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Mortality Related to AMR in Patients With Hospital-acquired Infection (HAMR)

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ClinicalTrials.gov Identifier: NCT03411538
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Sanpasitthiprasong Hospital
Mahidol Oxford Tropical Medicine Research Unit
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment
Hospital-acquired Infections Other: Collect data on clinical history

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.


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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Surveillance Study for Outcome and Risk Factors Associated With Antibiotic-resistant Infections Among Patients With Hospital-acquired Infections
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hospital-acquired bacterial infection Other: 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




Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411538


Contacts
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Contact: Cherry Lim +66-2-203-6304 cherry@tropmedres.ac
Contact: Assoc. Prof. Direk Limmathurotsakul, MD +66-2-203-6304 direk@tropmedres.ac

Locations
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Thailand
Sunpasitthiprasong Hospital Recruiting
Ubon Ratchathani, Thailand, 34000
Contact: Prapit Teparrakkul, MD    0818779864    prapith1@hotmail.com   
Sponsors and Collaborators
University of Oxford
Sanpasitthiprasong Hospital
Mahidol Oxford Tropical Medicine Research Unit
Investigators
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Principal Investigator: Assoc. Prof. Direk Limmathurotsakul, MD Mahidol Oxford Tropical Medicine Research Unit

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03411538     History of Changes
Other Study ID Numbers: MICRO1707
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oxford:
antibiotic-resistant infections
risk factors
prospective surveillance

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents