Optimal Antibiotic Treatment of Moderate to Severe Bacterial Infections (CDSS)
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|ClinicalTrials.gov Identifier: NCT01338116|
Recruitment Status : Recruiting
First Posted : April 19, 2011
Last Update Posted : April 7, 2016
Severe bacterial infections are associated with mortality of about 30%. Patients with moderate to severe bacterial infections given early and appropriate empirical antibiotic treatment are at a lesser risk for a fatal outcome, with odds ratios ranging from 1.6 to 6.9. However only about 2/3 of patients worldwide are given early and appropriate empirical antibiotic treatment. About 40% of patients treated with antibiotics are given superfluous treatment.
TREAT is a computerized decision support system for antibiotic treatment in inpatients with common bacterial infections. TREAT is based on a state of the art stochastic model of the domain (a causal probabilistic network) and uses a cost benefit model for antibiotic treatment, including costs assigned to future resistance. It was tested in a randomized controlled trial in 3 countries and shown to improve the percentage of appropriate empirical antibiotic treatment while at the same time reduce hospital stay and the use of broad-spectrum antibiotics. The main limitation of TREAT is inherent in the limited information available within hours of presentation.
A second attractive approach to improve antibiotic treatment is to use techniques that do not depend on cultures, and thus shorten the time to identification of the pathogen to a few hours only. The LightCycler® SeptiFast test from Roche performs in vitro nucleic acid amplification test for pathogens causing bloodstream infections.
The purpose of the clinical trial is to show that the combined system TREAT/PCR assays will improve the outcome of inpatients with moderate to severe bacterial infections, while at the same time reducing the use of broad-spectrum antibiotics, with no or little additional costs. A secondary objective will be to assess the sensitivity and specificity of whole blood PCR, using TREAT as the reference standard.
|Condition or disease||Intervention/treatment||Phase|
|Community-associated Infections Health-care Acquired Infections Nosocomial Infections||Other: antibiotic treatment of by TREAT/PCR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimal Antibiotic Treatment of Moderate to Severe Bacterial Infections: Integration of PCR Technology and Medical Informatics/Artificial Intelligence|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Management by TREAT/PCR
The data available at the time of patient recruitment will be entered into TREAT. TREAT will provide advice for the empirical antibiotic treatment and unless the caring physician can justify a deviation from this recommendation, TREAT's recommendation will be implemented (yes or no antibiotic treatment and type of antibiotic). TREAT will also recommend whether a blood sample for PCR should be obtained. Blood will be collected aseptically and the test will be performed once daily between 1000AM-1700PM (results available daily at 1700 PM). PCR results and a PCR-revised TREAT recommendation will be reported to the patient's physician in charge and treatment will be revised accordingly.
Other: antibiotic treatment of by TREAT/PCR
Management by TREAT/PCR. The data available at the time of patient recruitment will be entered into TREAT. TREAT will provide advice for the empirical antibiotic treatment and unless the caring physician can justify a deviation from this recommendation, TREAT's recommendation will be implemented (yes or no antibiotic treatment and type of antibiotic). TREAT will also recommend whether a blood sample for PCR should be obtained. Blood will be collected aseptically and the test will be performed once daily between 1000AM-1700PM (results available daily at 1700 PM). PCR results and a PCR-revised TREAT recommendation will be reported to the patient's physician in charge and treatment will be revised accordingly. On day 2, when results of blood cultures and other cultures become available TREAT will be re-consulted and will issue a new recommendation based on the full microbiological investigation (negative and positive results).
No Intervention: Usual management
Patients will be managed by physicians as in regular clinical practice.
- Clinical success defined as 30-day survival and clinical stability on day 4 [ Time Frame: 30 days ]patient alive at day 30; on day 4: no fever, no intra-tracheal tube, hemodynamic stable, no vasopressor support, empirical treatment appropriate (and thus not changed).
- Appropriate empirical antibiotic treatment [ Time Frame: 48 hours ]Appropriateness of the antibiotic treatment given during the first 48 hours, before identification of the causative pathogen and its antibiotic susceptibilities
- Survival [ Time Frame: 30 days ]
- Hospital stay [ Time Frame: 30 days ]Length of hospital stay
- Antibiotic miuse of broad spectrum antibiotics and total costs of antibiotic treatment Superfluous antibiotic treatment [ Time Frame: 30 days ]Use of broad spectrum antibiotics and total costs of antibiotic treatment
- Costs [ Time Frame: 30 days ]Costs incurred during hospital stay
- Adverse events [ Time Frame: 30 days ]Allergy, nephrotoxicity, diarrhea, clostridium-difficile associated diarrhea and others
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338116
|Rabin Medical Center, Beilinson Hospital||Recruiting|
|Petah Tikvah, Israel, 49100|
|Contact: Laura Farbman 972-3-9377380 firstname.lastname@example.org|
|Contact: Mical Paul, Md 972-3-9377380 email@example.com|
|Principal Investigator: Mical Paul, MD|
|Principal Investigator: Leonard Leibovici, MD|
|Principal Investigator:||Mical Paul, MD||Rabin Medical Center|
|Principal Investigator:||Leonard Leibovici, Prof||Rabin Medical Center|