A randomized, open-label, prospective, multicenter phase-III clinical trial of Elores in lower respiratory tract and urinary tract infections

2013 ◽  
Vol 6 (4) ◽  
pp. 409-414 ◽  
Author(s):  
Manu Chaudhary ◽  
Anurag Payasi
Keyword(s):  
Clinical Trial ◽  
Urinary Tract ◽  
Respiratory Tract ◽  
Urinary Tract Infections ◽  
Lower Respiratory Tract ◽  
Phase Iii ◽  
Open Label ◽  
Phase Iii Clinical Trial ◽  
Multicenter Phase ◽  
Tract Infections

scholarly journals Public Health Laboratory Service. Infections acquired in medical wards

1965 ◽  
Vol 63 (4) ◽  
pp. 457-477 ◽  
Keyword(s):  
Urinary Tract ◽  
Respiratory Tract ◽  
Urinary Tract Infections ◽  
Lower Respiratory Tract ◽  
Malignant Disease ◽  
Skin Lesions ◽  
Reliable Estimate ◽  
Laboratory Service ◽  
Medical Wards ◽  
Tract Infections

A co-operative study was made of the incidence of infection acquired by patients in medical wards. Records were collected of 6740 admissions to 21 wards in 13 hospitals.There were 384 clinical infections (5·7 per 100 patients admitted); 135 of them (35%) were infections of the lower respiratory tract, 72 (19%) were septic skin lesions or infected wounds, and 81 (21%) were urinary tract infections.Infection was believed to have contributed to the death of 59 patients—17% of those infected or 8% of those dying in hospital. Nearly three-quarters of the deaths were attributed to ‘pneumonia’.Acquired infections were most common and most severe at the extremes of age. There was an excess of males over females in staphylococcal infections and in infections of the lower respiratory tract, and of females over males in urinary tract infections.The incidence of infection was above average in patients suffering from malignant disease, diabetes, rheumatoid arthritis, cerebral thrombosis and haemorrhage, and from diseases of the urinary tract and of the skin.There were 110 acquired infections with Staph, aureus and 12 deaths were attributed to them. Over half of these infections were due to staphylococcal strains which caused only one clinical infection in a ward in the course of a year.Pneumonia was difficult to diagnose in severely ill or moribund patients, and its clinical significance was hard to assess. It was not possible to obtain a reliable estimate of the part played by bacterial infection in its causation.

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.

Cefixime in the Treatment of Acute Lower Respiratory Tract and Urinary Tract Infections

1992 ◽  
Vol 4 (1) ◽  
pp. 34-39
Author(s):  
Fu-Der Wang ◽  
Cheng-Yi Liu ◽  
Wing-Wai Wong ◽  
Bor-Shen Hu
Keyword(s):  
Urinary Tract ◽  
Respiratory Tract ◽  
Urinary Tract Infections ◽  
Lower Respiratory Tract ◽  
Tract Infections

scholarly journals A Prospective Open-Label Multicentre Trial on the Use of 1 G, Once Daily Ceftriaxone in Lower Respiratory Tract Infections

1994 ◽  
Vol 5 (suppl c) ◽  
pp. 3C-8C ◽  
Author(s):  
Donald E Low ◽  
Lionel A Mandell
Keyword(s):  
Respiratory Tract ◽  
Treatment Failure ◽  
Lower Respiratory Tract ◽  
Study Drug ◽  
Open Label ◽  
In Vitro Susceptibility ◽  
Once Daily ◽  
Minimal Inhibitory Concentrations ◽  
Tract Infections

This prospective. single open-label sludy was conducted in 14 Canadian centres to assess lhe efncacy of I g, once a day intravenous ceftriaxone treatment administered for a minimum of three days in patients with lower respiratory tract infection. There were 137 patients enrolled. Age varied between 19 and 95 years (mean 68 years). Mosl patients (91 %) were diagnosed with community acquired pneumonia without bacteremia. Most of the cases (82%) were defined as modcralc or severe. Patients received ceftriaxone treatment for an average or five days. Macrolidcs or metronidazole were administered concomitantly wilh ceftriaxone in 34 patienls (25%). After a minimum of three days of ceftriaxone treatment. 59 palicnls (43%) were switched to oral antibiotics. Favourable treatment outcome was found in 92.9% and treatment failure (including relapse of infection) in 7.1 % o lpalicnls. Evaluable patients accounted for 91 % of patients enrolled in the study. Clinical cure and clinical improvement were achieved in 64.6 and 28.3% of the evaluable patients. respectively. Relapse of infection occurred in two patients (1.8%). and treatment failure was recorded in six cases (5.3%). Twelve patients (8.8%) died clue to reasons unrelated to the sludy treatment. Three adverse event (hives, diarrhea and phlebitis at the injection site) were possibly related to the study drug. A cross-Canada in vitro susceptibility surveillance study of bacterial pathogens. frequently the cause of pneumonia. found ceftriaxone to have minimal inhibitory concentrations in 90% of isolates that would support such a dosing regimen. with the exception of Enterobacter species. These rcsults support the use of 1 g, once daily ceftriaxone for the empirical treatment of pneumonia in those patients requiring hospitalization.

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