-
BMC Infectious Diseases Dec 2016Uncomplicated lower urinary tract infections (LUTI) are very common, and presumably around 200,000 female patients are treated for this annually in Denmark. The current... (Randomized Controlled Trial)
Randomized Controlled Trial
The efficacy of pivmecillinam: 3 days or 5 days t.i.d against community acquired uncomplicated lower urinary tract infections - a randomized, double-blinded, placebo-controlled clinical trial study protocol.
BACKGROUND
Uncomplicated lower urinary tract infections (LUTI) are very common, and presumably around 200,000 female patients are treated for this annually in Denmark. The current Danish national clinical practice guidelines recommend pivmecillinam as a first-line drug (i.e., 400 mg t.i.d. for 3 days). Pivmecillinam is also one of the first-line drugs recommended in the international guidelines for LUTIs (i.e., 400 mg b.i.d. for 5 days). The international recommended duration is based on evidence saying that a 7-day regimen is better than a 3-day regimen. However, no data says that a 5-day regimen is superior to a 3-day regimen. With this study we aim to identify and to compare the efficacy of pivmecillinam 400 mg t.i.d in a 3-day respectively 5-day regimen, against community acquired uncomplicated LUTI, i.e., in women at the age of 18-70 year old.
METHOD/DESIGN
The general practitioner will at consultation give a suitable patient the opportunity to participate in the study. If the patient will give her consent, a double-blinded kit (i.e., the antibiotic with/without placebo, questionnaires and self-urinary samples) will be given to the patient. We aim for 161 evaluable patients in each arm.
DISCUSSION
Pivmecillinam is an excellent choice against urinary tract infections and we believe this study will fill in the gaps and strengthen the evidence on the treatment against one of the most common infections in our society. Thus, aiming to provide a more rational and ecological beneficial antimicrobial therapy.
TRIAL REGISTRATION
EudraCTno.: 2014-001321-32 .
Topics: Adolescent; Adult; Aged; Amdinocillin Pivoxil; Anti-Bacterial Agents; Anti-Infective Agents, Urinary; Denmark; Double-Blind Method; Drug Administration Schedule; Female; Humans; Middle Aged; Prospective Studies; Urinary Tract Infections; Young Adult
PubMed: 27905884
DOI: 10.1186/s12879-016-2022-0 -
BMC Infectious Diseases Nov 2016The prevalence of urinary tract infections (UTIs) caused by extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae is increasing and the therapeutic options...
BACKGROUND
The prevalence of urinary tract infections (UTIs) caused by extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae is increasing and the therapeutic options are limited, especially in primary care. Recent indications have suggested pivmecillinam to be a suitable option. This pilot study aimed to assess the viability of pivmecillinam as a therapeutic option in a Dublin cohort of mixed community and healthcare origin.
METHODS
A prospective measurement of mean and fractional inhibitory concentrations of antibiotic use in 95 patients diagnosed with UTI caused by ESBL-producing Enterobacteriaceae was carried out. 36 % patients were from general practice, 40 % were admitted to hospital within south Dublin, and 25 % samples arose from nursing homes. EUCAST breakpoints were used to determine if an isolate was sensitive or resistant to antibiotic agents.
RESULTS
Sixty-nine percent of patients (N = 66) with urinary ESBL isolates were female. The mean age of females was 66 years compared with a mean age of 74 years for males. Thirty-six percent of isolates originated from primary care, hospital inpatients (26 %), and nursing homes (24 %). The vast majority of ESBL isolates were E. coli (80 %). The E tests for mecillinam and co-amoxiclav had concentration ranges from 0.16 mg/L up to 256 mg/L. The mean inhibitory concentration (MIC) of mecillinam ranged from 0.25 to 256 mg/L, while co-amoxiclav MICs ranged from 6 to 256 mg/L. The percentage of isolates resistant to mecillinam and co-amoxiclav was found to be 5.26 and 94.74 % respectively.
CONCLUSIONS
This is the first study exploring the use of pivmecillinam in an Irish cohort and has demonstrated that its use in conjunction with or without co-amoxiclav is an appropriate and useful treatment for urinary tract infections caused by ESBL-producing organisms.
Topics: Aged; Amdinocillin; Amdinocillin Pivoxil; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Drug Resistance, Bacterial; Escherichia coli; Escherichia coli Infections; Female; General Practice; Gram-Negative Bacteria; Gram-Negative Bacterial Infections; Hospitalization; Hospitals; Humans; Ireland; Klebsiella Infections; Klebsiella pneumoniae; Male; Microbial Sensitivity Tests; Nursing Homes; Pilot Projects; Prevalence; Prospective Studies; Risk Factors; Urinary Tract Infections; beta-Lactamases
PubMed: 27806687
DOI: 10.1186/s12879-016-1797-3 -
Medecine Et Maladies Infectieuses Dec 2016Pivmecillinam is a safe beta-lactam for use in pregnancy. It has been widely used for the treatment of lower urinary tract infections (UTIs) in the Nordic countries... (Comparative Study)
Comparative Study
OBJECTIVES
Pivmecillinam is a safe beta-lactam for use in pregnancy. It has been widely used for the treatment of lower urinary tract infections (UTIs) in the Nordic countries where its efficacy, minor impact on the microbiota, and low level of resistance among the Escherichia coli strains have been proven. However, susceptibility data related to E. coli involved in asymptomatic bacteriuria and lower UTIs in pregnant women is lacking. We aimed to support the 2015 recommendations issued by the French Infectious Diseases Society (SPILF) on gestational UTI, with a particular focus on pivmecillinam.
MATERIAL AND METHODS
Antimicrobial susceptibility testing was performed by 12 hospitals with a maternity department on 235 E. coli strains isolated from the urine of pregnant women. Susceptibility to mecillinam was tested by disk diffusion method using the 2015 recommendations of the antibiogram committee of the French microbiology society (CA-SFM).
RESULTS
Global susceptibility to mecillinam was 86.4%. Susceptibility to mecillinam was 96.5% for strains susceptible to amoxicillin-clavulanic acid and 38.7% for resistant strains. All six extended-spectrum beta-lactamase-producing E. coli strains were susceptible to mecillinam.
CONCLUSION
Given the efficacy and safety of pivmecillinam during pregnancy, it may be used for the documented treatment of asymptomatic bacteriuria and acute cystitis in pregnant women. It also represents an alternative for the treatment of multidrug-resistant bacterial infections.
Topics: Adult; Amdinocillin; Amdinocillin Pivoxil; Anti-Bacterial Agents; Asymptomatic Diseases; Bacterial Proteins; Bacteriuria; Disk Diffusion Antimicrobial Tests; Drug Resistance, Microbial; Escherichia coli Infections; Female; Humans; Pregnancy; Pregnancy Complications, Infectious; Prodrugs; Prospective Studies; Urinary Tract Infections; Urine; Uropathogenic Escherichia coli; beta-Lactamases
PubMed: 27609597
DOI: 10.1016/j.medmal.2016.07.007 -
Infectious Diseases (London, England) Oct 2016Pyelonephritis is a common infection in childhood and may cause renal scarring. The aim was to determine an effective oral antibiotic treatment of first time...
BACKGROUND
Pyelonephritis is a common infection in childhood and may cause renal scarring. The aim was to determine an effective oral antibiotic treatment of first time pyelonephritis in children.
METHODS
The study is a retrospective analysis of positive urine cultures collected at a Danish paediatric department from 2010-2013. Urine samples from 378 children aged 0-15.9 years, without renal anomalies and treated for first time pyelonephritis, were included. The urine pathogens and antimicrobial susceptibilities were analysed.
RESULTS
The most common aetiologic agents found were Escherichia coli (85%), Klebsiella species and other Enterobacteriaecea (9.7%) and Enterococcus species (5.3%). Escherichia coli was significantly more common in girls than in boys (90% vs 74%, p < 0.001) and in children older than 6 months (89% vs 77%, p < 0.001). Children younger than 6 months had a higher prevalence of other Gram-negative rods (16% vs 7%, p < 0.001). These differences may be due to boys representing 63% of patients in the youngest age group compared to 16% of older children (p < 0.001). For all urine isolates, piv-mecillinam and amoxicillin-clavulanate had the lowest resistance rates of 6.9% and 7.2%, respectively, and 6% for both antimicrobials in patients older than 6 months. Uropathogens from boys above 6 months of age were more resistant to piv-mecillinam compared to girls (25% vs 2.4%, p < 0.001).
CONCLUSION
This study recommends piv-mecillinam or amoxicillin-clavulanate as empirical treatment of first time pyelonephritis in Danish children from 6 months of age. Age and gender of patients should be taken into consideration when initiating empirical treatment.
Topics: Administration, Oral; Adolescent; Age Factors; Amdinocillin Pivoxil; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Denmark; Drug Resistance, Bacterial; Enterococcus; Escherichia coli; Female; Hospitals, Pediatric; Humans; Infant; Infant, Newborn; Klebsiella; Male; Pyelonephritis; Retrospective Studies; Sex Factors; Urine
PubMed: 27300266
DOI: 10.3109/23744235.2016.1168937 -
Infectious Diseases (London, England) 2016The purpose of the study was to evaluate how use of antibiotics precedes the presence of ESBL-producing E.coli in general practice. The authors performed a...
The purpose of the study was to evaluate how use of antibiotics precedes the presence of ESBL-producing E.coli in general practice. The authors performed a triple-case-control study where three case groups were individually compared to a single control group of uninfected individuals. Urine samples were prospectively collected and retrospective statistical analyses were done. This study included 98 cases with urinary tract infection (UTI) caused by ESBL-producing E. coli, 174 with antibiotic-resistant (non-ESBL) E. coli, 177 with susceptible E. coli and 200 with culture negative urine samples. Case groups had significantly higher use of antibiotics than the control group within 30 days before infection (p < 0.0001). The ESBL group had significantly more hospital admissions than the other case groups (p < 0.05). Hospital admission was an independent risk factor for community onset UTI by ESBL-producing E. coli. Exposure to antibiotics was a risk factor for UTI with E. coli, while prior antibiotic usage was not an indisputable predictor for infection with ESBL-producing E.coli in general practice.
Topics: Adult; Amdinocillin Pivoxil; Anti-Bacterial Agents; Case-Control Studies; Denmark; Escherichia coli; Escherichia coli Infections; Female; General Practice; Humans; Male; Middle Aged; Patient Admission; Penicillin V; Retrospective Studies; Urinary Tract Infections; beta-Lactam Resistance; beta-Lactamases
PubMed: 26523346
DOI: 10.3109/23744235.2015.1103895 -
The Journal of Antimicrobial... Oct 2014
Topics: Amdinocillin Pivoxil; Escherichia coli; Escherichia coli Infections; Female; Humans; Klebsiella Infections; Klebsiella pneumoniae; Male; Urinary Tract Infections; beta-Lactamases
PubMed: 24917584
DOI: 10.1093/jac/dku204