Infectious DiseaseNCT07069400
An International Observational Study of Adults With Acute Infection
An observational study of Infectious Disease, run by University of Minnesota at 56 sites in 21 countries.
Trial summary
Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease
- How many people
- 1,500 participants
- Where
- 56 sitesin 21 countries
- Study dates
- 25 Aug 2025to 8 Jun 2027
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be enrolled at study sites globally. Study personnel at the enrolling site will confirm eligibility and obtain consent prior to beginning study procedures. Signing of the informed consent document signifies study entry and Study Day 0. The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection. All participants will meet the eligibility criteria below. Specific studies executed with this master protocol may narrow the eligibility criteria to a more specific population (that is, a subset of patients who meet the eligibility criteria in this overarching protocol).
Who may be able to join
- Age ≥18 years old
- Admitted to hospital (or in an emergency department with anticipated hospital admission) for the management of a suspected or confirmed acute infectious disease.
- Onset of symptoms of an infectious disease within the past 30 days.
- Informed consent for study participation by the participant or a surrogate decision maker if the participant lacks capacity for consent.
Who cannot join
- Current imprisonment (this does not include quarantine for an infectious disease).
- Patient undergoing comfort care measures only such that treatment focuses on end- of-life symptom management over prolongation of life.
- Expected inability or unwillingness to participate in study procedures.
- In the opinion of the investigator, participation in the study is not in the best interest of the patient.
Trial locations and contacts
56 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
56 sites in 21 countries
United States20 sites, 20 recruiting
- Recruiting
University of Illinois at Chicago (Site 008-012)
Chicago, Illinois, 60612
Hennepin ICC, icsarihenn@strive-network.org
- Recruiting
Cleveland Clinic Foundation (Site 207-001)
Cleveland, Ohio, 44195
Nashville ICC, icsarinash@strive-network.org
- Recruiting
UT Southwestern Medical Center (084-001)
Dallas, Texas, 75390
Washington ICC, icsariwdc@strive-network.org
- Recruiting
Duke University (301-006)
Durham, North Carolina, 27710
New York ICC, icsariny@strive-network.org
- Recruiting
Lutheran Medical Group
Fort Wayne, Indiana, 46804
New York ICC, icsariny@strive-network.org
- Recruiting
MEDVAMC (Site 074-006)
Houston, Texas, 77030-4211
Washington ICC, icsariwdc@strive-network.org
- Recruiting
University of Kansas Medical Center (Site 080-044)
Kansas City, Kansas, 66160
Hennepin ICC, icsarihenn@strive-network.org
- Not yet recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Cavan Reilly, PhD, Reill017@umn.edu
- Recruiting
West Virginia University Medicine (301-023)
Morgantown, West Virginia, 26506
New York ICC, icsariny@strive-network.org
- Recruiting
Intermountain Medical Center (Site 211-001)
Murray, Utah, 84107
Nashville ICC, icsarinash@strive-network.org
- Recruiting
Vanderbilt University Medical Center (Site 212-001)
Nashville, Tennessee, 37232
Nashville ICC, icsarinash@strive-network.org
- Recruiting
New York University Langone Health (301-013)
New York, New York, 10016
New York ICC, icsariny@strive-network.org
- Recruiting
Mount Sinai Medical Center (Site 301-012)
New York, New York, 11234
New York ICC, icsariny@strive-network.org
- Recruiting
University of Nebraska Medical Center (Site 080-045)
Omaha, Nebraska, 68198-5400
Hennepin ICC, icsarihenn@strive-network.org
- Recruiting
Orlando VA Medical Center (074-032)
Orlando, Florida, 32827
Washington ICC, icsariwdc@strive-network.org
- Recruiting
Stanford University Hospital & Clinics (Site 203-003)
Palo Alto, California, 94305
Nashville ICC, icsarinash@strive-network.org
- Recruiting
Mayo Clinic (Site 054-001)
Rochester, Minnesota, 55905
Hennepin ICC, icsarihenn@strive-network.org
- Recruiting
UCSF Medical Center (Site 203-001)
San Francisco, California, 94143
Nashville ICC, icsarinash@strive-network.org
- Recruiting
Banner University Medical Center Tucson
Tucson, Arizona, 85719
Nashville ICC, icsarinash@strive-network.org
- Recruiting
Wake Forest Baptist Health (210-001)
Winston-Salem, North Carolina, 27157
Nashville ICC, icsarinash@strive-network.org
Australia10 sites, 10 recruiting
- Recruiting
Royal Brisbane and Women's Hospital (Site 612-055)
Brisbane, Queensland, 4029
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Royal Prince Alfred Hospital (612-056)
Camperdown, New South Wales, 2050
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Monash Health (612-009)
Clayton, Victoria, 3168
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Austin Health (Site 612-020)
Heidelberg, Victoria, 3084
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Liverpool Hospital
Liverpool
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
The Alfred Hospital (Site 612-017)
Melbourne, Victoria, 3004
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Fiona Stanley Hospital
Murdoch, 6150
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
The Royal Melbourne Hospital (612-025)
Parkville, Victoria, 3050
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
St. Vincent's Hospital (612-002)
Sydney, New South Wales, 2010
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Westmead Hospital (Site 612-058)
Westmead, New South Wales, 2145
Sydney ICC, icsarisyd@strive-network.org
Argentina2 sites, 2 recruiting
- Recruiting
Hospital General de Agudos JM Ramos Mejia (Site 611-001)
Buenos Aires, C1221ADC
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Instituto Medico Platense (611-025)
La Plata, Buenos Aires, B1900AVG
Sydney ICC, icsarisyd@strive-network.org
France2 sites, 2 recruiting
- Recruiting
Hospices Civiles de Lyon (631-033)
Lyon, 69002
ANRS ICC, icsarianrs@strive-network.org
- Recruiting
Hospital St Louis (631-019)
Paris, 75010
ANRS ICC, icsarianrs@strive-network.org
Greece2 sites, 2 recruiting
- Recruiting
Evangelismos General Hospital (Site 635-020)
Athens, Attica, 10676
London ICC, icsarilon@strive-network.org
- Recruiting
3rd Dept of Medicine, Medical School (Site 635-022)
Athens, Attica, 11527
London ICC, icsarilon@strive-network.org
Japan2 sites, 2 recruiting
- Recruiting
Japan Institute for Health Security
Tokyo, 162-8655
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
Sydney ICC, icsarisyd@strive-network.org
Peru2 sites, 2 recruiting
- Recruiting
Hospital Nacional Guillermo Almenara Irigoyen (Site 651-003)
Lima, 15033
Sydney ICC, icsariwdc@strive-network.org
- Recruiting
Instituto Nacional de Entermadades Neoplasicas (Site 651-012
Lima, 15038
Washington ICC, icsariwdc@strive-network.org
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Sydney ICC, icsarisyd@strive-network.org
- Recruiting
Seoul St. Mary's Hospital
Seoul, 06591
Sydney ICC, icsarisyd@strive-network.org
Uganda2 sites, 2 recruiting
- Recruiting
MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601)
Entebbe
London ICC, icsarilon@strive-network.org
- Recruiting
Lira Regional Referral Hospital (Site 634-605)
Lira
London ICC, icsarilon@strive-network.org
Brazil1 site, 1 recruiting
- Recruiting
Associaco Beneficente Siria - HCor (649-203)
São Paulo, São Paulo, 04004-030
Washington ICC, icsariwdc@strive-network.org
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
CERMIPA (Site 403-001)
Abidjan
ANRS ICC, icsarianrs@strive-network.org
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet, CHIP (625-006)
Copenhagen, 2100
Copenhagen ICC, icsaricph@strive-network.org
Germany1 site, 1 recruiting
- Recruiting
Klinik I fur Innere Medizin der Universitat zu Koln (622-008)
Cologne, 50937
Copenhagen ICC, icsaricph@strive-network.org
Guinea1 site, 1 recruiting
- Recruiting
SMIT du CHU de Donka
Conakry
ANRS ICC, icsarianrs@strive-network.org
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (653-001)
Mexico City, Mexico City, 14080
Hennepin ICC, icsarihenn@strive-network.org
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, 308443
Sydney ICC, icsarisyd@strive-network.org
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol (Site 626-003)
Badalona, Barcelona, 08916
Copenhagen ICC, icsaricph@strive-network.org
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn University and The HIV-NAT (Site 613-001)
Bangkok, 10330
Sydney ICC, icsarisyd@strive-network.org
Ukraine1 site, 1 recruiting
- Recruiting
Central City Clinical Hospital of Ivano-Frankivsk City Council (627-302)
Ivano-Frankivsk, 76018
Copenhagen ICC, icsaricph@strive-network.org
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital (Site 634-006)
London, NW3 2QG
London ICC, icsarilon@strive-network.org
Zimbabwe1 site, 1 recruiting
- Recruiting
Parirenyatwa General Hospital
Harare
London ICC, icsarilon@strive-network.org
About this study
Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.
- Conditions
- Infectious Disease
- Being tested
- No intervention
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Study group | The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 28 Mortality
All-cause mortality
Measured: Day 28
Days to recovery scale (DRS)
The Days to Recovery Scale (DRS) is an ordinal ranked outcome that includes the concepts of mortality and time to recovery, with recovery defined as being discharged from the hospital and reaching home for the duration of the follow- up. At the end of the follow-up period, each patient is classified into one of the DRS categories based on vital status, hospitalization status, and duration it took to reach recovery.
Measured: Day 28
Time to Sustained Recovery
Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 days.
Measured: Day 28
Ordinal outcome for clinical improvement - Day 7
For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.
Measured: Day 7
Organ support free days
the number of days between enrollment and hospital discharge or day 28 that the participant did not receive support for some organ (lungs, kidneys, etc.)
Measured: Day 28
The Sequential Organ Failure Assessment (SOFA) score - Day 28
The SOFA score is one of the most widely used scoring systems in critically ill patients and has also been validated in hospitalized patients with suspected infection outside the ICU. This score assesses organ dysfunction across 6 organ systems. To facilitate use of the SOFA score across a broad range of sites, including those in low- and-middle income countries (LMICs), SpO2 may be substituted for PaO2, and the presence of scleral icterus or jaundice may be substituted for serum bilirubin level . Only clinically available data will be used to calculate SOFA scores. Laboratory tests will not be completed by the study to calculate SOFA scores.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start25 Aug 2025
- Primary completion8 Jun 2027 (estimated)
- Study completion8 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cavan Reilly, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069400
- Sponsor's protocol ID
- STRIVE 002
- Status last verified
- Aug 2026
- First submitted
- 12 May 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Observational Study of Adults With Acute Infection
- ClinicalTrials.gov ID
- NCT07069400
- Acronym / sponsor ID
- STRIVE 002
- Conditions
- Infectious Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 8 Jun 2027 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 16 Jul 2025 (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.
Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: No interventionThe study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled at study sites globally. Study personnel at the enrolling site will confirm eligibility and obtain consent prior to beginning study procedures. Signing of the informed consent document signifies study entry and Study Day 0. The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection. All participants will meet the eligibility criteria below. Specific studies executed with this master protocol may narrow the eligibility criteria to a more specific population (that is, a subset of patients who meet the eligibility criteria in this overarching protocol).
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Admitted to hospital (or in an emergency department with anticipated hospital admission) for the management of a suspected or confirmed acute infectious disease.
- Onset of symptoms of an infectious disease within the past 30 days.
- Informed consent for study participation by the participant or a surrogate decision maker if the participant lacks capacity for consent.
Key exclusion criteria (4 listed)
- Current imprisonment (this does not include quarantine for an infectious disease).
- Patient undergoing comfort care measures only such that treatment focuses on end- of-life symptom management over prolongation of life.
- Expected inability or unwillingness to participate in study procedures.
- In the opinion of the investigator, participation in the study is not in the best interest of the patient.
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 |
|---|---|---|
| No interventionThis is an observational study | Other | Study group |
Primary outcome
Day 28 Mortality
Time frame: Day 28
All-cause mortality
Days to recovery scale (DRS)
Time frame: Day 28
The Days to Recovery Scale (DRS) is an ordinal ranked outcome that includes the concepts of mortality and time to recovery, with recovery defined as being discharged from the hospital and reaching home for the duration of the follow- up. At the end of the follow-up period, each patient is classified into one of the DRS categories based on vital status, hospitalization status, and duration it took to reach recovery.
Time to Sustained Recovery
Time frame: Day 28
Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 days.
Ordinal outcome for clinical improvement - Day 7
Time frame: Day 7
For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.
Organ support free days
Time frame: Day 28
the number of days between enrollment and hospital discharge or day 28 that the participant did not receive support for some organ (lungs, kidneys, etc.)
The Sequential Organ Failure Assessment (SOFA) score - Day 28
Time frame: Day 28
The SOFA score is one of the most widely used scoring systems in critically ill patients and has also been validated in hospitalized patients with suspected infection outside the ICU. This score assesses organ dysfunction across 6 organ systems. To facilitate use of the SOFA score across a broad range of sites, including those in low- and-middle income countries (LMICs), SpO2 may be substituted for PaO2, and the presence of scleral icterus or jaundice may be substituted for serum bilirubin level . Only clinically available data will be used to calculate SOFA scores. Laboratory tests will not be completed by the study to calculate SOFA scores.
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 27 Aug 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.
Cavan Reilly, PhD principal investigator
University of Minnesota
56 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease, run by University of Minnesota at 56 sites in 21 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Australia, Argentina, France, Greece and 16 more countries. 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 Rebecca Schoenecker (612-624-9644, webe0376@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 28 Mortality (time frame: Day 28). The study lists 6 primary outcomes in all. 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 27 Aug 2026.