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

B·R·A·H·M·S

Status and phase: Terminated; Phase 4

Conditions: Severe Sepsis

Treatments: Other: Procalcitonin level

Study type: Interventional

Funder types: Industry

Identifiers

NCT01025180

PCT-F-2005-10

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Procalcitonin level

Other group

Description:

duration of the antibiotic treatment guided by procalcitonin level

Treatment:

Other: Procalcitonin level

physician's appreciation

No Intervention group

Description:

duration of the antibiotic treatment based on physician's appreciation