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Prophylactic antibiotics reduce hospitalisations and cost in locally advanced head and neck cancer patients treated with chemoradiotherapy: A randomised phase 2 study.
Ham, JC, Driessen, CM, Hendriks, MP, Fiets, E, Kreike, B, Hoeben, A, Slingerland, M, van Opstal, CC, Kullberg, BJ, Jonker, MA, et al
European journal of cancer (Oxford, England : 1990). 2019;:32-40
Abstract
BACKGROUND Platinum-based chemoradiotherapy for locally advanced head and neck cancer (LAHNC) induces a high rate of acute toxicity, including dysphagia and aspiration pneumonia. We hypothesised that prophylactic antibiotics can prevent pneumonia and hospitalisations and can be cost-effective. PATIENT AND METHODS In this multicentre randomised trial, patients with LAHNC treated with chemoradiotherapy received prophylactic amoxicillin/clavulanic acid from day 29 after the start of treatment until 14 days after completion of chemoradiotherapy or standard care without prophylaxis. The primary objective was to observe a reduction in pneumonias. Secondary objectives were to evaluate the hospitalisation rate, adverse events, costs and health-related quality of life. RESULTS One hundred six patients were included; of which, 95 were randomised: 48 patients were allocated to the standard group and 47 patients to the prophylaxis group. A pneumonia during chemoradiotherapy and follow-up until 3.5 months was observed in 22 (45.8%) of 48 patients in the standard group and in 22 (46.8%) of 47 patients in the prophylaxis group (p = 0.54). Hospitalisation rate was significantly higher in the standard group versus the prophylaxis group, 19 of 48 pts (39.6%) versus 9 of 47 pts (19.1%), respectively (p = 0.03). Significantly more episodes with fever of any grade were observed in the standard group (29.2% vs 10.2%, p = 0.028). A significant difference in costs was found, with an average reduction of €1425 per patient in favour of the prophylaxis group. CONCLUSION Although prophylactic antibiotics during chemoradiotherapy for patients with LAHNC did not reduce the incidence of pneumonias, it did reduce hospitalisation rates and episodes with fever significantly and consequently tended to be cost-effective.
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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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Clavulanic acid can be the component in amoxicillin-clavulanic acid responsible for immediate hypersensitivity reactions.
Torres, MJ, Ariza, A, Mayorga, C, Doña, I, Blanca-Lopez, N, Rondon, C, Blanca, M
The Journal of allergy and clinical immunology. 2010;(2):502-505.e2
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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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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.
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Prophylaxis versus pre-emptive treatment for infective and inflammatory complications of surgical third molar removal: a randomized, double-blind, placebo-controlled, clinical trial with sustained release amoxicillin/clavulanic acid (1000/62.5 mg).
Lacasa, JM, Jiménez, JA, Ferrás, V, Bossom, M, Sóla-Morales, O, García-Rey, C, Aguilar, L, Garau, J
International journal of oral and maxillofacial surgery. 2007;(4):321-7
Abstract
The most common complications after surgical extraction of the third mandibular molar are trismus, oedema or swelling, local pain, dysphagia and infection. The aim of this comparative, double-blind, randomized clinical trial was to evaluate the efficacy of two sustained release amoxicillin/clavulanate regimens in the reduction of infection after third molar extractive surgery. A total of 225 patients were randomized into three equal groups: placebo, prophylaxis with single pre-surgical dose of two tablets amoxicillin/clavulanate 1000/62.5 mg, and pre-emptive post-surgery therapy with two tablets amoxicillin/clavulanate 1000/62.5 mg BID for 5 days. A higher rate of infection (P=0.006) was found among patients receiving placebo (16%) than those receiving single-dose prophylaxis (5.3%) or 5-day pre-emptive therapy (2.7%). A relationship between both the duration (13.8% for long versus 7.4% for medium versus 1.6% for short) and difficulty (12.7% with ostectomy versus 3.5% without ostectomy; P=0.011) of surgical procedure and incidence of subsequent infection was also observed. Both prophylactic and therapeutic regimens versus placebo achieved greater reduction of pain after surgery on day 3 (P=0.001). Logistic regression analysis revealed a risk of infection of 24%, 9% and 4% for ostectomy with placebo, prophylaxis and pre-emptive treatment, respectively, whereas it was 7%, 2% and 1% if ostectomy was not performed. Pre-emptive therapy with the oral sustained release amoxicillin/clavulanate formulation reduced the rate of subsequent infection in patients undergoing ostectomy. Prophylaxis was beneficial in simpler procedures and may be indicated in cases where ostectomy is not performed.
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Moxifloxacin vs amoxicillin/clavulanate in the treatment of acute sinusitis.
Arrieta, JR, Galgano, AS, Sakano, E, Fonseca, X, Amábile-Cuevas, CF, Hernández-Oliva, G, Vivar, R, González, G, Torres, A, ,
American journal of otolaryngology. 2007;(2):78-82
Abstract
PURPOSE The aim of this study was to compare the efficacy and safety of moxifloxacin with that of amoxicillin/clavulanate for the treatment of acute bacterial sinusitis in adults. MATERIALS AND METHODS Five hundred seventy-five patients from Latin American countries were randomized to receive oral moxifloxacin 400 mg once daily for 7 days, or oral amoxicillin/clavulanate 500/125 mg 3 times daily for 10 days, in a prospective, open study. RESULTS At the test-of-cure visit (7-14 days after the end of therapy), the clinical success rate in the moxifloxacin group was 93.4% similar to that in the amoxicillin/clavulanate group (92.7%). Documented bacteriological eradication plus presumed eradication rates in the moxifloxacin (96.5%) and the amoxicillin/clavulanate (96.7%) groups were also similar. Drug-related adverse events were recorded in 32.2% of patients in the moxifloxacin group and 29.7% in the amoxicillin/clavulanate group. Patient discontinuation in the trial due to adverse events occurred for 10 patients in the moxifloxacin group and 6 in the amoxicillin/clavulanate group. CONCLUSIONS Overall, in terms of clinical and bacteriological response, moxifloxacin was equivalent to amoxicillin/clavulanate for the treatment of acute bacterial sinusitis in adults.
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[Clinicomicrobiological monitoring of patients with exacerbation of chronic bronchitis treated with antibacterial drugs].
Dvoretskiĭ, LI, Dubrovskaia, NV, Grudinina, SA, Filimonova, OIu, Iakovlev, SV, Sergeeva, EV, Sidorenko, SV
Terapevticheskii arkhiv. 2006;(3):25-35
Abstract
AIM: To compare clinical and microbiological efficacy of penicillines and macrolids in patients with exacerbation of chronic bronchitis (CB) basing on long-term follow-up after antibacterial treatment. MATERIALS AND METHODS Twenty patients with exacerbated CB or chronic obstructive pulmonary disease (COPD) received amoxicillin/clavulanic acid (augmentin) while 20 other patients were given macrolides (sumamed or clacide). Clinical efficacy was assessed by the rate of exacerbation regression and duration of recurrence-free period in the course of 12-month follow-up. Bacteriological examination was conducted 3-5 days, 1 month after the treatment and at recurrent exacerbation. RESULTS Patients on augmentin showed faster regression of exacerbation, earlier remission and higher quality of remission than patients on macrolides. Eradication of etiologically significant pathogens on day 3-5 after therapy with augmentin and macrolides was achieved in 92 and 30% patients, respectively, persistence--in 8 and 70%, respectively. Mean duration of remission was 263 +/- 107.1 and 164.9 +/- 112,2 days, respectively. A correlation was found between duration of recurrence-free period and frequency of eradication and persistence of the agents after antibacterial therapy of CB and COPD. CONCLUSION Augmentin promotes a significantly earlier regress of exacerbation symptoms and persistent remission. Eradication potential of augmentin in CB/COPD patients is higher than that of macrolides. Long-term post-exacerbation monitoring (12-month follow-up) discovered that recurrence-free period of augmentin-treated patients is much longer than in patients on macrolides.
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Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections.
Malangoni, MA, Song, J, Herrington, J, Choudhri, S, Pertel, P
Annals of surgery. 2006;(2):204-11
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Abstract
OBJECTIVE To compare the safety and efficacy of sequential intravenous (IV) to oral (PO) moxifloxacin treatment against a standard antimicrobial regimen of IV piperacillin-tazobactam followed by PO amoxicillin-clavulanate for the treatment of adults with complicated intra-abdominal infection (cIAI). SUMMARY BACKGROUND DATA cIAIs are commonly due to mixed aerobic and anaerobic bacteria and require both source control and broad-spectrum antibiotic therapy. METHODS A prospective, double-blind, randomized, phase III comparative trial. Patients with cIAI were stratified by disease severity (APACHE II score) and randomized to either IV/PO moxifloxacin (400 mg q24 hours) or comparator (IV piperacillin-tazobactam [3.0/0.375 g q6 hours] +/- PO amoxicillin-clavulanate [800 mg/114 mg q12 hours]), each for 5 to 14 days. The primary efficacy variable was clinical cure rate at the test-of-cure visit (days 25-50). Bacteriologic outcomes were also determined. RESULTS : Of 656 intent-to-treat patients, 379 (58%) were valid to assess efficacy (183 moxifloxacin, 196 comparator). Demographic and baseline medical characteristics were similar between the 2 groups. Clinical cure rates at test-of-cure were 80% (146 of 183) for moxifloxacin versus 78% (153 of 196) for comparator (95% confidence interval, -7.4%, 9.3%). The clinical cure rate at test-of-cure for hospital-acquired cIAI was higher with moxifloxacin (82%, 22 of 27) versus comparator (55%, 17 of 31; P = 0.05); rates were similar for community-acquired infections (80% [124 of 156] versus 82% [136 of 165], respectively). Bacterial eradication rates were 78% (117 of 150) with moxifloxacin versus 77% (126 of 163) in the comparator group (95% confidence interval, -9.9%, 8.7%). CONCLUSIONS Once daily IV/PO moxifloxacin monotherapy was as least as effective as standard IV piperacillin-tazobactam/PO amoxicillin-clavulanate dosed multiple times daily for the treatment of cIAIs.
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Two dosages of clarithromycin for five days, amoxicillin/clavulanate for five days or penicillin V for ten days in acute group A streptococcal tonsillopharyngitis.
Syrogiannopoulos, GA, Bozdogan, B, Grivea, IN, Ednie, LM, Kritikou, DI, Katopodis, GD, Beratis, NG, Applebaum, PC, ,
The Pediatric infectious disease journal. 2004;(9):857-65
Abstract
BACKGROUND Short course antimicrobial therapy is suggested for group A streptococcal tonsillopharyngitis. METHODS The bacteriologic and clinical efficacies of clarithromycin [30 or 15 mg/kg/day twice daily (b.i.d.)] or amoxicillin/clavulanate (43.8/6.2 mg/kg/day b.i.d.) for 5 days or penicillin V (30 mg/kg/day 3 times a day) for 10 days were compared. In a randomized, open label, parallel group, multicenter study, 626 children (2-16 years old) with tonsillopharyngitis were enrolled; 537 were evaluable for efficacy. Follow-up evaluations were performed at 4-8 and 21-28 days after therapy. RESULTS At enrollment, 26% of the Streptococcus pyogenes isolates were clarithromycin-nonsusceptible. All regimens had an apparently similar clinical efficacy. The long term S. pyogenes eradication rates were 102 of 123 (83%) with amoxicillin/clavulanate and 88 of 114 (77%) with penicillin V. In the 30- and 15-mg/kg/day clarithromycin groups, eradication occurred in 71 of 86 (83%) and 59 of 80 (74%) of the clarithromycin-susceptible isolates (P = 0.33), and in 4 of 28 (14%) and 5 of 26 (19%) of the clarithromycin-resistant isolates, respectively (clarithromycin-susceptible versus -resistant, P < 0.0001). Both clarithromycin dosages were well-tolerated. CONCLUSIONS In group A streptococcal tonsillopharyngitis, 5 days of clarithromycin or amoxicillin/clavulanate treatment had clinical efficacy comparable with that of 10 days of penicillin V treatment; however, amoxicillin/clavulanate and penicillin V were bacteriologically more effective than clarithromycin because of its failure to eradicate the clarithromycin-resistant S. pyogenes isolates. The 5-day clarithromycin regimens are not recommended for treatment of streptococcal tonsillopharyngitis in areas where in vitro resistance of group A streptococci to clarithromycin is common.