LRTITailoredTNCT02025699
Prospective Study to Characterize Host-pathogen Related Factors in Hospitalized and ED Patients With LRTI and/or Sepsis
An observational study of LRTI and Sepsis, run by MeMed Diagnostics Ltd. at 1 site in Israel.
Trial summary
The TAILORED-Treatment consortium was established to develop new tools aimed to increase the effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults. Read more about this study
- Who is it for?
- Ages 1 month to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- LRTI, Sepsis, Fungal Infections
- How many people
- 1,200 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Sep 2016
- 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 1 month to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Eligible subjects aged one month of age and older from both genders that attend the hospital or the ED due to a suspected respiratory infections and/or sepsis (onset of symptoms ≤8 days prior to recruitment) or due to a non-infectious disease. These subjects are expected to fall into one of the following categories: 1. Patients with an acute bacterial infection 2. Patients with an acute viral infection 3. Patients with an acute mixed co-infection (bacterial and viral) 4. Patients with a fungal infection 5. Patients with an undetermined disease etiology 6. Patients with a non-infectious disease (control group) Patients from subgroups 1-6 will also be classified based on the presence or absence of sepsis or severe sepsis.
Who may be able to join
- : Patients who are at least one month old will be eligible for inclusion.
- The LRTI disease group should also fulfill the following criteria:
- Presence of two or more of the following signs of respiratory distress:
- Tachypnea, Chest cough, Nasal flaring, Retractions, Rales, Expiratory wheeze and/or decreased breath sounds
- The Sepsis group should also fulfill the following criteria:
- Sepsis will be defined as a combination of a systemic inflammatory response syndrome (SIRS) due to infectious agent. SIRS will be determined according to published criteria (the International Sepsis Definitions Conference, 2001) based on (in adults):
Show all 12Show fewer
- Heart rate (higher than 90/min) Respiratory rate (higher than 20/min or PaCO2 lower than 32 mmHg) Core body temperature (higher than 38°C or lower than 36°C) White blood cell count (higher than 12,000 cells/ µl or lower than 4,000/ µl)
- SIRS is defined as at least two of the above criteria, one of which must be abnormal temperature or white blood cell count
- Severe sepsis is defined as sepsis plus one of the following:
- Cardiovascular failure Acute respiratory distress syndrome Two or more other organ failure As normal physiological variables are different for children, the SIRS criteria are defined separately for children under 18. SIRS and severe sepsis criteria per age group are defined in details in the "Population/Inclusion criteria" section below, according to guidelines of the International Pediatric Sepsis Consensus Conference (2005).
- The non-infectious disease group will include:
- Patients with a non-infectious disease. Children in this group can only be included when blood sampling for this study can be combined with blood sampling as part of standard of care.
Who cannot join
- An episode of febrile infection during the past 3 weeks
- A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- Presence of obvious alternative causes of respiratory distress, such as heart failure or pneumothorax
- Patients with a nosocomial LRTI (developed > 3days after hospitalization)
- Post-transplant patients
- Congenital immune deficiency (CID)
Show all 11Show fewer
- Active hematological malignancy
- Current treatment with immune-suppressive or immune-modulating therapies including:
- Chemotherapy, Radiotherapy or High dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks, Monoclonal antibody or Intravenous IgG (IVIG), Cyclosporine, Anti-TNF agents, Interferon (of all kinds)
- Other severe illnesses that affect life expectancy and quality of life such as: Moderate to severe psychomotor retardation Moderate to severe congenital metabolic disorder
- In children only: Other severe illnesses affecting life expectancy less than one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Multi-center, Prospective Study to Characterize Novel pathogen-and Host-related Factors in Hospitalized Patients and Patients on the Emergency Department Presenting With Lower Respiratory Tract Infections and/or Sepsis.
The TAILORED-Treatment consortium was established to develop new tools aimed to increase the effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults.
Read the detailed description
The TAILORED-Treatment consortium was established to develop new tools aimed to increase the effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults.
In reality, targeted antimicrobial therapy can most effectively be achieved by utilizing personalized data to facilitate a tailored and optimized approach to individual patient treatment. This can best be achieved by utilizing knowledge gained from both host-centered and pathogen-centered parameters during health and disease. Unfortunately, these parameters have traditionally, tended to be measured independently (for example using microbial culture or PCR-based methods for microbial detection, or measurement of the immune response to infections and/or blood-based biomarkers in the host), and used on an ad hoc basis without careful integration for the best treatment of the patient. However, recent advances in the development of high-throughput and sensitive molecular-based technologies, on-line internet database access tools, and bioinformatics analysis, now means that the goal of personalized medicine and treatment is in sight. Unfortunately however, there currently exists a technological gap between recent state-of-the-art methodologies (for example with respect to gaining new insights into novel host-pathogen interactions) and laboratory-to-bedside results to benefit patients, physicians and society as a whole. The TAILORED-Treatment project is designed to bridge this technological gap in order to generate novel insights and innovations that are readily exploitable for the maximum benefit of multiple stakeholders in the field of personalized medicine and infectious diseases.
- Conditions
- LRTI, Sepsis, Fungal Infections, Bacteremia, Fever Without Source
- Medical subject headings
- Sepsis, Mycoses, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LRTI | Not described | |
| Sepsis | Not described | |
| Non-Infectious disease group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis
The assesment of the sensitivity and specificity of a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis
Measured: 4 years
Secondary outcomes (6)
Sensitivity and specificity ≥70% for host-related individual biomarkers, in differentiating bacterial or viral or fungal etiology from other etiologies in patients with LRTI and/or sepsis
To identify host-related individual biomarkers that have sensitivity and specificity of ≥70% in differentiating bacterial or viral or fungal etiology from other etiologies in patients with LRTI and/or sepsis
Measured: 4 years
Sensitivity and specificity ≥70% for sets of blood biomarkers, in differentiating Gram positive or Gram negative or atypical etiology from other disease etiologies in patients with LRTI and/or sepsis
To identify sets of blood biomarkers with sensitivity and specificity of ≥70% in differentiating Gram positive or Gram negative or atypical etiology from other disease etiologies in patients with LRTI and/or sepsis
Measured: 4 years
Monitoring the temporal dynamics concentrations of blood biomarkers levels during the course of disease in patients with LRTI and/or sepsis
To monitor the temporal dynamics concentrations of blood bio-markers levels during the course of disease in patients with LRTI and/or sepsis including determination of the time required to reach peak levels and the time required to return to normal values.
Measured: 4 years
A list of significant bacterial microbiome components that are associated with poor or favorable clinical outcome in patients with LRTI and/or sepsis
To create a list of significant bacterial microbiome components that are associated with poor or favorable clinical outcome in patients with LRTI and/or sepsis
Measured: 4 years
Sensitivity and specificity ≥70% for liquid chromatography-mass spectrometry and lipid-based Protein Immobilization proteomics-based rapid detection technique in identifying pathogens in clinical samples of patients with LRTI and/or sepsis
To achieve sensitivity and specificity of ≥70% for liquid chromatography-mass spectrometry (LC-MS/MS) and lipid-based Protein Immobilization (LPI) proteomics-based rapid detection technique in identifying pathogens in clinical samples of patients with LRTI and/or sepsis
Measured: 4 years
To build a web-based application that provides physicians with a recommended antimicrobial treatment based on patients clinical, molecular and biochemical data.
To create an open web-based application that provides physicians with a recommended antimicrobial treatment based on a patient clinical, molecular and biochemical data.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionSep 2016
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 LRTIStudies 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
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Kfir Oved, Dr., Study director, MeMed Diagnostics Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025699
- Sponsor's protocol ID
- MM-1004-TT
- Acronym
- TailoredT
- Status last verified
- Jan 2017
- First submitted
- 23 Dec 2013
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
van Houten CB, Oved K, Eden E, Cohen A, Engelhard D, Boers S, Kraaij R, Karlsson R, Fernandez D, Gonzalez E, Li Y, Stubbs A, Moore ERB, Hays JP, Bont LJ. Observational multi-centre, prospective study to characterize novel pathogen-and host-related factors in hospitalized patients with lower respiratory tract infections and/or sepsis - the "TAILORED-Treatment" study. BMC Infect Dis. 2018 Aug 7;18(1):377. doi: 10.1186/s12879-018-3300-9.
PubMed 30086729
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Multi-center, Prospective Study to Characterize Novel pathogen-and Host-related Factors in Hospitalized Patients and Patients on the Emergency Department Presenting With Lower Respiratory Tract Infections and/or Sepsis.
- ClinicalTrials.gov ID
- NCT02025699
- Acronym / sponsor ID
- TailoredT / MM-1004-TT
- Conditions
- LRTI, Sepsis, Fungal Infections, Bacteremia, Fever Without Source
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Jan 2014 (estimated)
- 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 TAILORED-Treatment consortium was established to develop new tools aimed to increase the effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults.
Detailed description
The TAILORED-Treatment consortium was established to develop new tools aimed to increase the effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults.
In reality, targeted antimicrobial therapy can most effectively be achieved by utilizing personalized data to facilitate a tailored and optimized approach to individual patient treatment. This can best be achieved by utilizing knowledge gained from both host-centered and pathogen-centered parameters during health and disease. Unfortunately, these parameters have traditionally, tended to be measured independently (for example using microbial culture or PCR-based methods for microbial detection, or measurement of the immune response to infections and/or blood-based biomarkers in the host), and used on an ad hoc basis without careful integration for the best treatment of the patient. However, recent advances in the development of high-throughput and sensitive molecular-based technologies, on-line internet database access tools, and bioinformatics analysis, now means that the goal of personalized medicine and treatment is in sight. Unfortunately however, there currently exists a technological gap between recent state-of-the-art methodologies (for example with respect to gaining new insights into novel host-pathogen interactions) and laboratory-to-bedside results to benefit patients, physicians and society as a whole. The TAILORED-Treatment project is designed to bridge this technological gap in order to generate novel insights and innovations that are readily exploitable for the maximum benefit of multiple stakeholders in the field of personalized medicine and infectious diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LRTI | – | – |
| Sepsis | – | – |
| Non-Infectious disease group | – | – |
Who may qualify
- Ages
- 1 month to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible subjects aged one month of age and older from both genders that attend the hospital or the ED due to a suspected respiratory infections and/or sepsis (onset of symptoms ≤8 days prior to recruitment) or due to a non-infectious disease. These subjects are expected to fall into one of the following categories: 1. Patients with an acute bacterial infection 2. Patients with an acute viral infection 3. Patients with an acute mixed co-infection (bacterial and viral) 4. Patients with a fungal infection 5. Patients with an undetermined disease etiology 6. Patients with a non-infectious disease (control group) Patients from subgroups 1-6 will also be classified based on the presence or absence of sepsis or severe sepsis.
Key inclusion criteria (12 listed)
- : Patients who are at least one month old will be eligible for inclusion.
- Tachypnea, Chest cough, Nasal flaring, Retractions, Rales, Expiratory wheeze and/or decreased breath sounds
- Sepsis will be defined as a combination of a systemic inflammatory response syndrome (SIRS) due to infectious agent. SIRS will be determined according to published criteria (the International Sepsis Definitions Conference, 2001) based on (in adults):
- Heart rate (higher than 90/min) Respiratory rate (higher than 20/min or PaCO2 lower than 32 mmHg) Core body temperature (higher than 38°C or lower than 36°C) White blood cell count (higher than 12,000 cells/ µl or lower than 4,000/ µl)
- SIRS is defined as at least two of the above criteria, one of which must be abnormal temperature or white blood cell count
Key exclusion criteria (11 listed)
- An episode of febrile infection during the past 3 weeks
- A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- Presence of obvious alternative causes of respiratory distress, such as heart failure or pneumothorax
- Patients with a nosocomial LRTI (developed > 3days after hospitalization)
- Post-transplant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity for a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis
Time frame: 4 years
The assesment of the sensitivity and specificity of a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis
6 secondary outcomes
Sensitivity and specificity ≥70% for host-related individual biomarkers, in differentiating bacterial or viral or fungal etiology from other etiologies in patients with LRTI and/or sepsis
Time frame: 4 years
Sensitivity and specificity ≥70% for sets of blood biomarkers, in differentiating Gram positive or Gram negative or atypical etiology from other disease etiologies in patients with LRTI and/or sepsis
Time frame: 4 years
Monitoring the temporal dynamics concentrations of blood biomarkers levels during the course of disease in patients with LRTI and/or sepsis
Time frame: 4 years
A list of significant bacterial microbiome components that are associated with poor or favorable clinical outcome in patients with LRTI and/or sepsis
Time frame: 4 years
Sensitivity and specificity ≥70% for liquid chromatography-mass spectrometry and lipid-based Protein Immobilization proteomics-based rapid detection technique in identifying pathogens in clinical samples of patients with LRTI and/or sepsis
Time frame: 4 years
To build a web-based application that provides physicians with a recommended antimicrobial treatment based on patients clinical, molecular and biochemical data.
Time frame: 4 years
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 13 Jan 2017.
- Derived from this study: PubMed 30086729van Houten CB, Oved K, Eden E, Cohen A, Engelhard D, Boers S, Kraaij R, Karlsson R, Fernandez D, Gonzalez E, Li Y, Stubbs A, Moore ERB, Hays JP, Bont LJ. Observational multi-centre, prospective study to characterize novel pathogen-and host-related factors in hospitalized patients with lower respiratory tract infections and/or sepsis - the "TAILORED-Treatment" study. BMC Infect Dis. 2018 Aug 7;18(1):377. doi: 10.1186/s12879-018-3300-9.
- Individual participant dataSharing planned: No
Related trials for LRTI
RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
RecruitingPhase 3
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
Sepsis
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.
Kfir Oved, Dr. study director
MeMed Diagnostics Ltd.
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 LRTI and Sepsis, run by MeMed Diagnostics Ltd. at 1 site in Israel.
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 12 inclusion and 11 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 13 Jan 2017. 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 Israel. 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?
Sensitivity and specificity for a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis (time frame: 4 years). 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 NCT02025699, 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 13 Jan 2017.