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Urinary tract infections in women

Última revisão: 22 Sep 2025
Última atualização: 13 May 2025
13 May 2025

​US FDA approves gepotidacin, a first-in-class antibiotic for UTIs in women

​Gepotidacin has recently been approved by the US Food and Drug Administration (FDA) - the first in a new class of oral antibiotics for adult females with uncomplicated UTIs. This new treatment option is appropriate for uUTIs caused by: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. It has also been approved for use in children ≥12 years of age weighing at least 40 kg.

Gepotidacin is a first-in-class triazaacenaphthylene bacterial type II topoisomerase inhibitor with a novel mechanism of action; inhibiting bacterial DNA replication by blocking two essential topoisomerase enzymes. Mutations in both enzymes would likely be necessary for resistance to occur, raising hopes that the drug will be able to maintain long-term effectiveness and have a lower potential for resistance.

In two randomized clinical trials (EAGLE-2 and EAGLE-3), gepotidacin was noninferior to nitrofurantoin in both studies and superior to nitrofurantoin in EAGLE-3.[88]

Gepotidacin has the potential to cause QTc prolongation, so should be avoided in patients with a history of QTc prolongation, or those with relevant pre-existing cardiac disease, and in patients receiving drugs that prolong the QTc interval. It also should be avoided in patients taking strong CYP3A4 inhibitors, in patients with severe hepatic impairment (Child-Pugh Class C), and in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min).

Urinary tract infections (UTIs) are among the most common conditions encountered by clinicians across a range of settings. The development of gepotidacin marks a major milestone, as it is the first new oral antibiotic for UTIs in more than 20 years. It is anticipated that gepotidacin will be available in the US in the second half of 2025. Gepotidacin has not been approved in Europe as yet.

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Fonte original da atualização

Resumo

Definição

História e exame físico

Principais fatores diagnósticos

  • dysuria
  • urinary frequency
  • hematuria
  • back/flank pain
  • costovertebral angle tenderness
  • fever
Detalhes completos

Outros fatores diagnósticos

  • urinary urgency
  • suprapubic pain and tenderness
Detalhes completos

Fatores de risco

  • sexual activity
  • spermicide use
  • postmenopause
  • positive family history of UTIs
  • history of recurrent UTI
  • presence of a foreign body
  • insulin-treated diabetes
  • high lifetime number of UTIs
  • recent antibiotic use
  • poor bladder emptying
  • increasing age
Detalhes completos

Investigações diagnósticas

Primeiras investigações a serem solicitadas

  • urine dipstick
  • urine microscopy
  • urine culture and sensitivity
Detalhes completos

Investigações a serem consideradas

  • postvoid residual (PVR)
  • renal ultrasound
  • abdominal/pelvic CT scan
  • cystoscopy
Detalhes completos

Algoritmo de tratamento

AGUDA

uncomplicated

complicated suitable for outpatient therapy: not pregnant

complicated suitable for outpatient therapy: pregnant

complicated requiring inpatient therapy: not pregnant

complicated requiring inpatient therapy: pregnant

CONTÍNUA

uncomplicated recurrent (3 or more in 12 months): related to sexual intercourse

uncomplicated recurrent (3 or more in 12 months): unrelated to sexual intercourse

Colaboradores

Autores

Una J. Lee, MD
Una J. Lee

Female Pelvic Medicine and Reconstructive Surgery

Section of Urology and Renal Transplantation

Virginia Mason Medical Center

Seattle

WA

Declarações

UJL declares that she has no competing interests.

Agradecimentos

Dr Una J. Lee would like to gratefully acknowledge Dr Elliot Blau for his contribution to this monograph, and Dr Bhavin N. Patel and Dr Howard B. Goldman, previous contributors to this topic.

Declarações

EB, BNP, and HBG declare that they have no competing interests.

Revisores

Priyanka Sharma, MD

Associate Staff

Cleveland Clinic Foundation

Cleveland

OH

Declarações

PS declares that she has no competing interests.

Timothy J. Benton, MD

Associate Residency Director

Texas Tech University Health Sciences Center

Amarillo

TX

Declarações

TJB declares that he has no competing interests.

Paul Little, BA (Oxon), MBBS, MRCP, MSc, FRCGP, MD

Professor of Primary Care Research

Community Clinical Sciences Division

University of Southampton

Southampton

UK

Declarações

PL declares that he has no competing interests.

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Principais artigos

European Association of Urology. EAU guidelines on urological infections. Mar 2025 [internet publication].Texto completo

Nicolle LE, Gupta K, Bradley SF, et al. Clinical practice guideline for the management of asymptomatic bacteriuria: 2019 update by the Infectious Diseases Society of America. Clin Infect Dis. 2019 Mar 21.Texto completo  Resumo

Bent S, Nallamothu BK, Simel DL, et al. Does this woman have an acute uncomplicated urinary tract infection? JAMA. 2002 May 22-29;287(20):2701-10. Resumo

The American College of Obstetricians and Gynecologists. Urinary tract infections in pregnant individuals. Obstet Gynecol. 2023 Aug 1;142(2):435-45.Texto completo  Resumo

Artigos de referência

Uma lista completa das fontes referenciadas neste tópico está disponível para os usuários com acesso total ao BMJ Best Practice.
  • Diagnósticos diferenciais

    • Asymptomatic bacteriuria
    • Pyelonephritis
    • Urinary tract stones
    Mais Diagnósticos diferenciais
  • Diretrizes

    • Guidelines on urological infections
    • Guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2024 update
    Mais Diretrizes
  • Folhetos informativos para os pacientes

    Cystitis

    Mais Folhetos informativos para os pacientes
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