Antimicrobial ResistanceNCT05734391
Surveillance of Healthcare-associated Infections & Antimicrobial Resistance
An observational study of Antimicrobial Resistance, run by University of Pennsylvania at 2 sites in 2 countries.
Trial summary
The aims of this project, called "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE", are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs to use data to prevent, detect, and contain emerging AMR threats; 3) deploy… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antimicrobial Resistance
- How many people
- 642 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2022to 20 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: individuals being admitted to participating wards, of all clinical conditions, genders, and ages, meeting the inclusion/exclusion criteria
Who may be able to join
- hospital inpatient admission to participating wards.
Who cannot join
- diagnosis of a bleeding disorder
- platelet counts of <50,000
- diagnosis of coagulopathy
- presence of active bleeding
- inability to have a nares swab collected due to some other condition where nasal swabbing would be contraindicated
- inability to have a rectal swab collected due to some other condition where rectal swabbing would be contraindicated
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
The aims of this project, called "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE", are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs to use data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats
Read the detailed description
The World Health Organization (WHO) has declared antimicrobial resistance (AMR) one of the top 10 global public health threats facing humanity. AMR burden is higher in low-and-middle-income countries (LMICs) where, in recent decades, incidence and mortality from healthcare-associated infections (HAI) due to multidrug resistant organisms (MDRO) have dramatically increased. For example, neonatal sepsis is the third most common cause of neonatal deaths and multidrug-resistant Gram-negative bacteria are now the leading cause of sepsis among hospitalized neonates in south Asia and sub-Saharan Africa, including Botswana.1,2 One in three newborns with an MDRO bloodstream infection will die.3 In 2021, to respond to the global threat of AMR, U.S. Centers for Disease Control \& Prevention (CDC) announced the launch of a global "network of networks" to tackle the problem of AMR and healthcare-associated infections (HAIs). The network, called "Global Antimicrobial Resistance Laboratory and Response Network", solicited funding applications; in December of 2021, Botswana was announced as recipient of a 5-year cooperative agreement following the successful application for funding for a comprehensive AMR surveillance project. The project was developed by investigators from Botswana-UPenn Partnership (BUP) in collaboration with Botswana's Ministry of Health \& Wellness (MOHW) and the University of Botswana (UB).
- Conditions
- Antimicrobial Resistance
- Being tested
- Routine Infection control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Infection controlDiagnostic test
Also called Surveillance activity
routine part of hospital IPC activities
| Study group | Role | What they receive |
|---|---|---|
| inpatients | Individuals in inpatient wards Receives: Diagnostic Test: Routine Infection control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expertise
Ultimately, the goal of the SHARE project is to assemble the expertise and infrastructure needed to build a resilient HAI/AMR surveillance system fully-incorporated into MOHW's surveillance activities. The project aims to build capacity, both material and knowledge, in existing laboratory and IPC teams to face the dynamic challenges posed by HAIs and AMR
Measured: 12 months
Secondary outcomes (1)
Feasibility and Surveillance
SHARE's "Colonization Feasibility Study", will seek to assess the feasibility and surveillance potential of routine MDRO screening in hospitals, determining whether MDRO colonization can provide an "early warning system" for emerging AMR threats
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 posted21 Feb 2023
- Study start1 Oct 2022
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial ResistanceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebbing Lautenbach, University of Pennsylvania
- Investigators
- Ebbing Lautenbach, MD, MPH, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734391
- Sponsor's protocol ID
- 851492
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Healthcare-associated Infections & Antimicrobial Resistance
- ClinicalTrials.gov ID
- NCT05734391
- Acronym / sponsor ID
- 851492
- Conditions
- Antimicrobial Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 21 Feb 2023 (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.
The aims of this project, called "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE", are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs to use data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats
Detailed description
The World Health Organization (WHO) has declared antimicrobial resistance (AMR) one of the top 10 global public health threats facing humanity. AMR burden is higher in low-and-middle-income countries (LMICs) where, in recent decades, incidence and mortality from healthcare-associated infections (HAI) due to multidrug resistant organisms (MDRO) have dramatically increased. For example, neonatal sepsis is the third most common cause of neonatal deaths and multidrug-resistant Gram-negative bacteria are now the leading cause of sepsis among hospitalized neonates in south Asia and sub-Saharan Africa, including Botswana.1,2 One in three newborns with an MDRO bloodstream infection will die.3 In 2021, to respond to the global threat of AMR, U.S. Centers for Disease Control \& Prevention (CDC) announced the launch of a global "network of networks" to tackle the problem of AMR and healthcare-associated infections (HAIs). The network, called "Global Antimicrobial Resistance Laboratory and Response Network", solicited funding applications; in December of 2021, Botswana was announced as recipient of a 5-year cooperative agreement following the successful application for funding for a comprehensive AMR surveillance project. The project was developed by investigators from Botswana-UPenn Partnership (BUP) in collaboration with Botswana's Ministry of Health \& Wellness (MOHW) and the University of Botswana (UB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inpatients | – | Diagnostic Test: Routine Infection controlIndividuals in inpatient wards |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- individuals being admitted to participating wards, of all clinical conditions, genders, and ages, meeting the inclusion/exclusion criteria
Key inclusion criteria (1 listed)
- hospital inpatient admission to participating wards.
Key exclusion criteria (6 listed)
- diagnosis of a bleeding disorder
- platelet counts of <50,000
- diagnosis of coagulopathy
- presence of active bleeding
- inability to have a nares swab collected due to some other condition where nasal swabbing would be contraindicated
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 |
|---|---|---|
| Routine Infection controlAlso: Surveillance activityroutine part of hospital IPC activities | Diagnostic test | inpatients |
Primary outcome
Expertise
Time frame: 12 months
Ultimately, the goal of the SHARE project is to assemble the expertise and infrastructure needed to build a resilient HAI/AMR surveillance system fully-incorporated into MOHW's surveillance activities. The project aims to build capacity, both material and knowledge, in existing laboratory and IPC teams to face the dynamic challenges posed by HAIs and AMR
1 secondary outcome
Feasibility and Surveillance
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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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. This study is not recruiting at the moment.
Ebbing Lautenbach, MD, MPH, MSCE principal investigator
University of Pennsylvania
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antimicrobial Resistance, run by University of Pennsylvania at 2 sites in 2 countries.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 23 Oct 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 United States, Botswana. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expertise (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.