NCT07393308

Brief 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. This study aims to determine the effectiveness of mobile antibiograms in optimizing empirical antibiotic therapy in tertiary hospitals in Tanzania.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Jun 2028

First Submitted

Initial submission to the registry

January 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 21, 2026

Last Update Submit

January 30, 2026

Conditions

Antimicrobial Resistance (AMR)Antimicrobial Prescribing Practices

Outcome Measures

Primary Outcomes (1)

  • Pattern of antibiotic use

    Proportional change in antibiotic use among admitted patients

    12 months

Secondary Outcomes (4)

  • Pattern of antibiotic resistance

    12 months

  • Acceptability of mobile antibiograms

    12 months

  • Feasibility of mobile antibiograms

    12 months

  • Adoption of mobile antibiogram

    12 months

Study Arms (2)

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

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.

Other: Mobile antibiogram application

Interventions

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.

Mobile antibiogram
standard of careOTHER

Participants will be assigned to manual antibiogram only.

standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. Temporarily employed prescribers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Benjamin Mkapa Hospital

Dodoma, Tanzania

Location

Mbeya Zonal Referral Hospital

Mbeya, Tanzania

Location

Related Publications (9)

  • 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: 39537568RESULT

  • 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: 39403674RESULT

  • 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.

    PMID: 35318386RESULT

  • 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: 33727206RESULT

  • 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.

    PMID: 36439992RESULT

  • 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: 39097319RESULT

  • 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: 32974264RESULT

  • 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 Tanzania. BMC Health Serv Res. 2022 Jul 29;22(1):961. doi: 10.1186/s12913-022-08359-7.

    PMID: 35902955RESULT

  • Mikomangwa 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.

    PMID: 32606832RESULT

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Alphonce Ignace Marealle, PhD

CONTACT

+255713629365marealle2010@gmail.com

Wigilya Padili Mikomangwa, MSc

CONTACT

wpad.miko@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 6, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TA(2)