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临床试验/NCT07393308
NCT07393308尚未招募不适用

Enhancing the Optimization of Empirical Antibiotic Therapy: Development and Implementation of Mobile Antibiograms in Tertiary Hospitals in Tanzania

Muhimbili University of Health and Allied Sciences2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
2
主要终点
Pattern of antibiotic use

研究概览

简要总结

Antimicrobial resistance (AMR) is a critical issue, especially in Africa, with resistance to common antibiotics reaching 100% in some areas. In Tanzania, limited access to culture tests and antibiograms forces healthcare providers to rely on experience for prescribing, heightening AMR risks. This study aims to determine the effectiveness of mobile antibiograms in optimizing empirical antibiotic therapy in tertiary hospitals in Tanzania.

详细描述

A pragmatic quasi-experimental design (hybrid type 1 trial) will be used to evaluate the effectiveness of mobile antibiograms on antibiotic use. The key role of the antibiogram is to guide empirical treatment of symptomatic infections using antibiotics ie., the antibiogram contains a list of susceptible and resistant antibiotics enabling the prescriber to rationally choose the antibiotic which is effective in clearing the infection. The study employs a three-phase, stepwise approach to assess and enhance antimicrobial use in Tanzanian hospitals. The first phase will be a baseline assessment using World Health Organization's Point Prevalence Survey and defined daily dose (DDD) to determine the pattern of antibiotic utilization and consumption respectively. The second phase involves developing a mobile antibiogram application through a participatory design with healthcare stakeholders. The final phase will use a quasi-experimental design to test the effectiveness of the mobile antibiogram on antimicrobial stewardship metrics like DDD per 1000 patient days, antibiotic appropriateness, infection-related mortality and length of hospital stay. The study sites will be Mbeya Zonal Referral Hospital (MZRH) as the intervention group and Benjamini Mkapa Hospital (BMH) as the control group. Additionally, a mixed-methods design (explanatory sequential design) will be used to assess the acceptability, feasibility, and adoption of the mobile antibiograms.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • All prescribers working in the selected tertiary referral hospitals
  • All prescribers owning smartphones
  • Prescribers who consent to take part in the study

排除标准

  • 1. Temporarily employed prescribers

研究组 & 干预措施

standard of care

Active Comparator

Participants will be subjected to manual antibiogram which is the standard of care to guide the empirical prescription of antibiotics

干预措施: standard of care (Other)

Mobile antibiogram

Experimental

Participants will be assigned to the mobile antibiogram application to guide the empirical prescription of antibiotics in addition to standard of care.

干预措施: Mobile antibiogram application (Other)

结局指标

主要结局

Pattern of antibiotic use

时间窗: 12 months

Proportional change in antibiotic use among admitted patients

次要结局

  • Pattern of antibiotic resistance(12 months)
  • Acceptability of mobile antibiograms(12 months)
  • Feasibility of mobile antibiograms(12 months)
  • Adoption of mobile antibiogram(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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