Multi Drug Resistant BacteriaNCT05983861
Risk Factors for Multidrug Resistant Bacteria at ICU Admission
An observational study of Multi Drug Resistant Bacteria, run by José Raimundo Araujo de Azevedo.
Trial summary
The objective of this single-center prospective observational study is to evaluate possible independent risk factors for multidrug-resistant (MDR) bacteria upon ICU admission by analyzing comorbidities, epidemiological data, and laboratory/microbiological information of the subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi Drug Resistant Bacteria
- What is being tested?
- Identification o Multi Drug Resistant Bacteria
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and with a positive microbiologic result.
Who may be able to join
- All patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and a microbiological positive result for bacteria
Who cannot join
- Patients with results considered as contamination according to the institutional protocol.
- Surgical wound and bloodstream infections.
- Microbiological isolation of only fungi.
- Vigilance cultures, such as anal, rectal, nasal, and axillary swabs.
Trial locations and contacts
No sites are listed yet.
About this study
The objective of this single-center prospective observational study is to evaluate possible independent risk factors for multidrug-resistant (MDR) bacteria upon ICU admission by analyzing comorbidities, epidemiological data, and laboratory/microbiological information of the subjects.
Read the detailed description
Background: Infection is one of the main reason for a patient to be admitted to an intensive care unit (ICU) and it's fundamental to use the right antibiotic as soon as possible, possibly needing broad-spectrum antibiotics. However, the main problem is that widening the spectrum of drugs will generate pressure on the hospital microbiota, leading to the development of multi-drug resistant bacteria
Purpose: A large number of ICU-admitted patients have infection/sepsis as their major problem, requiring treatment with antibiotics. With knowledge of the presumed risk factors for antibiotic resistance, the assistant physician could use broad-spectrum drugs with greater certainty.
Objectives: Our objective will be to evaluate risk factors for infection caused by multi-drug resistant germs upon ICU admission and assess the severity of the disease in comparison to patients infected with susceptible bacteria. Ultimately, we aim to develop and validate a clinical tool to assist physicians in selecting the appropriate antibiotic for their patients
Methods: An observational prospective study with a control group will be conducted, including all patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and with a positive microbiologic result. Patients with isolation of only susceptible bacteria will be allocated to the control group, while patients with MDR bacteria will be assigned to the study group, referred to as the MDR group. The data to be collected will include sex, age, previous use of antibiotics in the last three months, previous hospital admissions, previous isolation of MDR germs, sensitivity profile of the isolated germs, severity of disease (measured by SAPS 3), presence of sepsis diagnosis at admission, length of stay in the ICU, and 28-day mortality
- Conditions
- Multi Drug Resistant Bacteria
- Being tested
- Identification o Multi Drug Resistant Bacteria
- Keywords
- Infection, Multi drug Resistant bacteria, Risk Factors, Critical Care, Score
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification o Multi Drug Resistant BacteriaDiagnostic test
Identification o Multi Drug Resistant Bacteria
| Study group | Role | What they receive |
|---|---|---|
| Multi drug resistant group | All critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug resistant bacteria isolation : Receives: Diagnostic Test: Identification o Multi Drug Resistant Bacteria | |
| Multi sensible bacteria group | All critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug sensible bacteria isolation : Receives: Diagnostic Test: Identification o Multi Drug Resistant Bacteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine risk factors for multi-drug resistant germs in ICU admission.
Analysis of resistance profile of germs and patient's comorbidities to determine the risk factors for drug resistance.
Measured: 28 days
Secondary outcomes (3)
Mortality between control and case group
Compare mortality in 28 days between patients with infection caused by MDR bacteria and non-resistant bacteria.
Measured: 28 days
Mean LOS of each group
Compare the length of stay in ICU between the control and case groups.
Measured: 28 days
Severity between groups using SAPS 3
Compare the severity of disease between groups using the SAPS 3 score.
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 posted9 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multi Drug Resistant BacteriaStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- José Raimundo Araujo de Azevedo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983861
- Sponsor's protocol ID
- 17/2023
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niederman MS, Baron RM, Bouadma L, Calandra T, Daneman N, DeWaele J, Kollef MH, Lipman J, Nair GB. Initial antimicrobial management of sepsis. Crit Care. 2021 Aug 26;25(1):307. doi: 10.1186/s13054-021-03736-w.
PubMed 34446092Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
PubMed 34605781Bassetti M, Rello J, Blasi F, Goossens H, Sotgiu G, Tavoschi L, Zasowski EJ, Arber MR, McCool R, Patterson JV, Longshaw CM, Lopes S, Manissero D, Nguyen ST, Tone K, Aliberti S. Systematic review of the impact of appropriate versus inappropriate initial antibiotic therapy on outcomes of patients with severe bacterial infections. Int J Antimicrob Agents. 2020 Dec;56(6):106184. doi: 10.1016/j.ijantimicag.2020.106184. Epub 2020 Oct 9.
PubMed 33045353Kalil AC, Johnson DW, Lisco SJ, Sun J. Early Goal-Directed Therapy for Sepsis: A Novel Solution for Discordant Survival Outcomes in Clinical Trials. Crit Care Med. 2017 Apr;45(4):607-614. doi: 10.1097/CCM.0000000000002235.
PubMed 28067711Liu VX, Fielding-Singh V, Greene JD, Baker JM, Iwashyna TJ, Bhattacharya J, Escobar GJ. The Timing of Early Antibiotics and Hospital Mortality in Sepsis. Am J Respir Crit Care Med. 2017 Oct 1;196(7):856-863. doi: 10.1164/rccm.201609-1848OC.
PubMed 28345952Wong D, Wong T, Romney M, Leung V. Comparative effectiveness of beta-lactam versus vancomycin empiric therapy in patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. Ann Clin Microbiol Antimicrob. 2016 Apr 26;15:27. doi: 10.1186/s12941-016-0143-3.
PubMed 27112143Fernandez-Martinez NF, Carcel-Fernandez S, De la Fuente-Martos C, Ruiz-Montero R, Guzman-Herrador BR, Leon-Lopez R, Gomez FJ, Guzman-Puche J, Martinez-Martinez L, Salcedo-Leal I. Risk Factors for Multidrug-Resistant Gram-Negative Bacteria Carriage upon Admission to the Intensive Care Unit. Int J Environ Res Public Health. 2022 Jan 18;19(3):1039. doi: 10.3390/ijerph19031039.
PubMed 35162062
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Multidrug Resistant Bacteria at ICU Admission
- ClinicalTrials.gov ID
- NCT05983861
- Acronym / sponsor ID
- 17/2023
- Conditions
- Multi Drug Resistant Bacteria
- Keywords
- Infection, Multi drug Resistant bacteria, Risk Factors, Critical Care, Score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- José Raimundo Araujo de AzevedoUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 9 Aug 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 objective of this single-center prospective observational study is to evaluate possible independent risk factors for multidrug-resistant (MDR) bacteria upon ICU admission by analyzing comorbidities, epidemiological data, and laboratory/microbiological information of the subjects.
Detailed description
Background: Infection is one of the main reason for a patient to be admitted to an intensive care unit (ICU) and it's fundamental to use the right antibiotic as soon as possible, possibly needing broad-spectrum antibiotics. However, the main problem is that widening the spectrum of drugs will generate pressure on the hospital microbiota, leading to the development of multi-drug resistant bacteria
Purpose: A large number of ICU-admitted patients have infection/sepsis as their major problem, requiring treatment with antibiotics. With knowledge of the presumed risk factors for antibiotic resistance, the assistant physician could use broad-spectrum drugs with greater certainty.
Objectives: Our objective will be to evaluate risk factors for infection caused by multi-drug resistant germs upon ICU admission and assess the severity of the disease in comparison to patients infected with susceptible bacteria. Ultimately, we aim to develop and validate a clinical tool to assist physicians in selecting the appropriate antibiotic for their patients
Methods: An observational prospective study with a control group will be conducted, including all patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and with a positive microbiologic result. Patients with isolation of only susceptible bacteria will be allocated to the control group, while patients with MDR bacteria will be assigned to the study group, referred to as the MDR group. The data to be collected will include sex, age, previous use of antibiotics in the last three months, previous hospital admissions, previous isolation of MDR germs, sensitivity profile of the isolated germs, severity of disease (measured by SAPS 3), presence of sepsis diagnosis at admission, length of stay in the ICU, and 28-day mortality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi drug resistant group | – | Diagnostic Test: Identification o Multi Drug Resistant BacteriaAll critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug resistant bacteria isolation : |
| Multi sensible bacteria group | – | Diagnostic Test: Identification o Multi Drug Resistant BacteriaAll critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug sensible bacteria isolation : |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and with a positive microbiologic result.
Key inclusion criteria (1 listed)
- All patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and a microbiological positive result for bacteria
Key exclusion criteria (4 listed)
- Patients with results considered as contamination according to the institutional protocol.
- Surgical wound and bloodstream infections.
- Microbiological isolation of only fungi.
- Vigilance cultures, such as anal, rectal, nasal, and axillary swabs.
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 |
|---|---|---|
| Identification o Multi Drug Resistant BacteriaIdentification o Multi Drug Resistant Bacteria | Diagnostic test | Multi drug resistant group, Multi sensible bacteria group |
Primary outcome
Determine risk factors for multi-drug resistant germs in ICU admission.
Time frame: 28 days
Analysis of resistance profile of germs and patient's comorbidities to determine the risk factors for drug resistance.
3 secondary outcomes
Mortality between control and case group
Time frame: 28 days
Mean LOS of each group
Time frame: 28 days
Severity between groups using SAPS 3
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 34446092Niederman MS, Baron RM, Bouadma L, Calandra T, Daneman N, DeWaele J, Kollef MH, Lipman J, Nair GB. Initial antimicrobial management of sepsis. Crit Care. 2021 Aug 26;25(1):307. doi: 10.1186/s13054-021-03736-w.
- Results publication: PubMed 34605781Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
- Results publication: PubMed 33045353Bassetti M, Rello J, Blasi F, Goossens H, Sotgiu G, Tavoschi L, Zasowski EJ, Arber MR, McCool R, Patterson JV, Longshaw CM, Lopes S, Manissero D, Nguyen ST, Tone K, Aliberti S. Systematic review of the impact of appropriate versus inappropriate initial antibiotic therapy on outcomes of patients with severe bacterial infections. Int J Antimicrob Agents. 2020 Dec;56(6):106184. doi: 10.1016/j.ijantimicag.2020.106184. Epub 2020 Oct 9.
- Results publication: PubMed 28067711Kalil AC, Johnson DW, Lisco SJ, Sun J. Early Goal-Directed Therapy for Sepsis: A Novel Solution for Discordant Survival Outcomes in Clinical Trials. Crit Care Med. 2017 Apr;45(4):607-614. doi: 10.1097/CCM.0000000000002235.
- Results publication: PubMed 28345952Liu VX, Fielding-Singh V, Greene JD, Baker JM, Iwashyna TJ, Bhattacharya J, Escobar GJ. The Timing of Early Antibiotics and Hospital Mortality in Sepsis. Am J Respir Crit Care Med. 2017 Oct 1;196(7):856-863. doi: 10.1164/rccm.201609-1848OC.
- Results publication: PubMed 27112143Wong D, Wong T, Romney M, Leung V. Comparative effectiveness of beta-lactam versus vancomycin empiric therapy in patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. Ann Clin Microbiol Antimicrob. 2016 Apr 26;15:27. doi: 10.1186/s12941-016-0143-3.
- Results publication: PubMed 35162062Fernandez-Martinez NF, Carcel-Fernandez S, De la Fuente-Martos C, Ruiz-Montero R, Guzman-Herrador BR, Leon-Lopez R, Gomez FJ, Guzman-Puche J, Martinez-Martinez L, Salcedo-Leal I. Risk Factors for Multidrug-Resistant Gram-Negative Bacteria Carriage upon Admission to the Intensive Care Unit. Int J Environ Res Public Health. 2022 Jan 18;19(3):1039. doi: 10.3390/ijerph19031039.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi Drug Resistant Bacteria, run by José Raimundo Araujo de Azevedo.
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 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PAULO BEZERRA, MD (+55 98988748865, drpaulobezerra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine risk factors for multi-drug resistant germs in ICU admission. (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 NCT05983861, which also lists 7 linked publications.
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 9 Aug 2023.