AzTrials
AzTrials

Lower Respiratory Tract InfectionNCT02093247

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

An observational study of Lower Respiratory Tract Infection, run by Hadassah Medical Organization.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is Observational multi-center, prospective study to characterize novel pathogen- and host-related factors in hospitalized patients and patients in the Emergency Department (ED) presenting with lower respiratory tract infections (LRTI) and/or sepsis.The Study's objective is to develop a novel… Read more about this study

Who is it for?
Ages 1 month to 75 years
Conditions the study is for
Lower Respiratory Tract Infection
How many people
Not given
Where
No sites listed yet
Study dates
Jun 2014to Jul 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 75 years
  • All sexes
  • No healthy volunteers
  • 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 (whose onset of symptoms began ≤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. Children in group 6 can only be included when blood sampling for this study can be combined with blood sampling as part of standard of care.

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:
  • 1.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 10Show 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.

About this study

This study is Observational multi-center, prospective study to characterize novel pathogen- and host-related factors in hospitalized patients and patients in the Emergency Department (ED) presenting with lower respiratory tract infections (LRTI) and/or sepsis.The Study's objective is to develop a novel multi-parametric diagnostic model for the management of patients with LRTI and/or sepsis that will be based on novel pathogen- and host-related factors.

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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 (2)

  1. 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

  2. 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.

  1. First posted20 Mar 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJul 2016 (estimated)

Resources

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT02093247
Sponsor's protocol ID
0006-14-HMO
Status last verified
Mar 2014
First submitted
3 Mar 2014
Last updated
20 Mar 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Respiratory Tract Infection, run by Hadassah Medical Organization.

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 10 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 20 Mar 2014. 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?

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 ≥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). 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 NCT02093247.

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 20 Mar 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in