Mortality Related to AMR in Patients With Hospital-acquired Infection

NCT ID: NCT03411538

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2069 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-02-28

Brief Summary

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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

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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

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Hospital-acquired Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospital-acquired bacterial infection

Collect data on clinical history

Intervention Type OTHER

Collect data on clinical history, clinical manifestation, comorbidity, admission data, use of invasive medical intervention, history of antibiotic treatment and antibiotic susceptibility test results

Interventions

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Collect data on clinical history

Collect data on clinical history, clinical manifestation, comorbidity, admission data, use of invasive medical intervention, history of antibiotic treatment and antibiotic susceptibility test results

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

• Clinical symptoms of current infection presented ≤48 hours of admission
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanpasitthiprasong Hospital

OTHER_GOV

Sponsor Role collaborator

Mahidol Oxford Tropical Medicine Research Unit

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Assoc. Prof. Direk Limmathurotsakul, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

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Sunpasitthiprasong Hospital

Ubon Ratchathani, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 36092827 (View on PubMed)

Other Identifiers

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MICRO1707

Identifier Type: -

Identifier Source: org_study_id

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