Archive for January 15, 2016

Ceftolozane/Tazobactam Plus Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results From a Randomized, Double-Blind, Phase 3 Trial (ASPECT-cIAI).

Clin Infect Dis. 2015 May 15;60(10):1462-71.

Solomkin J1, Hershberger E2, Miller B2, Popejoy M2, Friedland I2, Steenbergen J2, Yoon M2, Collins S2, Yuan G2, Barie PS3, Eckmann C4.

Author information

1Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.

2Cubist Pharmaceuticals, Lexington, Massachusetts.

3Departments of Surgery and Medicine, Weill Cornell Medical College, New York, New York.

4Department of General, Visceral and Thoracic Surgery, Academic Hospital of Medical University Hannover, Peine, Germany.

Abstract

BACKGROUND:

Increasing antimicrobial resistance among pathogens causing complicated intra-abdominal infections (cIAIs) supports the development of new antimicrobials. Ceftolozane/tazobactam, a novel antimicrobial therapy, is active against multidrug-resistant Pseudomonas aeruginosa and most extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae.

METHODS:

ASPECT-cIAI (Assessment of the Safety Profile and Efficacy of Ceftolozane/Tazobactam in Complicated Intra-abdominal Infections) was a prospective, randomized, double-blind trial. Hospitalized patients with cIAI received either ceftolozane/tazobactam (1.5 g) plus metronidazole (500 mg) every 8 hours or meropenem (1 g) every 8 hours intravenously for 4-14 days. The prospectively defined objectives were to demonstrate statistical noninferiority in clinical cure rates at the test-of-cure visit (24-32 days from start of therapy) in the microbiological intent-to-treat (primary) and microbiologically evaluable (secondary) populations using a noninferiority margin of 10%. Microbiological outcomes and safety were also evaluated.

RESULTS:

Ceftolozane/tazobactam plus metronidazole was noninferior to meropenem in the primary (83.0% [323/389] vs 87.3% [364/417]; weighted difference, -4.2%; 95% confidence interval [CI], -8.91 to .54) and secondary (94.2% [259/275] vs 94.7% [304/321]; weighted difference, -1.0%; 95% CI, -4.52 to 2.59) endpoints, meeting the prespecified noninferiority margin. In patients with ESBL-producing Enterobacteriaceae, clinical cure rates were 95.8% (23/24) and 88.5% (23/26) in the ceftolozane/tazobactam plus metronidazole and meropenem groups, respectively, and 100% (13/13) and 72.7% (8/11) in patients with CTX-M-14/15 ESBLs. The frequency of adverse events (AEs) was similar in both treatment groups (44.0% vs 42.7%); the most common AEs in either group were nausea and diarrhea.

CONCLUSIONS:

Treatment with ceftolozane/tazobactam plus metronidazole was noninferior to meropenem in adult patients with cIAI, including infections caused by multidrug-resistant pathogens.

CLINICAL TRIALS REGISTRATION: NCT01445665 and NCT01445678.

PDF

http://cid.oxfordjournals.org/content/60/10/1462.full.pdf

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January 15, 2016 at 9:09 am

Ceftolozane/Tazobactam: a new option in the treatment of complicated gram-negative infections.

P T. 2014 Dec;39(12):825-32.

Sorbera M, Chung E, Ho CW, Marzella N.

Abstract

Ceftolozane/tazobactam: a new option in the treatment of complicated gram-negative infections.

PDF

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264669/pdf/ptj3912825.pdf

January 15, 2016 at 9:08 am

Antimicrobial activity of ceftolozane/tazobactam tested against Pseudomonas aeruginosa and Enterobacteriaceae with various resistance patterns isolated in European hospitals (2011-12).

J Antimicrob Chemother. 2014 Oct;69(10):2713-22.

Sader HS1, Farrell DJ2, Castanheira M2, Flamm RK2, Jones RN2.

Author information

1JMI Laboratories, North Liberty, IA 52317, USA helio-sader@jmilabs.com

2JMI Laboratories, North Liberty, IA 52317, USA.

Abstract

OBJECTIVES:

To evaluate the in vitro activity of ceftolozane/tazobactam and comparator agents tested against contemporary Gram-negative bacteria. Ceftolozane/tazobactam is an antipseudomonal cephalosporin combined with a well-established β-lactamase inhibitor.

METHODS:

A total of 10 532 Gram-negative organisms (2191 Pseudomonas aeruginosa and 8341 Enterobacteriaceae) were consecutively collected from 31 medical centres located in 13 European countries plus Turkey and Israel. The organisms were tested for susceptibility by broth microdilution methods as described by the CLSI M07-A9 document and the results interpreted according to EUCAST as well as CLSI breakpoint criteria. Selected ceftazidime- and/or meropenem-resistant P. aeruginosa isolates were screened for the presence of β-lactamase genes by PCR.

RESULTS:

P. aeruginosa exhibited high rates of multidrug-resistant (31.9%) and extensively drug-resistant (24.6%) isolates and 11.6% of isolates were susceptible only to colistin. When tested against P. aeruginosa, ceftolozane/tazobactam (MIC(50), 1 mg/L) was generally 4-fold more active than ceftazidime (MIC(50), 4 mg/L) and inhibited >90% of isolates with an MIC of ≤8 mg/L in nine countries. In contrast, the highest susceptibility rates observed for ceftazidime and meropenem, respectively, were 86.0%/86.0% (UK) and 85.2%/86.1% (Ireland) (67.2%/67.1% overall). Ceftolozane/tazobactam (MIC(50/90), 0.25/2 mg/L; 93.7% and 95.2% inhibited at ≤4 and ≤8 mg/L, respectively), meropenem [MIC(50/90), ≤0.06/≤0.06 mg/L; 98.0% susceptible (EUCAST)] and tigecycline [MIC(50/90), 0.12/1 mg/L; 94.1% susceptible (EUCAST)] were the most active compounds tested against Enterobacteriaceae.

CONCLUSIONS:

Ceftolozane/tazobactam was the most active β-lactam agent tested against P. aeruginosa and demonstrated higher in vitro activity than currently available cephalosporins and piperacillin/tazobactam when tested against Enterobacteriaceae.

PDF

http://jac.oxfordjournals.org/content/69/10/2713.full.pdf

January 15, 2016 at 9:07 am

Urinary tract infections in pregnancy: old and new unresolved diagnostic and therapeutic problems.

Arch Med Sci. 2015 Mar 16;11(1):67-77.

Matuszkiewicz-Rowińska J1, Małyszko J2, Wieliczko M1.

Author information

1Chair and Clinic of Nephrology, Dialysis and Internal Diseases, Medical University of Warsaw, Warsaw, Poland.

2Department of Nephrology and Transplantation, Medical University of Bialystok, Bialystok, Poland.

Abstract

Urinary tract infections (UTIs) are common in pregnant women and pose a great therapeutic challenge, since the risk of serious complications in both the mother and her child is high.

Pregnancy is a state associated with physiological, structural and functional urinary tract changes which promote ascending infections from the urethra.

Unlike the general population, all pregnant women should be screened for bacteriuria with urine culture, and asymptomatic bacteriuria must be treated in every case that is diagnosed, as it is an important risk factor for pyelonephritis in this population. The antibiotic chosen should have a good maternal and fetal safety profile.

In this paper, current principles of diagnosis and management of UTI in pregnancy are reviewed, and the main problems and controversies are identified and discussed.

PDF

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4379362/pdf/AMS-11-21873.pdf

January 15, 2016 at 9:03 am

Impact of genital hygiene and sexual activity on urinary tract infection during pregnancy.

Urol Ann. 2015 Oct-Dec;7(4):478-81.

Badran YA1, El-Kashef TA1, Abdelaziz AS2, Ali MM1.

Author information

1Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.

2Department of Urology, Military Hospitals, Cairo, Egypt.

Abstract

INTRODUCTION:

Urinary tract infection (UTI) is a bacterial infection commonly occurring during pregnancy. The incidence of UTI in pregnant women depends on parity, race, and socioeconomic status and can be as high as 8%.

OBJECTIVE:

The objective was to determine the association of UTI with genital hygiene practices and sexual activity in pregnant women.

PATIENTS AND METHODS:

From January 2011 to June 2014, a total of 200 pregnant women attending prenatal clinics in Al-Zahra Hospital and King Khalid Hospital in Saudia Arabia Kingdom were selected. Eighty pregnant women, who had positive urine cultures (cases), were compared with the remaining 120 healthy pregnant women matched for age, social, economic and education status, and parity (controls).

RESULTS:

In the present work, Escherichia coli were the infecting organism in 83% of cases. Factors associated with UTI included sexual intercourse ≥ 3 times/week (odds ratio [OR] =5.62), recent UTI (OR = 3.27), not washing genitals precoitus (OR = 2.16), not washing genitals postcoitus (OR = 2.89), not voiding urine postcoitus (OR = 8.62) and washing genitals from back to front (OR = 2.96) [OR = odds ratio].

CONCLUSION:

Urinary tract infection in pregnant women was primarily caused by bacteria from the stool (E. coli) and that hygiene habits, and sexual behavior may play a role in UTI in pregnant women.

FULL TEXT

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4660700/

January 15, 2016 at 9:02 am


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