- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07393308
Development and Implementation of Mobile Antibiograms to Optimize Empirical Antibiotic Prescriptions Among Prescribers in Tertiary Hospitals in Tanzania (AMR; AMU; DDD)
January 30, 2026 updated by: Muhimbili University of Health and Allied Sciences
Enhancing the Optimization of Empirical Antibiotic Therapy: Development and Implementation of Mobile Antibiograms in Tertiary Hospitals in Tanzania
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alphonce Ignace Marealle, PhD
- Phone Number: +255713629365
- Email: marealle2010@gmail.com
Study Contact Backup
- Name: Wigilya Padili Mikomangwa, MSc
- Email: wpad.miko@gmail.com
Study Locations
-
-
-
Dodoma, Tanzania
- Benjamin Mkapa Hospital
-
Contact:
- Farida Khalifa Mbura, Microbiology and Immunology
- Email: faridambura1975@gmail.com
-
Mbeya, Tanzania
- Mbeya Zonal Referral Hospital
-
Contact:
- Anthony A Nsojo, MD; MMED
- Email: ansojo43@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: standard of care
Participants will be subjected to manual antibiogram which is the standard of care to guide the empirical prescription of antibiotics
|
Participants will be assigned to manual antibiogram only.
|
|
Experimental: Mobile antibiogram
Participants will be assigned to the mobile antibiogram application to guide the empirical prescription of antibiotics in addition to standard of care.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pattern of antibiotic use
Time Frame: 12 months
|
Proportional change in antibiotic use among admitted patients
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pattern of antibiotic resistance
Time Frame: 12 months
|
Number of resistances to antibiotics among admitted patients
|
12 months
|
|
Acceptability of mobile antibiograms
Time Frame: 12 months
|
% of acceptability of mobile antibiograms among prescribers
|
12 months
|
|
Feasibility of mobile antibiograms
Time Frame: 12 months
|
% of feasibility mobile antibiogram among prescribers in tertiary referral hospitals in Tanzania
|
12 months
|
|
Adoption of mobile antibiogram
Time Frame: 12 months
|
% of adoption of mobile antibiogram among prescribers in tertiary referral hospitals in Tanzania
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Shinohara KI, Yasuda S, Kato G, Fujita M, Shigekawa H. Direct measurement of the chiral quaternary structure in a pi-conjugated polymer at room temperature. J Am Chem Soc. 2001 Apr 18;123(15):3619-20. doi: 10.1021/ja003023m. No abstract available.
- 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 Mar 22;12(1):4836. doi: 10.1038/s41598-022-08895-6.
- 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.
- 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: experience from prescribers and dispensers. JAC Antimicrob Resist. 2022 Nov 23;4(6):dlac118. doi: 10.1093/jacamr/dlac118. eCollection 2022 Dec.
- Costa-Paz M, Muscolo DL, Ayerza M, Makino A, Aponte-Tinao L. Magnetic resonance imaging follow-up study of bone bruises associated with anterior cruciate ligament ruptures. Arthroscopy. 2001 May;17(5):445-9. doi: 10.1053/jars.2001.23581.
- Guerrier C, Wartanian R, Boblet V, Rohmer E, Le Lirzin R. [Cervical pregnancy. Contribution of ultrasonography to diagnosis and therapeutic management]. Rev Fr Gynecol Obstet. 1995 Jul-Sep;90(7-9):352, 355-9. French.
- Fukunaga M, Tanaka C, Umeda M, Ebisu T, Aoki I, Watanabe Y, Higuchi T, Naruse S. Comparison of supplementary motor area activation between simple and complex motor task. Electroencephalogr Clin Neurophysiol Suppl. 1996;47:265-9. No abstract available.
- Dorward AJ, Stack BH. Diffuse malignant pleural mesothelioma in Glasgow. Br J Dis Chest. 1981 Oct;75(4):397-402. doi: 10.1016/0007-0971(81)90027-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2028
Study Registration Dates
First Submitted
January 21, 2026
First Submitted That Met QC Criteria
January 30, 2026
First Posted (Actual)
February 6, 2026
Study Record Updates
Last Update Posted (Actual)
February 6, 2026
Last Update Submitted That Met QC Criteria
January 30, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUHAS-REC-10-2025-3152
- 224127 (Other Grant/Funding Number: GSK Africa Open Lab)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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