scholarly journals CSE-1034 versus ceftriaxone: Efficacy and safety analysis from a randomized, open-labeled phase III study in complicated urinary tract infections

2018 ◽  
Vol 10 (4) ◽  
pp. 188 ◽  
Author(s):  
MohdAmin Mir ◽  
Manu Chaudhary ◽  
ShiekhGazalla Ayub
Keyword(s):  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Safety Analysis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Study ◽  
Tract Infections

scholarly journals The Efficacy of a Suppository Based On Phenolmicin P3 And Bosexil (Mictalase®) In Control of Irritative Symptoms in Patients Undergoing Thulium Laser Enucleation of Prostate: A Single-Center, Randomized, Controlled, Open Label, Phase III Study

2021 ◽  
Author(s):  
Riccardo Bertolo ◽  
Chiara Cipriani ◽  
Matteo Vittori ◽  
Marco Carilli ◽  
Francesco Maiorino ◽  
...  
Keyword(s):  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Phase Iii ◽  
Open Label ◽  
Positive Urine ◽  
Open Label Phase ◽  
Group A ◽  
Phase Iii Study ◽  
Laser Enucleation ◽  
Tract Infections

Abstract Background: Several studies described post-operative irritative symptoms after laser enucleation of prostate, sometimes associated with urge incontinence, probably linked to laser-induced prostatic capsule irritation, and potential for lower urinary tract infections We aimed to evaluate the efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase®) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate (ThuLEP).Methods: In this single-center, prospective, randomized, open label, phase-III study, patients with indication to ThuLEP were enrolled (Dec2019-Feb2021 - Institutional ethics committee STS CE Lazio approval no.1/N-726 - ClinicalTrials.gov NCT05130918). The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Mictalase® suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive Mictalase® (“controls”). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering IPSS+QoL questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.Results: 111 patients were randomized: 56 in Group A received Mictalase®. Baseline and perioperative data were comparable. At 15-days, no significant differences were found in terms of IPSS+QoL scores and urinalysis parameters. A significant difference in the rate of positive urine cultures favored Group A (p=0.04). At 30-days follow-up, significant differences were found in median IPSS score (6 [IQR 3–11] versus 10 [5–13], Group A vs B, respectively, p=0.02). Urinalysis parameters and rate of positive urine cultures were not significantly different.Conclusions: The present randomized trial investigated the efficacy of Mictalase® in control of irritative symptoms and prevention of lower urinary tract infections in patients undergoing ThuLEP. IPSS improvement 30-days postoperation was more pronounced in patients who received Mictalase®. Lower rate of positive urine culture favored Mictalase® group 15-days postoperatively. The clinical trial has been registered on ClinicalTrials.gov on November 23rd, 2021 – Registration number NCT05130918.

The Clinical Efficacy and Safety of Bacampicillin Twice Daily in Comparative Studies

1987 ◽  
Vol 15 (1) ◽  
pp. 32-43 ◽  
Author(s):  
M. Blomqvist ◽  
S. Å. Hedström
Keyword(s):  
Urinary Tract ◽  
Chronic Bronchitis ◽  
Urinary Tract Infections ◽  
Comparative Studies ◽  
Adverse Reactions ◽  
Low Frequency ◽  
Effective Dosage ◽  
Efficacy And Safety ◽  
Tract Infections ◽  
Dose Levels

In 16 controlled, randomized, comparative studies a total of 953 patients were treated for urinary tract infection, sinusitis, otitis media or chronic bronchitis. The aim was to evaluate the efficacy and safety of bacampicillin in a twice daily dosage, compared with three times daily dosages of bacampicillin, ampicillin, amoxycillin and a twice daily dosage of co-trimoxazole. Bacampicillin was given in amounts of either 400 or 800 mg to 422 of the patients in these studies. The twice daily dosage of bacampicillin eradicated 89% of the causative bacteria of urinary tract infections compared to 86% with the other regimens. In acute sinusitis 92% and 96% of the patients were either cured or improved when treated with 400 and 800 mg bacampicillin twice daily respectively. Similar percentages occurred in the groups given the three times daily dosages. In exacerbation of chronic bronchitis, 800 mg bacampicillin twice daily was the minimum effective dosage and 84% of the patients were either cured or improved with this regimen. Adverse drug reactions due to bacampicillin at all dose levels were less frequent than those of other anti-microbials. The lowest frequency of diarrhoea, 2.4%, was seen in the group given 400 mg bacampicillin twice daily. Dosages of 400 or 800 mg bacampicillin twice daily had a reliable efficacy combined with a low frequency of adverse reactions in respiratory and urinary tract infections.

scholarly journals Ceftazidime/Avibactam: Who Says You Can’t Teach an Old Drug New Tricks?

2016 ◽  
Vol 19 (4) ◽  
pp. 448 ◽  
Author(s):  
Katie E. Barber ◽  
Jessica K. Ortwine ◽  
Ronda L Akins
Keyword(s):  
Pseudomonas Aeruginosa ◽  
Urinary Tract ◽  
Urinary Tract Infections ◽  
The United States ◽  
Phase Iii ◽  
In Vitro Susceptibility ◽  
Gram Negative ◽  
Tract Infections ◽  
Abdominal Infections

Purpose: Gram-negative resistance continues to rise with treatment options becoming more limited. Ceftazidime/avibactam was recently approved in the United States and Europe, which combines an established third-generation cephalosporin with a new, unique, non-β-lactam β-lactamase inhibitor. This review conducts a thorough examination of structure, pharmacology, spectrum of activity, pharmacokinetics/pharmacodynamics, in vitro and clinical efficacy and safety/tolerability of ceftazidime/avibactam, as well as detailed future directions for the agent. Methods: Pubmed and clinicaltrials.gov searches, as well as abstracts from the 2015 Interscience Conference on Antimicrobial Agents and Chemotherapy/International Society of Chemotherapy (ICAAC/ICC) and ID Week meetings and the 2016 American Society of Microbiology Microbe meeting, were conducted from January 2004 – September 2016. Relevant search terms included ceftazidime, ceftazidime/avibactam, avibactam, NXL104 and AVE1330A. The US package insert for ceftazidime/avibactam (02/2015) and European public assessment report (06/2016) were also reviewed. Results: In vitro susceptibility for ceftazidime/avibactam displayed potent activity against many Enterobacteriaceae including extended-spectrum-β-lactamase (ESBL) and carbapenemase-producing strains, as well as Pseudomonas aeruginosa. Phase II clinical trials utilized for approval demonstrated comparable safety and efficacy to imipenem/cilistatin for treatment of complicated urinary tract infections (70.4% vs. 71.4%) and combined with metronidazole compared to meropenem in complicated intra-abdominal infections (91.2% vs 93.4%). Phase III data displayed non-inferior efficacy of ceftazidime/avibactam compared to doripenem for complicated urinary tract infections (70.2% vs 66.2%) and combined with metronidazole compared to meropenem in complicated intra-abdominal infections (82.5% vs 84.9%), as well as comparable safety. Ceftazidime/avibactam was well-tolerated but does require renal adjustments. Additionally, 3 case series and a single case report have demonstrated the potential for ceftazidime/avibactam against multidrug resistant organisms for compassionate use or failure after previous therapy. Conclusion: By adding avibactam to ceftazidime, clinicians’ antimicrobial armamentarium is expanded, potentially increasing the ability to combat multi-drug resistant gram-negative pathogens, particularly ESBL and carbapenemase-producing organisms, as well as Pseudomonas aeruginosa. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Antibacterial therapy for uncompleted upper urinary tract infections

2020 ◽  
Vol 9 (4) ◽  
pp. 37-40
Author(s):  
Adel S. Al-Shukri ◽  
Elena E. Zakharevich
Keyword(s):  
Antibacterial Activity ◽  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Laboratory Tests ◽  
Upper Urinary Tract ◽  
Efficacy And Safety ◽  
Good Tolerance ◽  
High Antibacterial Activity ◽  
Tract Infections

To evaluate the efficacy and safety of the use of the drug Hileflox 750 (levofloxacin) in the treatment of uncomplicated infections of the upper urinary tract (pyelonephritis). 46 patients (9 men and 37 women) with uncomplicated pyelonephritis were observed. All patients were treated with Hileflox 750 mg orally once a day for 5 days. The drug showed high antibacterial activity, clinical efficacy and good tolerance. During follow-up for 6 months, not one patient showed abnormalities in laboratory tests, the development of complications or relapses of the disease. Conclusions: the results of the study showed the feasibility and effectiveness of the use of the drug Hayleflox 750 for the treatment of uncomplicated pyelonephritis in monotherapy.

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