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O estudo clínico NCT07236944 (PIVOT) para Febrile Urinary Tract Infection está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care (PIVOT) Fase IV 560 Microbioma Randomizado

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07236944 (PIVOT) procura avaliar tratamento para Febrile Urinary Tract Infection. Este é um estudo intervencionista de Fase IV. Seu status atual é: em recrutamento. O estudo começou em 1 de dezembro de 2025 e pretende incluir 560 participantes. Coordenado por a Universidade de Uppsala e deve ser concluído em 1 de março de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 17 de dezembro de 2025.
Resumo
The goal of this clinical trial is to learn if oral treatment with pivmecillinam is effective to treat febrile urinary tract infections in adult patients. Hospitalized patients who have received 2-4 days of intravenous antibiotic therapy for febrile urinary tract infections, and have responded to treatment, will be randomized to either pivmecillinam or standard treatment (other oral or intravenous antibiotics).

The ...

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Descrição detalhada
Background:

Escherichia coli is the predominant uropathogen and the most common cause of bloodstream infections. In the hospital setting, patients with febrile UTI (fUTI) are normally treated with intravenous antibiotics for 2-4 days until clinical improvement followed by oral step-down treatment guided by microbiological antibiotic susceptibility testing results. However, oral treatment options are increasingly lim...

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Título oficial

Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care: A Randomized Controlled Non-Inferiority Multicenter Trial

Condições médicas
Febrile Urinary Tract Infection
Outros IDs do estudo
  • PIVOT
  • 2023-503447-33-00 (Número CTIS (UE))
Número NCT
NCT07236944
Data de início (real)
2025-12
Última atualização postada
2025-12-17
Data de conclusão (estimada)
2029-03
Inscrição (estimada)
560
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Em recrutamento
Palavras-chave
Urinary Tract Infection
Pivmecillinam
Escherichia coli
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Comparador ativoStandard of care
The control group will receive standard of care treatment at the discretion of the responsible physician and according to existing treatment guidelines.
Standard of Care (Investigator Choice)
The control group will receive standard of care antibiotic treatment at the discretion of the responsible physician and according to existing treatment guidelines, with a total treatment duration of 7 to 14 days. The following antibiotics will be considered adequate. Intravenous antibiotics: 1) Penicillins; ampicillin, piperacillin/tazobactam, 2) cephalosporins; cefotaxime, cefuroxime, ceftriaxone, 3) carbapenems; er...Mostrar mais
ExperimentalPivmecillinam
Pivmecillinam (high dose, 400 mg four times daily).
Pivmecillinam
Patients randomized to pivmecillinam will be provided with 400 mg tablets for 3 to 8 days of treatment, to be taken four times daily, resulting in a total treatment duration of 7 or 10 days (including the initial 2-4 days of intravenous treatment). The shorter treatment duration of 7 days will be used for female patients with no complicating factors (structural or functional urologic abnormalities, urinary tract cath...Mostrar mais
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Clinical response (primary endpoint).
Clinical response: i) no new healthcare contacts or antibiotic treatments for suspected or proven UTI, ii) sustained defervescence (\< 38°C), and iii) patient-documented resolution of fUTI symptoms that were present and recorded in the eCRF at trial entry (and no new fUTI symptoms) at test of cure (TOC), which will be performed 7 (+/-2) days after end of treatment (EOT). The evaluation of clinical response (primary endpoint) will be performed by blinded assessors.
7 (+/-2) days after EOT
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Sustained clinical response
Sustained clinical response: i) no new healthcare contacts or antibiotic treatments for suspected or proven UTI, ii) no recurrent fever (≥ 38°C), and iii) no recurrent UTI symptoms after completion of the initial therapy and until 28 (+/- 2) days after EOT.
28 (+/- 2) days after EOT
Microbiological response
Microbiological response: no detectable growth of E. coli in urine sampled at TOC, i.e., 7 (+/-2) days after EOT.
7 (+/-2) days after EOT
Sustained microbiological response
Sustained microbiological response: no detectable growth of E. coli in urine sampled at the second follow-up 28 (+/- 2) days after EOT.
28 (+/- 2) days after EOT
Occurrence and severity of adverse events
Occurrence and severity of adverse events from start of study treatment until TOC; recorded by the participants in a study diary, documented in the medical records, or reported at the TOC follow-up.
From start of study treatment until test of cure 7 (+/-2) days after EOT
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  1. ≥18 years of age.
  2. Diagnosis of fUTI, defined as i) fever ≥ 38°C and ii) at least one of the following: flank pain or pelvic pain, nausea or vomiting, dysuria, urinary frequency or urgency, and costovertebral angle tenderness on physical examination.
  3. Growth of E. coli in urine with antimicrobial susceptibility to mecillinam.
  4. Adequate intravenous antibiotic treatment for fUTI (defined below) for 2 days to which the isolated E. coli is determined susceptible.
  5. Defervescence and hemodynamic stability for at least 24 hours, according to the responsible physician.
  6. Planned treatment with one of the following antibiotics, should the patient be randomized to the standard-of-care arm. Intravenous antibiotics: 1) Penicillins; ampicillin, piperacillin/tazobactam, ≥2) cephalosporins; cefotaxime, cefuroxime, ceftriaxone, 3) carbapenems; ertapenem, imipenem, meropenem, 4) monobactams; aztreonam, 5) aminoglycosides; amikacin, gentamicin, tobramycin, 6) other; fosfomycin. Oral antibiotics: 1) ciprofloxacin, 2) trimethoprim-sulfamethoxazole, 3) amoxicillin or amoxicillin/clavulanic acid provided that the isolated E. coli is determined susceptible according to the EUCAST-breakpoint for systemic infections, i.e., MIC ≤ 8 mg/l, and high dosing is used (≥750 mg amoxicillin x 3 and ≥750 mg amoxicillin/125 mg clavulanic acid x 3, respectively) and 4) tebipenem (if approved by the EMA).
  7. Signed informed consent.

  1. Adequate intravenous antibiotic treatment for > 4 days prior to randomization or other adequate (microbiologically active) oral antibiotic treatment for the same fUTI episode prior to recruitment.
  2. Growth of other bacterial species than E. coli, or fungi, in urine.
  3. Contraindication for pivmecillinam (e.g. allergy).
  4. Clinical suspicion of bacterial prostatitis.
  5. Renal abscess.
  6. Kidney transplant.
  7. Myelosuppressive disorder with neutrophil count < 0.5 x 10(9)/L at randomization.
  8. Planned antibiotic treatment for fUTI > 14 days.
  9. Likely to be prescribed antibiotic prophylaxis after treatment.
  10. Other intravenous or oral antibiotic treatment; ongoing or planned during the follow-up period (i.e. until 28 days after EOT for fUTI).
  11. Severe renal impairment (eGFR < 20 mL/min) at randomization.
  12. Morbid obesity (BMI > 40 kg/m2).
  13. Pregnancy or breastfeeding.
  14. Unlikely to follow instructions or the study protocol.
  15. Previous participation in the study.
  16. If consenting to microbiome analysis: i) contraindication for ciprofloxacin (e.g. allergy), ii) unlikely to be able to provide fecal samples per protocol, iii) treatment with antibiotics in the past 3 months before the current fUTI episode, iv) chronic intestinal disease or previous surgery in the gastrointestinal tract.
  17. If consenting to pharmacokinetic analysis: expected difficulties in providing blood and urine samples per protocol.
Uppsala University logoUniversidade de Uppsala
  • The Swedish Research Council logoThe Swedish Research Council
  • Uppsala Clinical Research Center, Sweden logoUppsala Clinical Research Center, Sweden
Contato central do estudo
Contato: Thomas Tängdén, MD, Professor, +46 708 370323, [email protected]
Contato: Lisa Faxén, MD, PhD student, +46 768 721806, [email protected]
13 Locais do estudo em 2 países
Haukeland University Hospital, Haukeland, Norway
Eivind Rath, MD, PhD, Contato, [email protected]
Ainda não recrutando
Oslo University Hospital, Oslo, Norway
Kristian Tonby, MD, Associate professor, Contato, [email protected]
Ainda não recrutando
Södra Älvsborg Hospital, Borås, Sweden
Anders Lundqvist, MD, PhD, Contato, [email protected]
Ainda não recrutando
Eskilstuna Hospital, Eskilstuna, Sweden
Joakim Lundvik, MD, Contato, [email protected]
Ainda não recrutando
Sahlgrenska University Hospital, Gothenburg, Sweden
Erik Sörstedt, MD, PhD, Contato, [email protected]
Hanna Montelin, MD, PhD, Contato, [email protected]
Em recrutamento
Blekinge Hospital, Karlskrona, Sweden
Eva Lindqvist, MD, Contato, [email protected]
Ainda não recrutando
Skåne University Hospital, Lund, Sweden
Christian Kampmann, MD, PhD, Contato, [email protected]
Ainda não recrutando
Örebro University Hospital, Örebro, Sweden
Edvin Ingberg, MD, PhD, Contato, [email protected]
Em recrutamento
Karolinska University Hospital, Stockholm, Sweden
Pontus Nauclér, MD, Professor, Contato, [email protected]
Ainda não recrutando
Sundsvall Hospital, Sundsvall, Sweden
Björn Diedrichs, MD, Contato, [email protected]
Ainda não recrutando
Umeå University Hospital, Umeå, Sweden
Urban Johansson Kostenniemi, MD, PhD, Contato, [email protected]
Ainda não recrutando
Uppsala University Hospital, Uppsala, Sweden
Thomas Tängdén, MD, Professor, Contato, + 46 708370323, [email protected]
Lisa Faxén, MD, PhD student, Contato, +46 768 72 18 06, [email protected]
Em recrutamento
Central Hospital Växjö, Vaxjo, Sweden
Olof Elvstam, MD, PhD, Contato, [email protected]
Ainda não recrutando