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Набор скоро начнётся NCT07393308

Development and Implementation of Mobile Antibiograms to Optimize Empirical Antibiotic Prescriptions Among Prescribers in Tertiary Hospitals in Tanzania

Без фазы С лечением Antimicrobial Prescribing Practices Antimicrobial Resistance (AMR)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mobile antibiogram application, standard of care.
Кому может быть актуально
Состояния в реестре: Antimicrobial Prescribing Practices, Antimicrobial Resistance (AMR). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Tanzania
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Mobile antibiogram application
    A mobile antibiogram application software containing antibiotic sensitivity test results specific to the health facility. This mobile antibiogram application will guide decision support for empirical prescription.
  • Другое standard of care
    Participants will be assigned to manual antibiogram only.

Первичные конечные точки

  • Pattern of antibiotic use [Срок оценки: 12 months]
Вторичные конечные точки (4)
  • Pattern of antibiotic resistance [Срок оценки: 12 months]
  • Acceptability of mobile antibiograms [Срок оценки: 12 months]
  • Feasibility of mobile antibiograms [Срок оценки: 12 months]
  • Adoption of mobile antibiogram [Срок оценки: 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

1\. Temporarily employed prescribers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Tanzania · 2 центра
  • Benjamin Mkapa Hospital — Dodoma
  • Mbeya Zonal Referral Hospital — Mbeya

Публикации

  • Zimbwe KB, Yona YJ, Chiwambo CA, Chandika AB, Kiwelu HS, Shabani MM. Trends and patterns of antimicrobial consumption at Benjamin Mkapa Zonal Referral Hospital, Dodoma, Tanzania: a cross-sectional retrospective analysis. BMJ Open. 2024 Nov 13;14(11):e083842. doi: 10.1136/bmjopen-2023-083842. PMID 39537568
  • Nsojo A, Mbotwa C, Rweyemamu L, Mbwanji G, Wilson F, George L, Mwasomola D, Mweya CN, Mwakyula I. In vitro performance of cost differentiated ceftriaxone brands against Escherichia coli: insights from a tertiary referral hospital in Mbeya, Tanzania. JAC Antimicrob Resist. 2024 Oct 14;6(5):dlae162. doi: 10.1093/jacamr/dlae162. eCollection 2024 Oct. PMID 39403674
  • Mutagonda RF, Marealle AI, Nkinda L, Kibwana U, Maganda BA, Njiro BJ, Ndumwa HP, Kilonzi M, Mikomangwa WP, Mlyuka HJ, Felix FF, Myemba DT, Mwakawanga DL, Sambayi G, Kunambi PP, Ndayishimiye P, Sirili N, Mfaume R, Nshau A, Nyankesha E, Scherpbier R, Bwire GM. Determinants of misuse of antibiotics among parents of children attending clinics in regional referral hospitals in Tanzania. Sci Rep. 2022 M PMID 35318386
  • Minzi OM, Kilonzi M, Mikomangwa WP, Bwire GM, Myemba DT, Marealle AI, Mlyuka HJ, Kibanga W, Mutagonda RF, Mwambete K. Update on bacterial and antibiotic susceptibility profiles among patients attending a tertiary referral hospital in Tanzania. J Glob Antimicrob Resist. 2021 Jun;25:87-88. doi: 10.1016/j.jgar.2021.02.030. Epub 2021 Mar 13. No abstract available. PMID 33727206
  • Nkinda L, Mwakawanga DL, Kibwana UO, Mikomangwa WP, Myemba DT, Sirili N, Mwakalukwa R, Kilonzi M, Sambayi G, Maganda BA, Njiro BJ, Ndumwa HP, Mutagonda R, Marealle AI, Felix FF, Mlyuka HJ, Makuka G, Kubigwa SW, Kunambi PP, Mfaume R, Nshau AB, Bwire GM, Scherpbier R, Nyankesha E. Implementation of antibiotic stewardship programmes in paediatric patients in regional referral hospitals in Tanzania: e PMID 36439992
  • Zimbwe KB, Yona YJ, Chiwambo CA, Chandika AB, Kiwelu HS, Kizenga OS, Mleke MM, Shabani MM. Surveillance of antibiotics use in inpatients at Benjamin Mkapa Zonal Referral Hospital in Dodoma, Tanzania: a point prevalence survey. BMJ Open. 2024 Aug 3;14(8):e083444. doi: 10.1136/bmjopen-2023-083444. PMID 39097319
  • Sangeda RZ, Kibona J, Munishi C, Arabi F, Manyanga VP, Mwambete KD, Horumpende PG. Assessment of Implementation of Antimicrobial Resistance Surveillance and Antimicrobial Stewardship Programs in Tanzanian Health Facilities a Year After Launch of the National Action Plan. Front Public Health. 2020 Aug 27;8:454. doi: 10.3389/fpubh.2020.00454. eCollection 2020. PMID 32974264
  • Nkinda L, Kilonzi M, Felix FF, Mutagonda R, Myemba DT, Mwakawanga DL, Kibwana U, Njiro BJ, Ndumwa HP, Mwakalukwa R, Makuka G, Kubigwa SW, Marealle AI, Mikomangwa WP, Sambayi G, Kunambi PP, Maganda BA, Sirili N, Mfaume R, Nshau AB, Bwire GM, Scherpbier R, Nyankesha E, Ndayishimiye P. Drivers of irrational use of antibiotics among children: a mixed-method study among prescribers and dispensers in Ta PMID 35902955

Идентификаторы

NCT: NCT07393308 · MUHAS-REC-10-2025-3152 · 224127

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗