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Not yet recruiting NCT07393308

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

No phase Interventional Antimicrobial Prescribing Practices Antimicrobial Resistance (AMR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile antibiogram application, standard of care.
Who it may be relevant to
Registry conditions: Antimicrobial Prescribing Practices, Antimicrobial Resistance (AMR). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tanzania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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.
  • Other standard of care
    Participants will be assigned to manual antibiogram only.

Primary outcome measures

  • Pattern of antibiotic use [Time frame: 12 months]
Secondary outcome measures (4)
  • Pattern of antibiotic resistance [Time frame: 12 months]
  • Acceptability of mobile antibiograms [Time frame: 12 months]
  • Feasibility of mobile antibiograms [Time frame: 12 months]
  • Adoption of mobile antibiogram [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

1\. Temporarily employed prescribers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

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

Publications

  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗