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临床试验/NCT07106944
NCT07106944尚未招募不适用

Extended Tricyle Project Indonesia for Extended-spectrum Beta-lactamase Positive Klebsiella Pneumoniae and Escherichia Coli

Erasmus Medical Center0 个研究点目标入组 100 人开始时间: 2025年8月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Number of pregnant women in the community in Jakarta that carry ESBL-positive E. coli / Klebsiella pneumoniae in their rectum or throat

研究概览

简要总结

In 2019, Indonesia's first WHO Tricycle Project revealed alarming rates of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli across various sectors. The study found ESBL-producing E. coli in 40% of pregnant women, 57.7% of E. coli-induced bloodstream infections, 67.1% of broiler chicken, and 12.8% of total E. coli in water samples. In the first National Action Plan on Antimicrobial Resistance from Indonesia, the reduction of ESBL was identified as a clear goal. In E-Trike, Tricycle will be repeated, using the same methodology, to determine if a reduction has been achieved. Additionally, ESBL-positive Klebsiella pneumoniae will be included, as important pathogen for humans.

详细描述

Antimicrobial resistance (AMR) is a global threat and is considered to be a silent pandemic. It is estimated that in 2021, over 4.71 million deaths were associated with AMR, with 1.14 million attributed to AMR. In 2020, the World Health Organization (WHO) Global Antimicrobial Resistance and Use Surveillance System (GLASS) reported the prevalence of cefotaxime-, ceftriaxone, and ceftazidime-resistant Klebsiella pneumoniae from bloodstream infections in South Asian region was 75.9%, 77.4%, 74.8%, respectively. Based on the report from the Indonesian Society for Clinical Microbiologists in 2023, the prevalence of third-generation cephalosporin-resistant Klebsiella pneumoniae in Indonesia was 57%, while third-generation cephalosporin-resistant E. coli was 68%.

The WHO has been at the forefront of AMR through its Global Surveillance extended-spectrum beta-lactamase (ESBL)-positive E. coli Tricycle Project, which employs a "One Health" approach. This innovative surveillance program aims to obtain a comprehensive picture of AMR in humans, animals, and the environment, particularly in countries with limited surveillance capabilities. Indonesia's first pilot Tricycle Project revealed alarming rates of ESBL-producing E. coli across various sectors. The study found ESBL-producing E. coli in 40% of pregnant women, 57.7% of E. coli-induced bloodstream infections, 67.1% of broiler chicken, and 12.8% of total E. coli in water samples. These findings underscore the worrisome pattern of AMR in Indonesia and highlight the urgent need for expanded surveillance and control strategies.

Klebsiella pneumoniae is the second most common Enterobacterales found in humans; its role in animals and the environment is less clear, even more in the Indonesian setting. A better understanding of the presence of this human pathogen in other domains is needed, so that effective intervention strategies on AMR for the Indonesian situation can be designed.

In E-Trike, the original WHO Tricycle protocol (which already includes sample size calculation) will be used, with three modifications:

  1. ESBL-K. pneumoniae (ESBL-Kp) will be included for all samples. Additionally, from pregnant women, not only rectal samples will be taken, but also throat samples, as previously it was shown that 15% of adults carry Kp in their throat in Indonesia.
  2. In addition to the MacConkey agar supplemented with cefotaxime, CHROMagar plates will be used.
  3. The sampling period will only be 5 months, instead of the 10 months that was used in the 2019 Tricycle. However, both "wet" and "dry" months will be included.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • pregnant women at antenatal visits

排除标准

  • no informed consent

结局指标

主要结局

Number of pregnant women in the community in Jakarta that carry ESBL-positive E. coli / Klebsiella pneumoniae in their rectum or throat

时间窗: July 2025-March 2026

Number of ESBL-positive E. coli/K. pneumoniae among all blood cultures taken / all E. coli/K. pneumoniae from blood cultures

时间窗: July 2025 - March 2026

Prevalence of ESBL-Ec and ESBL-Kp in the food chain (chicken) in Jakarta, Indonesia

时间窗: July 2025 - March 2026

Prevalence of ESBL-Ec and ESBL-Kp in the environment (water) in Jakarta, Indonesia

时间窗: July 2025 - March 2026

次要结局

  • Number of ESBL-Ec and ESBL-Kp ("yield") found using the ESBL Chromagar™ plate compared to the MacConkey agar plate supplemented with 4 mg/L cefotaxime per human subject or chicken or environmental sample included.(July 2025-March 2026)
  • Number of ESBL-Ec and ESBL-Kp found in the study with resistance to carbapenem antibiotics and other relevant classes of antibiotic.(July 2025 - March 2026)
  • The prevalence of ESBL resistant genes among the ESBL-Ec and ESBL-Kp isolates found in the study based on genomic analysis.(July 2025-March 2026)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juliëtte Severin

Associate professor, MD PhD

Erasmus Medical Center

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