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临床试验/NCT03218800
NCT03218800终止3 期

Ertapenem Administered Subcutaneously Versus Intravenously for Urinary Tract Infections in Oncological Palliative Care Patients: a Randomized, Open, Non-inferiority Clinical Trial

Instituto Nacional de Cancer, Brazil2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
3 期
状态
终止
发起方
入组人数
30
试验地点
2
主要终点
microbiological cure

研究概览

简要总结

Infections requiring intravenous antimicrobial therapy are very common events in patients with advanced cancer. Nevertheless, these patients frequently present vascular damages becoming extremely difficult to access and maintain intravenous route for hydration and nutritional support. In this context, the subcutaneous route could be implemented as an alternative route for replacement of fluids, electrolytes and drugs. Few studies have evaluated the possibility of using the subcutaneous route for treatment of infections though.

Patients in palliative care often have infections caused by multidrug resistant bacterial such as beta-lactamase producing bacteria. In this context, we hypothesize Ertapenem subcutaneously is not inferior to the same drug intravenously for the treatment of urinary infections in patients on oncologic palliative care. A non-inferiority clinical trial would be adequate and could provide stronger evidence on the possibility of this alternative route for antibiotic therapy in urinary tract infections, with important advantages such as greater convenience of use.

详细描述

This is a randomized open label clinical trial to evaluate Ertapenem administered subcutaneously is non-inferior to the same antibiotic intravenously to treat urinary tract infections in oncological palliative care patients.

The study will be performed at the Palliative Care Unit (PCU) of the National Cancer Institute of Brazil José Alencar Gomes da Silva (INCA), a 56-bed hospital and the only public hospital for cancer palliative care located in the city of Rio de Janeiro, Brazil.

A sample of 82 patients was estimated, considering the level of significance (alpha) of unilateral 2.5%, the power of the study (1-beta) of 80%, the non-inferiority limit of 4%, and success percentages in the groups control and experimental studies of 92% and 100%, respectively. Once the high mortality rate of the study site (about 60%, according to unpublished administrative information), it was decided to increase this number by 30% to compensate for possible losses, totaling 106 patients, 53 in each arm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any type of cancer in palliative care;
  • Urinary tract infection;
  • Informed consent assigned by the patient or legal representative.

排除标准

  • Neutropenia;
  • Unconsciousness.

结局指标

主要结局

microbiological cure

时间窗: seven days for cystitis and fourteen days for pyelonephritis

negative uroculture at the end of the treatment

次要结局

  • adverse events(30 days)
  • clinical response(14 days)

研究者

发起方
Instituto Nacional de Cancer, Brazil
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Luciana Ramadas

MD

Instituto Nacional de Cancer, Brazil

研究点 (2)

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