Antimicrobial Prescribing PracticesAMR; AMU; DDDNCT07393308
Development and Implementation of Mobile Antibiograms to Optimize Empirical Antibiotic Prescriptions Among Prescribers in Tertiary Hospitals in Tanzania
A study testing Mobile antibiogram application in people with Antimicrobial Prescribing Practices and Antimicrobial Resistance (AMR), run by Muhimbili University of Health and Allied Sciences at 2 sites in Tanzania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Prescribing Practices, Antimicrobial Resistance (AMR)
- What is being tested?
- Mobile antibiogram application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesTanzania
- Study dates
- 1 Feb 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All prescribers working in the selected tertiary referral hospitals
- All prescribers owning smartphones
- Prescribers who consent to take part in the study
Who cannot join
- 1. Temporarily employed prescribers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wigilya Padili Mikomangwa, MSc contact
Tanzania2 sites
Benjamin Mkapa Hospital
Dodoma
Farida Khalifa Mbura, Microbiology and Immunology, faridambura1975@gmail.com
Mbeya Zonal Referral Hospital
Mbeya
Anthony A Nsojo, MD; MMED, ansojo43@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Mobile antibiogram application, standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile antibiogram applicationOther
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.
standard of careOther
Participants will be assigned to manual antibiogram only.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: standard of care |
| 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. Receives: Other: Mobile antibiogram application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of antibiotic use
Proportional change in antibiotic use among admitted patients
Measured: 12 months
Secondary outcomes (4)
Pattern of antibiotic resistance
Number of resistances to antibiotics among admitted patients
Measured: 12 months
Acceptability of mobile antibiograms
% of acceptability of mobile antibiograms among prescribers
Measured: 12 months
Feasibility of mobile antibiograms
% of feasibility mobile antibiogram among prescribers in tertiary referral hospitals in Tanzania
Measured: 12 months
Adoption of mobile antibiogram
% of adoption of mobile antibiogram among prescribers in tertiary referral hospitals in Tanzania
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial Prescribing PracticesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhimbili University of Health and Allied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393308
- Sponsor's protocol ID
- MUHAS-REC-10-2025-3152
- Other IDs
- 224127
- Acronym
- AMR; AMU; DDD
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39537568Nsojo 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.
PubMed 39403674Mutagonda 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.
PubMed 35318386Minzi 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.
PubMed 33727206Nkinda 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.
PubMed 36439992Zimbwe 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.
PubMed 39097319Sangeda 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.
PubMed 32974264Nkinda 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 Tanzania. BMC Health Serv Res. 2022 Jul 29;22(1):961. doi: 10.1186/s12913-022-08359-7.
PubMed 35902955Mikomangwa WP, Bwire GM, Kilonzi M, Mlyuka H, Mutagonda RF, Kibanga W, Marealle AI, Minzi O, Mwambete KD. The Existence of High Bacterial Resistance to Some Reserved Antibiotics in Tertiary Hospitals in Tanzania: A Call to Revisit Their Use. Infect Drug Resist. 2020 Jun 17;13:1831-1838. doi: 10.2147/IDR.S250158. eCollection 2020.
PubMed 32606832
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Optimization of Empirical Antibiotic Therapy: Development and Implementation of Mobile Antibiograms in Tertiary Hospitals in Tanzania
- ClinicalTrials.gov ID
- NCT07393308
- Acronym / sponsor ID
- AMR; AMU; DDD / MUHAS-REC-10-2025-3152
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Muhimbili University of Health and Allied SciencesUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | Active comparator | Other: standard of careParticipants will be subjected to manual antibiogram which is the standard of care to guide the empirical prescription of antibiotics |
| Mobile antibiogram | Experimental | Other: Mobile antibiogram applicationParticipants will be assigned to the mobile antibiogram application to guide the empirical prescription of antibiotics in addition to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All prescribers working in the selected tertiary referral hospitals
- All prescribers owning smartphones
- Prescribers who consent to take part in the study
Key exclusion criteria (1 listed)
- 1. Temporarily employed prescribers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile antibiogram applicationA 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 | Mobile antibiogram |
| standard of careParticipants will be assigned to manual antibiogram only. | Other | standard of care |
Primary outcome
Pattern of antibiotic use
Time frame: 12 months
Proportional change in antibiotic use among admitted patients
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 39537568Zimbwe 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.
- Results publication: PubMed 39403674Nsojo 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.
- Results publication: PubMed 35318386Mutagonda 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.
- Results publication: PubMed 33727206Minzi 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.
- Results publication: PubMed 36439992Nkinda 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.
- Results publication: PubMed 39097319Zimbwe 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.
- Results publication: PubMed 32974264Sangeda 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.
- Results publication: PubMed 35902955Nkinda 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 Tanzania. BMC Health Serv Res. 2022 Jul 29;22(1):961. doi: 10.1186/s12913-022-08359-7.
- Results publication: PubMed 32606832Mikomangwa WP, Bwire GM, Kilonzi M, Mlyuka H, Mutagonda RF, Kibanga W, Marealle AI, Minzi O, Mwambete KD. The Existence of High Bacterial Resistance to Some Reserved Antibiotics in Tertiary Hospitals in Tanzania: A Call to Revisit Their Use. Infect Drug Resist. 2020 Jun 17;13:1831-1838. doi: 10.2147/IDR.S250158. eCollection 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wigilya Padili Mikomangwa, MSc contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile antibiogram application in people with Antimicrobial Prescribing Practices and Antimicrobial Resistance (AMR), run by Muhimbili University of Health and Allied Sciences at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alphonce Ignace Marealle, PhD (+255713629365, marealle2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of antibiotic use (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07393308, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.