scholarly journals Acquisition of Resistant Bowel Flora during a Double-Blind Randomized Clinical Trial of Ertapenem versus Piperacillin-Tazobactam Therapy for Intraabdominal Infections

2005 ◽  
Vol 49 (8) ◽  
pp. 3217-3221 ◽  
Author(s):  
Mark J. DiNubile ◽  
Joseph W. Chow ◽  
Vilas Satishchandran ◽  
Adam Polis ◽  
Mary R. Motyl ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Study Drug ◽  
Resistant Bacteria ◽  
Double Blind ◽  
E Coli ◽  
Double Blind Clinical Trial ◽  
Vancomycin Resistant ◽  
The Impact ◽  
Intraabdominal Infections ◽  
Study Therapy

ABSTRACT Bowel colonization with resistant bacteria can develop in patients receiving broad-spectrum antimicrobial therapy. We compared the impact of two antimicrobial regimens often used to treat intraabdominal infections on susceptibility patterns of bowel flora at the end of therapy. In a double-blind clinical trial, adults with complicated intraabdominal infection requiring surgery were randomized to receive piperacillin-tazobactam (3.375 g every 6 h) or ertapenem (1 g once a day) for 4 to 14 days. Rectal swabs were obtained at baseline and at the end of study therapy to determine the acquisition rates of Enterobacteriaceae resistant to the study drug, extended-spectrum β-lactamase (ESBL)-producing Escherichia coli or Klebsiella species, Pseudomonas aeruginosa resistant to imipenem or piperacillin-tazobactam, and vancomycin-resistant Enterococcus faecalis or Enterococcus faecium. Treated patients were assessable for the acquisition of resistant bacteria if appropriate specimens were obtained at both time points. Enterobacteriaceae resistant to the treatment received were acquired during study therapy by 8/122 assessable piperacillin-tazobactam recipients (6.6%) compared to 0/122 assessable ertapenem recipients (P = 0.007). Neither ESBL-producing E. coli or Klebsiella species nor P. aeruginosa resistant to piperacillin-tazobactam was isolated from patients in either treatment group. Imipenem-resistant P. aeruginosa was acquired by two of the ertapenem recipients (1.6%) versus zero of the piperacillin-tazobactam recipients (P = 0.50). Vancomycin-resistant enterococci were acquired during therapy by 8/125 assessable ertapenem recipients (6.4%) versus 2/123 assessable piperacillin-tazobactam recipients (1.6%; P = 0.10). In this study, the acquisition of resistant Enterobacteriaceae occurred significantly more often in patients treated with piperacillin-tazobactam than in those treated with ertapenem.

scholarly journals Publisher Correction to: BRAINSTORMING: A study protocol for a randomised double-blind clinical trial to assess the impact of concurrent brain stimulation (tDCS) and working memory training on cognitive performance in Acquired Brain Injury (ABI)

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Sara Assecondi ◽  
Rong Hu ◽  
Gail Eskes ◽  
Michelle Read ◽  
Chris Griffiths ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Working Memory ◽  
Brain Injury ◽  
Cognitive Performance ◽  
Acquired Brain Injury ◽  
Working Memory Training ◽  
Memory Training ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
The Impact

Following publication of the original article [1], the authors flagged that the article had published with the Acknowledgements erroneously excluded from the declarations at the end of the article.

scholarly journals The efficacy of antibiotic prophylaxis for impacted and semi-impacted third molar surgery: A prospective randomized double-blind clinical trial

2021 ◽  
Vol 10 (9) ◽  
pp. e58610918398
Author(s):  
Ana Paula Silva Gangá ◽  
Henrique Augusto Pautz Tarantino ◽  
Natália Bermond Arpini ◽  
Tatiany Pimentel Ferreira ◽  
Paula Sampaio de Mello ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Antibiotic Prophylaxis ◽  
Third Molar ◽  
Dental Students ◽  
Third Molar Surgery ◽  
Resistant Bacteria ◽  
Double Blind ◽  
Impacted Third Molar ◽  
Double Blind Clinical Trial

Impacted and semi-impacted third molar surgery is a frequent dental procedure. Due to potentially major tissue manipulation during surgery, antibiotic prophylaxis may be indicated to prevent infection of the surgical wound. This study evaluated the surgical conditions of patients following extraction of impacted and semi-impacted third molars with or without prior antibiotic prophylaxis. Signs of infection and inflammation, postoperative pain level and efficacy of the prescribed drugs were recorded. This was a prospective, randomized, double blind clinical trial with split-mouth design. A total of 23 healthy (ASA I) volunteers with indication for bilateral mandibular third molar extraction were recruited, totaling 46 surgical procedures. One hour prior to the procedure, volunteers received 1g of amoxicillin or placebo and a drug for pain prevention and control. The surgical acts were performed by last-year dental students. Postoperative pain was assessed using a visual analogue scale and an 11-point box scale at selected postoperative intervals of 4 h, 12 h, and 24 h. After seven postoperative days, study volunteers were examined for clinical signs of infection and/or inflammation, such as pus, intra and extraoral swelling, trismus, heat, flushing and temperature change. There were only two cases of postoperative complications, one of intraoral edema (placebo group) and one of trismus (antibiotic prophylaxis group). There were no statistically significant differences for any of the indicative signs of infection. The pain scales revealed no differences between pain levels in both groups at all times evaluated, regardless of the pain scale used (P > 0.05). To conclude, the low infection rate observed in our study does not reflect any need for antibiotic prescription in systemically healthy patients. The adverse effects of antibiotics in addition to selection for resistant bacteria outweigh the benefits of antibiotic prophylaxis in healthy (ASA I) patients.

scholarly journals Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Kiyoshi Takamatsu ◽  
Mariko Ogawa ◽  
Tsuyoshi Higuchi ◽  
Takashi Takeda ◽  
Kunihiko Hayashi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hot Flashes ◽  
Study Drug ◽  
Menopausal Symptoms ◽  
Secondary Outcome ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Traditional Japanese Medicine ◽  
Significant Difference ◽  
Registration Number

Objective. Kampo medicine, a traditional Japanese medicine, is widely used in Japan, especially in the field of menopause medicine. However, few studies have shown evidence-based effects. This study aimed to confirm the effects of kamishoyosan on menopausal symptoms with a randomized, placebo-controlled, double-blind clinical trial. Methods. Subjects were randomly allocated to groups that received either kamishoyosan (n = 101) or a placebo resembling kamishoyosan (n = 104). The primary outcomes were the change in the number of hot flashes, depression scores, improvements of anxiety, quality of life (QOL), and menopausal symptoms before and 4 and 8 weeks after initiation of treatment with the study drug. The secondary outcome was drug safety. Results. After 8 weeks, the number of hot flashes decreased after treatment in both groups, but there was no significant difference between the two groups. The changes in SDS scores showed the same results. Moreover, no significant differences were observed between the two groups in assessments with the STAI, SF-36, and JSOG menopausal index. No serious adverse effect was reported. Conclusions. This first placebo-controlled double-blind randomized trial with kamishoyosan demonstrated that it was safe and had some effects on climacteric symptoms, but not significant compared with placebo. Some problems, such as placebo effects, in the study of Kampo therapy for menopausal symptoms, were revealed. This trial is registered with the trial registration number. UMIN 000006042.

scholarly journals Disassociation of Vitamin D’s Calcemic Activity and Non-calcemic Genomic Activity and Individual Responsiveness: A Randomized Controlled Double-Blind Clinical Trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Arash Shirvani ◽  
Tyler Arek Kalajian ◽  
Anjeli Song ◽  
Michael F. Holick
Keyword(s):  
Gene Expression ◽  
Clinical Trial ◽  
Vitamin D ◽  
Blood Cells ◽  
White Blood Cells ◽  
Double Blind ◽  
Randomized Controlled ◽  
Double Blind Clinical Trial ◽  
The Impact ◽  
Dose Dependent

AbstractThe aims of this randomized controlled double-blind clinical trial were to assess the impact of vitamin D supplementation on calcium metabolism and non-calcemic broad gene expression by relating them to the individual’s responsiveness to varying doses of vitamin D3. Thirty healthy adults were randomized to receive 600, 4,000 or 10,000 IU/d of vitamin D3 for 6 months. Circulating parathyroid hormone (PTH), 25(OH)D, calcium and peripheral white blood cells broad gene expression were evaluated. We observed a dose-dependent increase in 25(OH)D concentrations, decreased PTH and no change in serum calcium. A plateau in PTH levels was achieved at 16 weeks in the 4000 and 10,000 IU/d groups. There was a dose-dependent 25(OH)D alteration in broad gene expression with 162, 320 and 1289 genes up- or down-regulated in their white blood cells, respectively. Our results clearly indicated that there is an individual’s responsiveness on broad gene expression to varying doses of vitamin D3. Vitamin D3 supplementation at 10,000 IU/d produced genomic alterations several fold higher than 4,000 IU/d even without further changes in PTH levels. Our findings may help explain why there are some inconsistency in the results of different vitamin D’s clinical trials.

scholarly journals The Impact of Galactooligosaccharides on the Bioavailability of Sterols: A Randomized, Crossover, Double-Blind Clinical Trial

Proceedings ◽  
2020 ◽  
Vol 70 (1) ◽  
pp. 40
Author(s):  
Virginia Blanco-Morales ◽  
Ramona de los Ángeles Silvestre ◽  
Amparo Alegría ◽  
Guadalupe Garcia-Llatas
Keyword(s):  
Clinical Trial ◽  
Beneficial Effect ◽  
Hypocholesterolemic Effect ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
The Impact

The hypocholesterolemic effect of milk-based fruit beverages enriched with plantsterols (PS) has previously been demonstrated, obtaining a beneficial effect on the seruminflammatory status as well [1]. [...]

scholarly journals The impact of colchicine in preventing postpericardiotomy syndrome; a double-blind clinical trial study

2020 ◽  
Vol 6 (1) ◽  
pp. e11-e11
Author(s):  
Navid Reaza Mashayekhi ◽  
Alireza Alisaeedi ◽  
Alireza Rostami ◽  
Parvin Soltani
Keyword(s):  
Clinical Trial ◽  
Incidence Rate ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Good Effect ◽  
Open Heart ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
The Impact

Introduction: Post-pericardiotomy syndrome is a relatively common complication after open heart surgery. In recent years, colchicine had a good effect on treatment of the pericarditis. Objectives: This study aimed to study the effect of colchicine to prevent post-pericardiotomy syndrome in patients who had open heart surgery. Patients and Methods: This double-blind clinical trial study was conducted on 240 patients undergone open heart surgery. Eligible patients were selected by simple sampling and randomly divided into two groups; 120 subjects in the experimental group receive colchicine (1 mg for patients greater than 70 kg and 0.5 mg for patients lower than 70 kg) and 120 subjects in the control group who received the placebo. Patients were followed up regarding the incidence of post-pericardiotomy syndrome after the surgery during hospitalization and in follow up visits in one month and six months after hospital discharges. Results: In total, the incidence rate of post-pericardiotomy syndrome was 33.7% (81 subjects). A significant difference of post-pericardiotomy syndrome between two groups was seen. We found post-pericardiotomy syndrome in 12.1% (29 patients) of colchicine group versus 21.6% (52 patients) in the placebo group (chi-square test). The incidence rate based on the Kaplan-Meier curve, in the second week to one month after the surgery, was lower in colchicine group while in third to the sixth month it had a constant trend. Conclusion: Colchicine is effective for prevention the post-pericardiotomy syndrome without any life-threatening complication.

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