Fixed-dose combination ceftolozane / tazobactam (Zerbaxa) for the treatment of complicated urinary tract infections and acute pyelonephritis

Introduction

The fixed-dose combination of ceftolozane and tazobactam (trade name: Zerbaxa) has been approved in Germany since September 2015 for the treatment of complicated urinary tract infections in adults. This fixed-dose combination has also been approved for the treatment of acute ( of the kidney).

Urinary tract infections (UTIs) and acute are both inflammations of the urinary tract. A urinary tract is normally caused by bacteria that get into the urethra (the tube that urine leaves the body through) and then enter the bladder. Pyelonephritis may be caused by moving further up into the kidneys through the ureters (the tubes between the bladder and kidneys).

A complicated urinary tract is a UTI that is associated with a high risk of complications. People who have a high risk of complications include people who have a weakened or damaged kidneys, as well as men who have a UTI. Changes or anatomical abnormalities along the urinary tract may increase the likelihood of complications too. The is also considered to be complicated if there is a greater risk of the infection spreading to the kidneys.

The typical symptoms of a lower urinary tract include an increased urge to urinate (pee) and painful urination. Pyelonephritis may also cause fever, pain near the kidneys (flank pain), nausea and vomiting.

Urinary tract infections and acute are treated with .

The fixed dose combination of ceftolozane / tazobactam is an antibiotic: Ceftolozane kills the , and tazobactam enhances the effect by attacking an enzyme that would otherwise make ceftolozane inactive.

Application

The fixed-dose combination of ceftolozane / tazobactam is given every 8 hours in the form of an infusion into the bloodstream (IV drip). The dose for complicated urinary tract infections and acute is 1 g ceftolozane and 0.5 g tazobactam. The treatment is usually stopped after 7 days.

The dose is lowered in patients with moderately to severely impaired kidney function or terminal kidney failure.

Other treatments

Adults who have a complicated urinary tract or acute can have individualized treatment with . Individualized antibiotic treatment takes into account the local presence of germs, (local) resistances to , the risk of by multiresistant , and the sensitivity of the to .

Assessment

In 2020, researchers from the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assessed whether the fixed-dose combination of ceftolozane / tazobactam has any advantages or disadvantages compared to the standard treatment for

  • complicated urinary tract infections or
  • acute

in adults.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of the fixed-dose combination of ceftolozane / tazobactam (Zerbaxa) for the treatment of complicated urinary tract infections and acute pyelonephritis.

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ceftolozane/tazobactam (complicated urinary tract infections) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-28. June 29, 2020. (IQWiG reports; Volume 939).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ceftolozane/tazobactam (acute pyelonephritis) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-29. June 29, 2020. (IQWiG reports; Volume 940).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on July 16, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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