scholarly journals Tolerability and Safety of Urotainer® Polihexanide 0.02% in Long-Term Catheterized Patients: A Prospective Cohort Study

2020 ◽  
Author(s):  
Jürgen Pannek ◽  
Karel Everaert ◽  
Sandra Möhr ◽  
Will Vance ◽  
Frank Van der Aa ◽  
...  
Keyword(s):  
Adverse Events ◽  
Prospective Observational Study ◽  
Bacterial Colonization ◽  
Vital Signs ◽  
Serious Adverse Event ◽  
Pain Scores ◽  
Tract Infections ◽  
Catheter Irrigation

Abstract Background: In patients with long-term indwelling bladder catheters, bacterial colonization is inevitable, leading to urinary tract infections or encrustations with subsequent catheter blockage. Currently, bladder irrigations are the most frequently used prophylactic means, but the best solution remains yet to be determined. In vitro studies demonstrate that polihexanide is a promising option for catheter irrigation, but no data about safety and tolerability exist.Methods: In a prospective observational study in patients with long-term (> 2 weeks) indwelling bladder catheter, a 0.02% polihexanide solution was used to rinse the catheter on five consecutive days. Adverse events, tolerability and vital signs were assessed before, during, after and at the end of the treatment period. Results: There was no serious adverse event in the study. A total of 28 adverse events (AEs) in 15 (46.88%) participants were experienced. Absolute changes in pain scores were not clinically relevant. No incidences of either flushing or sweating were found during instillation. Bladder spasms during instillation were reported in two cases during a single instillation. Mean pulse rates did not change by more than 3 beats per minute. Mean changes in body temperature did not exceed 0.12 °C. Clinically relevant changes in blood pressure were recorded for 3 patients.Conclusions: This is the first study to demonstrate that a 0.02% polihexanide solution can safely be used for catheter irrigation.

scholarly journals Tolerability And Safety Of Urotainer® Polihexanide 0.02% In Long-Term Catheterized Patients: A Prospective Cohort Study

2020 ◽  
Author(s):  
Jürgen Pannek ◽  
Karel Everaert ◽  
Sandra Möhr ◽  
Will Vance ◽  
Frank Van der Aa ◽  
...  
Keyword(s):  
Adverse Events ◽  
Prospective Observational Study ◽  
Bacterial Colonization ◽  
Vital Signs ◽  
Serious Adverse Event ◽  
Pain Scores ◽  
Tract Infections ◽  
Catheter Irrigation

Abstract Background: In patients with long-term indwelling bladder catheters, bacterial colonization is inevitable, leading to urinary tract infections or encrustations with subsequent catheter blockage. Currently, bladder irrigations are the most frequently used prophylactic means, but the best solution remains yet to be determined. In vitro studies demonstrate that polihexanide is a promising option for catheter irrigation, but no data about safety and tolerability exist. Methods: In a prospective observational study in patients with long-term (> 2 weeks) indwelling bladder catheter, a 0.02% polihexanide solution was used to rinse the catheter on five consecutive days. Adverse events, tolerability and vital signs were assessed before, during, after and at the end of the treatment period. Results: There was no serious adverse event in the study. A total of 28 adverse events (AEs) in 15 (46.88%) participants were experienced. Absolute changes in pain scores were not clinically relevant. No incidences of either flushing or sweating were found during instillation. Bladder spasms during instillation were reported in two cases during a single instillation. Mean pulse rates did not change by more than 3 beats per minute. Mean changes in body temperature did not exceed 0.12 °C. Clinically relevant changes in blood pressure were recorded for 3 patients. Conclusions: This is the first study to demonstrate that a 0.02% polihexanide solution can safely be used for catheter Irrigation.

Long-Term Treatment with Pivmecillinam in Patients with Recurrent Bacteriuria

1982 ◽  
Vol 10 (3) ◽  
pp. 179-182
Author(s):  
B Bresky ◽  
K Lincoln
Keyword(s):  
Escherichia Coli ◽  
Adverse Effect ◽  
Renal Function ◽  
Term Treatment ◽  
The Body ◽  
End Of Treatment ◽  
Long Term Treatment ◽  
Tract Infections

Thirty out-patients with chronic recurrent urinary tract infections, who had failed to respond to 10 days treatment with either pivmecillinam and/or amoxycillin, received a 3-month course of pivmecillinam at a dose of 200 mg, three times daily. Twenty-seven patients had bacteriuria due to Enterobacteriaceae, mainly Escherichia coli, sensitive to mecillinam in vitro. Pivmecillinam eradicated all the initial urinary pathogens. Reinfections occurred during treatment in three patients, who remained asymptomatic. Four subjects complained of gastro-intestinal side-effects, and therapy was withdrawn in three instances. Another three patients described unusual adverse events towards the end of the course of treatment, described as an odd sensation in the body and a desire for salt. The sensation disappeared a few days after the end of treatment. Treatment with pivmecillinam had no adverse effect on haematopoietic, hepatic or renal function.

Evaluation of the Antimicrobial Efficacy of Urinary Catheters Impregnated With Antiseptics in an In Vitro Urinary Tract Model

2003 ◽  
Vol 24 (7) ◽  
pp. 506-513 ◽  
Author(s):  
Trupti A. Gaonkar ◽  
Lester A. Sampath ◽  
Shanta M. Modak
Keyword(s):  
Escherichia Coli ◽  
Staphylococcus Aureus ◽  
Pseudomonas Aeruginosa ◽  
Urinary Tract ◽  
Staphylococcus Epidermidis ◽  
Bacterial Colonization ◽  
Silver Sulfadiazine ◽  
Antimicrobial Spectrum

AbstractObjectives:To evaluate the long-term efficacy of urinary Foley catheters (latex and silicone) impregnated with (1) chlorhexidine and silver sulfadiazine (CXS) and (2) chlorhexidine, silver sulfadiazine, and triclosan (CXST) in inhibiting extra-luminal bacterial adherence and to compare their efficacy with that of silver hydrogel latex (SH) and nitrofurazone-treated silicone (NF) catheters.Design:The antimicrobial spectrum of these catheters was evaluated using a zone of inhibition assay. A novel in vitro urinary tract model was developed to study the potential in vivo efficacy of antimicrobial catheters in preventing extraluminal bacterial colonization. The “meatus” was inoculated daily with Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Enterococcus faecalis, Pseudomonas aeruginosa, and Candida albicans. The “bladder” portion of the model was cultured daily to determine bacterial growth.Results:Both CXS and CXST catheters had a broader antimicrobial spectrum than SH and NF catheters. In the in vitro model, CXST latex and silicone catheters exhibited significantly better efficacy (3 to 25 days) against uropathogens, compared with CXS (1 to 14 days) and control (0 to 5 days) catheters (P = .01). CXST latex catheters exhibited significantly longer protection against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, and Pseudomonas aeruginosa, compared with SH catheters (P = .01). CXST silicone catheters resisted colonization with Staphylococcus aureus and Staphylococcus epidermidis for a significantly longer period (23 to 24 days) than did NF catheters (9 to 11 days) (P = .01).Conclusion:Catheters impregnated with synergistic combinations of chlorhexidine, silver sulfadiazine, and triclosan exhibited broad-spectrum, long-term resistance against microbial colonization on their outer surfaces (Infect Control Hosp Epidemiol 2003;24:506-513)

scholarly journals Pharmacokinetics and Short-Term Safety of 873140, a Novel CCR5 Antagonist, in Healthy Adult Subjects

2005 ◽  
Vol 49 (7) ◽  
pp. 2802-2806 ◽  
Author(s):  
Kimberly K. Adkison ◽  
Anne Shachoy-Clark ◽  
Lei Fang ◽  
Yu Lou ◽  
Kathy O'Mara ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Escalation ◽  
Maximum Concentration ◽  
Vital Signs ◽  
Time Profile ◽  
Ccr5 Antagonist ◽  
Repeat Dose ◽  
Serious Adverse Events ◽  
Double Blind

ABSTRACT 873140 is a novel CCR5 antagonist with potent in vitro anti-human immunodeficiency virus (HIV) activity. This study was a double-blind, randomized, placebo-controlled, single- and repeat-dose escalation investigation of the safety, pharmacokinetics, and food effect of 873140 in 70 adult subjects. During single-dose escalation, three cohorts (each composed of 10 subjects, with 8 subjects receiving the active drug and 2 subjects receiving the placebo [8 active and 2 placebo]) received doses of 50, 200, 400, 800, and 1,200 mg after an overnight fast, or 400 mg plus a standard high-fat breakfast in an alternating panel design. During repeat-dose escalation, four cohorts (each with 8 active and 2 placebo) received doses of 200, 400, 600, or 800 mg every 12 h (BID) for 8 days. Laboratory safety tests, vital signs, and electrocardiograms (ECGs) were performed at regular intervals, and blood samples were obtained for pharmacokinetics. Single and repeat doses of 50 mg to 800 mg were well tolerated, with no serious adverse events and no grade 3 or 4 adverse events. The mild-to-moderate side effects were primarily gastrointestinal and included abdominal cramping, nausea, and diarrhea. No specific trends in laboratory parameters or clinically significant ECG changes were noted. Plasma 873140 concentrations increased rapidly; the median time to maximum concentration of drug in serum was 1.75 to 5 h. The median area under the plasma concentration-time profile (AUC) and the maximum concentration of drug in serum (C max) ranged from 127 ng · h/ml and 24 ng/ml at 200 mg BID to 329 ng · h/ml and 100 ng/ml at 800 mg BID, respectively. Food consumption increased the AUC and C max by a mean of 1.7- and 2.2-fold, respectively. The pharmacokinetic and safety profile supports the continued investigation of 873140 with HIV-infected subjects.

scholarly journals Comparison of the effects of Tripterygii totorum and sulfasalazine on rheumatoid arthritis: A retrospective cohort study

2020 ◽  
Vol 19 (2) ◽  
pp. 421-425
Author(s):  
Renchun Huang ◽  
Yongliang Tang ◽  
Jiali Zeng
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Retrospective Cohort ◽  
Therapeutic Potential ◽  
Vital Signs ◽  
Controlled Trials ◽  
American College Of Rheumatology ◽  
Safety Parameters ◽  
Biochemical Indices

Purpose: To compare, in a retrospective study, the effects and safety profiles of Tripterygii totorum and sulfasalazine in patients with rheumatoid arthritis (RA) following 24 weeks of treatment. Methods: RA patients (n = 164) who were treated with Tripterygii totorum or sulfasalazine from August 2012 to February 2016 were included in this study. The major end-point was ≥ 20 % improvement as per American College of Rheumatology (ACR) criterion (ACR 20 response) after 24 weeks. Moreover, ACR 50 and ACR 70 responses were studied. The safety parameters investigated comprised of adverse events, vital signs, as well as hematological and biochemical indices (blood counts, electrolyte levels, and kidney and liver function). Results: At 24 weeks, ACR 20 response was 57.32 % in patients on Tripterygii totorum, while the corresponding value in patients on sulfasalazine was 39.02 % (p = 0.02). In the Tripterygii totorum group, ACR 50 response was 41.46 %, while ACR 70 response was 29.27 %. In sulfasalazine group, ACR 50 response was identified in 26.83 % of the patients, while ACR 70 response was seen in 21.95 % of patients. Adverse events were greater in the Tripterygii totorum group than in sulfasalazine group. Conclusion: These results suggest that Tripterygii Totorum significantly mitigates RA, with a tolerable safety profile. However, there is need for long-term or controlled trials to ascertain the therapeutic potential of Tripterygii totorum in RA. Keywords: Traditional Chinese medicine, Tripterygii totorum, Sulfasalazine, Rheumatoid arthritis

Effect of antibiotic treatment on receptivity of uroepithelial ceils to uropathogens

1988 ◽  
Vol 34 (3) ◽  
pp. 327-331 ◽  
Author(s):  
Gregor Reid ◽  
Andrew W. Bruce ◽  
Mojtaba Beheshti
Keyword(s):  
Urinary Tract ◽  
Antibiotic Treatment ◽  
Term Treatment ◽  
Short Term Treatment ◽  
History Of ◽  
Uroepithelial Cells ◽  
Tract Infections ◽  
Group 1

The management of female patients with recurrent urinary tract infections still remains a problem, and long-term prophylactic or short intermittent courses of antibiotics are the standard forms of therapy. In this report, 10 patients were examined for the effects of long- and short-term treatment with trimethoprim–sulfamethoxazole (TMP–SMX) antibiotics on the receptivity of uroepithelial cells to bacterial adherence. The urine of all patients was sterile while on antibiotic therapy. Few bacteria were found adherent to the cells from adult patients (group 1, mean age 36 years) on long-term antibiotics, but the cells were highly receptive to uropathogens in vitro, especially for Escherichia coli expressing mannose-resistant adhesins. Controls of age-matched adult females were included and in vitro adherence levels were found to be higher for those women with a history of urinary tract infection compared with those with no past record of infection. In the second group, elderly patients (mean age 87 years) presented with bacteriuria, and their uroepithelial cells were found to be colonized by uropathogens to a significantly greater extent than their controls. The adherent population was reduced during 7-day TMP–SMX antibiotic treatment, but increased posttherapy, particularly in two patients who subsequently became reinfected. The in vitro results showed that uroepithelial cells retain their receptivity to uropathogenic adherence, both during and after treatment. Although antibiotics eradicate uropathogens from the urinary tract, patients remain susceptible to recolonization by uropathogens and are at risk of reinfection after completion of therapy.

scholarly journals Tofacitinib downregulates antiviral immune defence in keratinocytes and reduces T cell activation

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Heike C. Hawerkamp ◽  
Alina Domdey ◽  
Lisa Radau ◽  
Philipp Sewerin ◽  
Péter Oláh ◽  
...  
Keyword(s):  
T Cells ◽  
Adverse Events ◽  
T Cell Activation ◽  
Antiviral Immunity ◽  
Janus Kinase ◽  
Activation Process ◽  
Upper Respiratory Tract ◽  
Antiviral Peptides ◽  
Tract Infections

Abstract Background Tofacitinib is a novel Janus kinase (JAK) inhibitor approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. In clinical trials, the most common adverse events observed were nasopharyngitis, upper respiratory tract infections, and zoster. JAKs are found downstream of the type II cytokine receptor family used by a number of TH17 cell-associated cytokines for signal transduction. These cytokines lead to the secretion of antiviral and antimicrobial peptides (AMPs) by keratinocytes or synoviocytes. Blocking the JAK pathway might result in a diminished secretion of antimicrobial and antiviral peptides causing higher susceptibility to infections in patients treated with JAK inhibitors. Methods We treated primary human keratinocytes and synoviocytes with tofacitinib and subsequently added various cytokines and bacterial surface proteins before evaluation of the response via RT-qPCR. CD69 expression on tofacitinib-treated PBMCs was investigated via flow cytometry. Results We found a markedly reduced gene expression of all tested antiviral peptides such as MX1 or ISG15 in keratinocytes and synoviocytes in the presence of tofacitinib in vitro. Additionally, we found that JAK inhibition reduced activation of T cells after stimulation with bacterial LPS or viral VZV gE. Conclusions The antiviral immunity is strongly inhibited in the presence of tofacitinib in vitro, while the antimicrobial immunity does not seem to be affected. In T cells, the overall activation process seems to be influenced by tofacitinib. These findings suggest that tofacitinib has an impact on antiviral immunity such as patients treated with tofacitinib often show adverse events like herpes zoster. Graphical abstract

Long-Term Safety and Effectiveness of Mixed Amphetamine Salts Extended Release in Adults With ADHD

CNS Spectrums ◽  
2005 ◽  
Vol 10 (S20) ◽  
pp. 16-25 ◽  
Author(s):  
Joseph Biederman ◽  
Thomas J. Spencer ◽  
Timothy E. Wilens ◽  
Richard H. Weisler ◽  
Stephanie C. Read ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adult Adhd ◽  
Extended Release ◽  
Rating Scale ◽  
Vital Signs ◽  
Therapeutic Effects ◽  
Open Label ◽  
Dose Escalation Study ◽  
Double Blind

AbstractObjective: Assess the long-term safety and effectiveness of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD) combined subtype.Methods: A 24-month, open-label extension of a 4-week, multicenter, double-blind, placebo-controlled, parallel-group, forced–dose-escalation study of MAS XR in adults (≥ 18 years of age) with ADHD. The 223 enrolled subjects started treatment at 20 mgl day for 1 week, with subsequent titration up to 60 mgl day for optimal therapeutic effects. At monthly visits, efficacy was assessed based on the ADHD Rating Scale IV (ADHD-RS-N). Safety assessments included spontaneously reported adverse events, laboratory assessments, and monitoring of vital signs.Findings: ADHD symptoms significantly improved for all subjects as measured by change from baseline in mean ADHD-RS-IV total scores (-7.2±13.04 unit points; P<.001); this was sustained for up to 24 months. The most common treatment-related adverse events were dry mouth (43% of subjects reporting at least one occurrence), infection (33%), insomnia (32%), anorexia/decreased appetite (32%), headache (30%), and nervousness (26%). Most adverse events were mild to moderate in intensity.Conclusion: Treatment with MAS XR 20–60 mgl day for adult ADHD was generally well tolerated and was associated with sustained symptomatic improvement for up to 24 months.

scholarly journals Safety and Pharmacokinetics of CD101 IV, a Novel Echinocandin, in Healthy Adults

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
Taylor Sandison ◽  
Voon Ong ◽  
Jonathan Lee ◽  
Dirk Thye
Keyword(s):  
Adverse Events ◽  
Vital Signs ◽  
High Plasma ◽  
Primary Objective ◽  
Healthy Adults ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Content Type

ABSTRACT CD101 IV is a novel echinocandin with distinctive pharmacokinetic properties that is being developed as a once-weekly treatment for candidemia and invasive candidiasis. CD101 has potent in vitro activity and in vivo efficacy against a broad range of Candida and Aspergillus species. The primary objective of two randomized, double-blind, placebo-controlled, dose-escalation studies in healthy adults was to determine the safety and tolerability of CD101 IV. Sequential cohorts of 8 subjects (n = 6, active; n = 2, placebo) were administered single (50, 100, 200, 400 mg) or multiple once-weekly (100 mg given once weekly for two weeks [×2], 200 mg ×2, 400 mg ×3) doses of CD101 IV infused over 1 h. There were no deaths, serious adverse events (SAEs), severe adverse events (AEs), or withdrawals from the study due to an AE. The majority of AEs were mild, and all completely resolved. There was a higher incidence of total AEs and mild transient infusion reactions in the 400-mg ×3 dose group. There were no clinically meaningful trends in postbaseline laboratory abnormalities and no safety issues related to electrocardiograms, vital signs, or physical exams. CD101 showed dose-proportional plasma exposures, minor accumulation (30% to 55%), low apparent clearance (<0.28 liter/h), long half-life (t 1/2) (>80 h), and minimal urine excretion. CD101 IV was safe and well tolerated at single and multiple doses of up to 400 mg given once weekly for 3 weeks and exhibited a long t 1/2, minimal accumulation over several weeks, negligible renal excretion, and high plasma exposures enabling once-weekly dosing.

scholarly journals P077: Subcutaneous fentanyl administration for pain management in prehospital setting

CJEM ◽  
2016 ◽  
Vol 18 (S1) ◽  
pp. S104-S104
Author(s):  
J. Lebon ◽  
F. Bégin ◽  
R. Fleet ◽  
A.B. Tanguay
Keyword(s):  
Pain Management ◽  
Pain Relief ◽  
Adverse Events ◽  
Age Groups ◽  
Vital Signs ◽  
Hospital Setting ◽  
Emergency Medical Technician ◽  
Transport Time ◽  
Pain Scores ◽  
Fentanyl Administration

Background: Intravenous (IV) and Intranasal (IN) route for analgesic administration cannot always be used to provide adequate pain management in pre-hospital setting. Objective: In a rural and suburban pre-hospital setting, studying the feasibility, safety and effectiveness of the subcutaneous (SC) route for fentanyl administration by Basic Life Service-Emergency Medical Technician (BLS-EMT) for pain management, with the support of an online medical control (OLMC) center. Methods: Retrospective study of patients who received subcutaneous fentanyl and were transported by BLS-EMT to an emergency department (ED). Safety and feasibility were characterized by collecting vital signs, Ramsey sedation scores and adverse events following fentanyl administration, and effectiveness was evaluated by changes in pain scores. Parametric and non-parametric tests were used for statistical analyses comparing age groups (<70 & ≥70 years old) regarding transport time. Results: Pain scores ≥7 were found in 288 patients (14-93 years old) who were eligible for analgesia. 249 (86.5%) of the 284 (98.6%) who received subcutaneous fentanyl were included for analysis. At baseline, no difference (p>0.05) in pain scores pre-fentanyl between groups even if patients<70 years old received a significant higher dose of fentanyl than those ≥70 years old (1.4±0.3 v/s 0.8±0.2mcg/kg, p<0.05). Post-administration pain score decreased significantly while proportion of patients achieving a pain relief increased significantly (p<0.05) regarding transport time (15, 30 or 45min) to ED. Adverse events were present in 1.6% of the patients [hypotension (n=2; 0.8%), nausea (n=1; 0.4%), and Ramsey score>3 (n=1; 0.4%)]. Conclusion: Under the supervision of an OLMC center, subcutaneous fentanyl administration by BLS-EMT for pain management seems to be a feasible approach, with a safe and effective route without major adverse event in pre-hospital setting. Pain relief increased with longer transport time. Further studies are needed to determine the benefits of SC route when compared to other administration routes in EMS.

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