Hospital-acquired InfectionsHAMRNCT03411538
Mortality Related to AMR in Patients With Hospital-acquired Infection
An observational study of Hospital-acquired Infections, run by University of Oxford at 1 site in Thailand.
Trial summary
This is a prospective surveillance study to estimate excess deaths due to and risk factors associated with antibiotic-resistant infection among patients with hospital-acquired infection (HAI) in a resource-limited setting. We will focus on six pathogenic bacteria that are of clinically important in the hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospital-acquired Infections
- What is being tested?
- Collect data on clinical history
- How many people
- 2,069 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2018to 28 Feb 2020
- 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: The target study subjects include male and female patients of any age admit at the hospital, and acquired hospital-acquired bacterial infection during hospital stay. We will focus on six key pathogens that were in the WHO global priority list of antibiotic-resistant bacteria and are also of clinical importance in resource-limited settings, namely: * Staphylococcus aureus * Enterococcus spp * Escherichia coli * Klebsiella pneumoniae * Pseudomonas aeruginosa * Acinetobacter spp The severity of underlying illness will be assessed using Charlson Comorbidity Index (CCI) score and severity of the infection will be assessed using Sequential Organ Failure Assessment (SOFA) score. These score will be reported to the physician whenever appropriate.
Who may be able to join
- Male or female of any age admit at Sunpasitthiprasong Hospital
- At least one of the six organisms, which include Staphylococcus aureus, Enterococcus spp., Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter spp., isolated from clinical specimen >48 hours after admission
- Acquired Bloodstream infection (BSI), Lower-respiratory tract infection(LRTI), Skin/Soft tissue infection (SSTI), Surgical-site infection (SSI), Urinary tract infection (UTI) or infection at other body sites >48 hours after admit at the hospital
Who cannot join
- Clinical symptoms of current infection presented ≤48 hours of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Surveillance Study for Outcome and Risk Factors Associated With Antibiotic-resistant Infections Among Patients With Hospital-acquired Infections
This is a prospective surveillance study to estimate excess deaths due to and risk factors associated with antibiotic-resistant infection among patients with hospital-acquired infection (HAI) in a resource-limited setting. We will focus on six pathogenic bacteria that are of clinically important in the hospital.
Read the detailed description
We will first identify patients with pathogenic bacteria isolated from clinical sample collected >48 hours after admission. These patients will then be screened for eligibility criteria. Signed informed consent will be sought from the enrolled patients. The primary outcome is survival status within 28 days since the first specimen culture positive for one of the six organisms of interest. All patients with hospital-acquired infection will be assessed for in-hospital 28-day survival as part of the routine hospital surveillance system. Follow-up to confirm 28-day outcome via telephone call will be performed only if patient signed informed consent and permission is granted. All isolates from positive cultures will be collected and stored securely.
This study will not interfere with standard patient care or routine diagnosis procedure, hence subject will receive no direct medical harm or benefits from being in the study. Researchers of this study will not be involved in the management, care and treatment of study subjects. Patient care will remain under the responsibility of the attending medical staff according to standard practice of care. The study team will work closely with the hospital Infectious Control team to screen and enroll patients as part of the HAI surveillance data system in Sunpasitthiprasong Hospital. This study will be an enhancement of the current HAI surveillance system, which will provide data on 28-day survival status, Charlson Comorbidities Index (CCI) score and Sequential Organ Failure Assessment (SOFA) score for each patient and risk factors related to acquiring hospital-acquired infection to the hospital Infectious Control (IC) team.
- Conditions
- Hospital-acquired Infections
- Being tested
- Collect data on clinical history
- Keywords
- antibiotic-resistant infections, risk factors, prospective surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect data on clinical historyOther
Collect data on clinical history, clinical manifestation, comorbidity, admission data, use of invasive medical intervention, history of antibiotic treatment and antibiotic susceptibility test results
| Study group | Role | What they receive |
|---|---|---|
| Hospital-acquired bacterial infection | Not described Receives: Other: Collect data on clinical history |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Mar 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital-acquired InfectionsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- 2,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Sanpasitthiprasong Hospital, Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
- Investigators
- Assoc. Prof. Direk Limmathurotsakul, MD, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411538
- Sponsor's protocol ID
- MICRO1707
- Acronym
- HAMR
- Status last verified
- Jul 2018
- First submitted
- 19 Jan 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lim C, Teparrukkul P, Nuntalohit S, Boonsong S, Nilsakul J, Srisamang P, Sartorius B, White NJ, Day NPJ, Cooper BS, Limmathurotsakul D. Excess Mortality Attributable to Hospital-Acquired Antimicrobial-Resistant Infections: A 2-Year Prospective Surveillance Study in Northeast Thailand. Open Forum Infect Dis. 2022 Jun 20;9(9):ofac305. doi: 10.1093/ofid/ofac305. eCollection 2022 Sep.
PubMed 36092827
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Surveillance Study for Outcome and Risk Factors Associated With Antibiotic-resistant Infections Among Patients With Hospital-acquired Infections
- ClinicalTrials.gov ID
- NCT03411538
- Acronym / sponsor ID
- HAMR / MICRO1707
- Conditions
- Hospital-acquired Infections
- Keywords
- antibiotic-resistant infections, risk factors, prospective surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,069 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Sanpasitthiprasong Hospital, Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 26 Jan 2018 (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.
This is a prospective surveillance study to estimate excess deaths due to and risk factors associated with antibiotic-resistant infection among patients with hospital-acquired infection (HAI) in a resource-limited setting. We will focus on six pathogenic bacteria that are of clinically important in the hospital.
Detailed description
We will first identify patients with pathogenic bacteria isolated from clinical sample collected >48 hours after admission. These patients will then be screened for eligibility criteria. Signed informed consent will be sought from the enrolled patients. The primary outcome is survival status within 28 days since the first specimen culture positive for one of the six organisms of interest. All patients with hospital-acquired infection will be assessed for in-hospital 28-day survival as part of the routine hospital surveillance system. Follow-up to confirm 28-day outcome via telephone call will be performed only if patient signed informed consent and permission is granted. All isolates from positive cultures will be collected and stored securely.
This study will not interfere with standard patient care or routine diagnosis procedure, hence subject will receive no direct medical harm or benefits from being in the study. Researchers of this study will not be involved in the management, care and treatment of study subjects. Patient care will remain under the responsibility of the attending medical staff according to standard practice of care. The study team will work closely with the hospital Infectious Control team to screen and enroll patients as part of the HAI surveillance data system in Sunpasitthiprasong Hospital. This study will be an enhancement of the current HAI surveillance system, which will provide data on 28-day survival status, Charlson Comorbidities Index (CCI) score and Sequential Organ Failure Assessment (SOFA) score for each patient and risk factors related to acquiring hospital-acquired infection to the hospital Infectious Control (IC) team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital-acquired bacterial infection | – | Other: Collect data on clinical history |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target study subjects include male and female patients of any age admit at the hospital, and acquired hospital-acquired bacterial infection during hospital stay. We will focus on six key pathogens that were in the WHO global priority list of antibiotic-resistant bacteria and are also of clinical importance in resource-limited settings, namely: * Staphylococcus aureus * Enterococcus spp * Escherichia coli * Klebsiella pneumoniae * Pseudomonas aeruginosa * Acinetobacter spp The severity of underlying illness will be assessed using Charlson Comorbidity Index (CCI) score and severity of the infection will be assessed using Sequential Organ Failure Assessment (SOFA) score. These score will be reported to the physician whenever appropriate.
Key inclusion criteria (3 listed)
- Male or female of any age admit at Sunpasitthiprasong Hospital
- At least one of the six organisms, which include Staphylococcus aureus, Enterococcus spp., Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter spp., isolated from clinical specimen >48 hours after admission
- Acquired Bloodstream infection (BSI), Lower-respiratory tract infection(LRTI), Skin/Soft tissue infection (SSTI), Surgical-site infection (SSI), Urinary tract infection (UTI) or infection at other body sites >48 hours after admit at the hospital
Key exclusion criteria (1 listed)
- Clinical symptoms of current infection presented ≤48 hours of admission
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 |
|---|---|---|
| Collect data on clinical historyCollect data on clinical history, clinical manifestation, comorbidity, admission data, use of invasive medical intervention, history of antibiotic treatment and antibiotic susceptibility test results | Other | Hospital-acquired bacterial infection |
Primary outcome
28-day mortality
Time frame: 28 days
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 16 Sep 2020.
- Derived from this study: PubMed 36092827Lim C, Teparrukkul P, Nuntalohit S, Boonsong S, Nilsakul J, Srisamang P, Sartorius B, White NJ, Day NPJ, Cooper BS, Limmathurotsakul D. Excess Mortality Attributable to Hospital-Acquired Antimicrobial-Resistant Infections: A 2-Year Prospective Surveillance Study in Northeast Thailand. Open Forum Infect Dis. 2022 Jun 20;9(9):ofac305. doi: 10.1093/ofid/ofac305. eCollection 2022 Sep.
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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.
Assoc. Prof. Direk Limmathurotsakul, MD principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital-acquired Infections, run by University of Oxford at 1 site in Thailand.
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: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
28-day mortality (time frame: 28 days). 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 NCT03411538, which also lists 1 linked publication.
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 16 Sep 2020.