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临床试验/CTRI/2025/10/095840
CTRI/2025/10/095840尚未招募不适用

Development of Customized Antimicrobial Stewardship Program for Rural Hospitals using Hub and Spoke model in districts of West Bengal -a health system implementation research.

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 3,132 人开始时间: 2025年11月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,132
试验地点
1
主要终点
3.Parenteral antibiotics prescribing rate (PAPR) - number of prescriptions that included at one injectable antibiotic /total number of prescriptions that included at least one antibiotic × 100.

研究概览

简要总结

Rationale:

Primary care health facilities do not have microbiological diagnostic services and neither any antimicrobial stewardship programs (AMSP) yet a huge proportion of rural population takes empirical antibiotic from these settings.

Novelty: Novelty lies in its approach to establish customized AMSP in Rural Hospitals by linking it to  District Medical Colleges through Hub and Spoke Model.

 Objectives:

Primary objectives:

  1. To generate the baseline data in terms of key AMSP indicators in selected rural hospitals (RH) of two districts of West Bengal

  2. To develop and implement customized AMSP intervention in selected RH through the Hub and Spoke Model

  3. To evaluate the effectiveness of customized AMSP intervention in RH against control Arm (existing system in RH)

 Secondary objective:

1 To identify barriers & facilitators of customized AMSP intervention through Hub and Spoke Model.

Methods: In this Health System Implementation Research through two arm cluster randomized intervention, 6 Rural Hospitals will be selected from 2 districts each (Total 12 RH). 3 RH in each districts will be termed as intervention arm and linked to Medical Colleges and remaining will be control arm.(Standard Practice). Package of AMSP Intervention will include formulation of committee, periodic training of Physician, Nurses, culture and antibiogram, use of point of care test etc. Prescriptions will be evaluated pre and post intervention (1 year) for its effectiveness in terms rational antibiotic prescription indicators.

Expected outcome:

  1. Determining the effectiveness of customized AMSP interventions through Hub and Spoke model for rationalizing antibiotic usage in primary care settings.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Diseases as follows: Acute Undifferentiated Febrile illness, Urinary Tract Infection, Acute Respiratory Infections, Acute Diarrhoeal Disaeses.

排除标准

  • Unable or Unwilling to provide consent.

结局指标

主要结局

3.Parenteral antibiotics prescribing rate (PAPR) - number of prescriptions that included at one injectable antibiotic /total number of prescriptions that included at least one antibiotic × 100.

时间窗: Pre and Post intervention

(European Surveillance of Antibiotic Consumption)

时间窗: Pre and Post intervention

4.Antibiotic prescribed as per WHO AWaRe classification - Access to Watch Ratio

时间窗: Pre and Post intervention

Indicators:

时间窗: Pre and Post intervention

. 1.Antibiotic prescribing rate (APR) - number of prescriptions that included at least one antibiotic/total number of prescriptions × 100

时间窗: Pre and Post intervention

2. Multiple antibiotics prescribing rate (MPR ) - number of prescriptions that included at least two antibiotics /total number of prescriptions that included at least one antibiotic × 100.

时间窗: Pre and Post intervention

次要结局

  • The difference in DDD per 1000 inpatient days (ATC-DDD)(Pre and Post intervention)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Debjit Chakraborty

ICMR - National Institute for Research in Bacterial Infections

研究点 (1)

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