Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection

Study Overview
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Brief Summary
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A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification. The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre. This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group) 140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified. The primary outcome is the rate of patients undergoing antibiotic treatment at D5. Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5. Duration of patient enrollment is 30 days.

Official Title
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Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection

Conditions
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Severe Sepsis

Intervention / Treatment
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* Other: Procalcitonin level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospitalized in resuscitation ward severe sepsis symptomatology at least 2 SIRS criteria no infectious etiology detected at least one organ deficiency Exclusion Criteria: the presence of a pathogen agent or infectious centre clearly identified pregnancy burned patients with therapeutic limitation recent surgery secondary neutropenia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Procalcitonin level<br>duration of the antibiotic treatment guided by procalcitonin level | Other: Procalcitonin level<br>* The duration of antibiotic treatment is based on PCT level: < 0.25 ng/ml: antibiotic should be stopped 0.25 < PCT <0.5: antibiotic prescription is not recommended > 0.5 ng/ml: antibiotic should be used<br>|
| No Intervention: physician's appreciation<br>duration of the antibiotic treatment based on physician's appreciation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients undergoing antibiotic treatment at D5. |  | at D5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evolution of the SOFA score between D0, D3 and D5. |  | D30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, Procalcitonin, PCT, SOFA, Sepsis, Antibiotic, Strategy, SIRS, severe sepsis without obvious infection