably effective as co-amoxiclav (three times a day) in the treatment of patients with acute sinusitis.
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Moxifloxacin versus amoxicillin/clavulanic acid in outpatient acute exacerbations of COPD: MAESTRAL results.
Wilson, R, Anzueto, A, Miravitlles, M, Arvis, P, Alder, J, Haverstock, D, Trajanovic, M, Sethi, S
The European respiratory journal. 2012;(1):17-27
Abstract
Bacterial infections causing acute exacerbations of chronic obstructive pulmonary disease (AECOPD) frequently require antibacterial treatment. More evidence is needed to guide antibiotic choice. The Moxifloxacin in Acute Exacerbations of Chronic Bronchitis TriaL (MAESTRAL) was a multiregional, randomised, double-blind non-inferiority outpatient study. Patients were aged ≥ 60 yrs, with an Anthonisen type I exacerbation, a forced expiratory volume in 1 s < 60% predicted and two or more exacerbations in the last year. Following stratification by steroid use patients received moxifloxacin 400 mg p.o. q.d. (5 days) or amoxicillin/clavulanic acid 875/125 mg p.o. b.i.d. (7 days). The primary end-point was clinical failure 8 weeks post-therapy in the per protocol population. Moxifloxacin was noninferior to amoxicillin/clavulanic acid at the primary end-point (111 (20.6%) out of 538, versus 114 (22.0%) out of 518, respectively; 95% CI -5.89-3.83%). In patients with confirmed bacterial AECOPD, moxifloxacin led to significantly lower clinical failure rates than amoxicillin/clavulanic acid (in the intent-to-treat with pathogens, 62 (19.0%) out of 327 versus 85 (25.4%) out of 335, respectively; p=0.016). Confirmed bacterial eradication at end of therapy was associated with higher clinical cure rates at 8 weeks post-therapy overall (p=0.0014) and for moxifloxacin (p=0.003). Patients treated with oral corticosteroids had more severe disease and higher failure rates. The MAESTRAL study showed that moxifloxacin was as effective as amoxicillin/clavulanic acid in the treatment of outpatients with AECOPD. Both therapies were well tolerated.
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A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections.
Towfigh, S, Pasternak, J, Poirier, A, Leister, H, Babinchak, T
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases. 2010;(8):1274-81
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Abstract
Tigecycline (TGC) has demonstrated clinical efficacy and safety, in comparison with imipenem/cilastatin in phase 3 clinical trials, for complicated intra-abdominal infection (cIAI). The present study comprised a multicentre, open-label, randomized study of TGC vs. ceftriaxone plus metronidazole (CTX/MET) for the treatment of patients with cIAI. Eligible subjects were randomized (1:1) to receive either an initial dose of TGC (100 mg) followed by 50 mg every 12 h or CTX (2 g once daily) plus MET (1-2 g daily), for 4-14 days. The primary endpoint was the clinical response in the clinically evaluable (CE) population at the test of cure (TOC) assessment. Of 473 randomized subjects, 376 were CE. Among these, clinical cure rates were 70.4% (133/189) with TGC vs. 74.3% (139/187) with CTX/MET (95% CI -13.1 to 5.1; p 0.009 for non-inferiority). Clinical cure rates for subjects with Acute Physiological and Chronic Health Evaluation II scores > or =10 were 56.8% (21/37) with TGC vs. 58.3% (21/36) with CTX/MET. The microbiologic response was similar between the two treatment arms, with microbiological eradication at TOC achieved in 68.1% (94/138) of TGC-treated subjects and 71.5% (98/137) of CTX/MET-treated subjects. (The most frequently reported adverse events (AEs) for both treatment arms were nausea (TGC, 38.6% vs CTX/MET, 27.7%) and vomiting (TGC, 23.3% vs CTX/MET, 17.7%). Overall discontinuation rates as a result of an AE were 8.9% and 4.8% in TGC- and comparator-treated subjects, respectively. The results obtained in the present study demonstrate that TGC monotherapy is non-inferior to a combination regimen of CTX/MET with respect to treating subjects with cIAI.
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Antibiotic prophylaxis for orthognathic surgery: a prospective, comparative, randomized study between amoxicillin-clavulanic acid and penicillin.
Jansisyanont, P, Sessirisombat, S, Sastravaha, P, Bamroong, P
Journal of the Medical Association of Thailand = Chotmaihet thangphaet. 2008;(11):1726-31
Abstract
OBJECTIVE The present study was designed to evaluate the prophylactic efficacy after the correction of dentofacial deformities between short- and long-term penicillin and amoxicillin-clavulanic acid. MATERIAL AND METHOD The present study was prospective, randomized, and double blinded. Patients were separated into four groups randomly: short-term and long-term (5 days) penicillin and short-term and long-term (5 days) amoxicillin-clavulanic acid. RESULTS One hundred twenty two patients were assigned randomly into the four groups. Infection developed in a patient in the short-term amoxicillin-clavulanic acid group and in a patient in the long-term penicillin group. CONCLUSION There were no differences in infection between the two groups of antibiotics. Based on the present study, short-term penicillin is still the most appropriate choice for prophylactic antibiotic in orthognathic surgery.