跳至主要内容
临床试验/NCT05960084
NCT05960084尚未招募不适用

Impact of Reducing Colistin Use on Colistin Resistance in Humans and Poultry in Indonesia

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 803 人开始时间: 2023年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
803
试验地点
1
主要终点
Prevalence of mcr-positive E. coli in humans in the community in Central Java, Indonesia

研究概览

简要总结

Colistin (polymyxin E) is considered a last resort antimicrobial for treatment of infections with multidrug- resistant bacteria, classified by WHO as 'highest prioritized, critically important for human medicine'. WHO suggests to ban or highly restrict its use in animals. In Indonesia, colistin resistance in human Escherichia coli isolates is poorly characterized as it requires specific non-routine tests. Presence of colistin resistance in E. coli in poultry resulted in a ban for livestock in Indonesia in 2020. However, colistin is still suspected to be routinely used in humans in multiple settings but the reasons for these practices are poorly understood. The ban on colistin use in livestock offers a unique opportunity to assess the impact of this intervention on colistin resistance in humans and animals, and how a One Health perspective can strengthen this intervention. This project aims to: i) determine phenotypic and genotypic colistin resistance in E. coli from humans and poultry in Indonesia; ii) assess the impact of the colistin ban on resistance in E. coli in animals and humans; iii) estimate the transmission of colistin resistance between animals and humans; iv) study colistin use and perceptions at the community level; and v) expand the initial colistin ban in the animal production sector into an integrative multi-sectorial One Health intervention, which will be designed and implemented using a community participatory approach. This project will provide a strong scientific basis to AMR policies in Indonesia, with great significance across Southeast Asia.

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

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

入选标准

  • All individuals with age >= 18 years old, that are willing to participate

排除标准

  • Vomiting and/or diarrhea

结局指标

主要结局

Prevalence of mcr-positive E. coli in humans in the community in Central Java, Indonesia

时间窗: 2024

Carriage of mcr-1 positive E. coli will be measured by taking rectal swabs of participants for bacterial culture.

Risk factors associated with carriage of mcr-positive E. coli in humans

时间窗: 2024

Interviews based on structured close-ended questionnaires will be used. The questionnaire will include demographic data (gender, age) and possible risk factors (underlying diseases, certain habits as smoking, job, previous antibiotic use).

次要结局

  • Overall antibiotic prescription behaviour in public health centers in Central Java, Indonesia(2024)
  • Transmission of mcr-positive E. coli between farmers and poultry(2024)

研究者

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

Juliëtte Severin

Associate professor, Medical coordinator Unit infection prevention

Erasmus Medical Center

研究点 (1)

Loading locations...

相似试验

Unknown
4 期
Safety and Efficacy Study of High Dose ColistinInfectious Diseases
NCT02162966King Saud Medical City330
Unknown
不适用
Nebulized Colistin for Gram Negative VAP Prevention.Pneumonia, Ventilator-associatedGram-Negative Pneumonia
NCT04208945University of Thessaly152
进行中(未招募)
不适用
Optimizing Dosing of Colistin for Infections Resistant to all Other AntibioticsBloodstream infection (bacteremia) or hospital-acquired pneumonia by Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropenem, piperacillin/tazobactam, ciprofloxacin OR levofloxacinMedDRA version: 12.1Level: LLTClassification code 10060562Term: Bacteremia, unspecifiedMedDRA version: 12.1Level: LLTClassification code 10064977Term: Acinetobacter bacteremiaMedDRA version: 12.1Level: LLTClassification code 10054228Term: Gram-negative bacteremiaMedDRA version: 12.1Level: LLTClassification code 10054279Term: Escherichia coli bacteremiaMedDRA version: 12.1Level: LLTClassification code 10054281Term: Escherichia bacteremiaMedDRA version: 12.1Level: LLTClassification code 10058883Term: Klebsiella bacteremiaMedDRA version: 12.1Level: LLTClassification code 10058884Term: Enterobacter bacteremiaMedDRA version: 12.1Level: LLTClassification code 10058925Term: Serratia bacteremiaMedDRA version: 12.1Level: LLTClassification code 10058926Term: Hemophilus bacteremiaMedDRA version: 12.1Level: LLTClassification code 10058927Term: Pseudomonal bacteremiaMedDRA version: 12.1Level: LLTClassification code 10052596Term: Nosocomial pneumonia
EUCTR2010-021413-23-GRniversity of Athens, Medical School238
已完成
不适用
Colistin Pharmacokinetics in Critically Ill Patients During Extended DialysisInfection Due to Resistant BacteriaAcute Kidney Injury
NCT02556190Hannover Medical School8
Unknown
1 期
Efficacy and Safety of Colistin Based Antibiotic TherapySepticemiaBacterial Infections
NCT04764058Ain Shams University60