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

NCT01025180 | Terminated Phase 4 DMC

• 1 other identifier: PCT-F-2005-10
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Severe Sepsis

Keywords

safety; Procalcitonin; PCT; SOFA; Sepsis; Antibiotic; Strategy; SIRS; severe sepsis without obvious infection

Outcome Measures

Primary Outcomes (1)

• rate of patients undergoing antibiotic treatment at D5.

  at D5

Secondary Outcomes (1)

• evolution of the SOFA score between D0, D3 and D5.

  D30

Study Arms (2)

Procalcitonin level

OTHER

duration of the antibiotic treatment guided by procalcitonin level

Other: Procalcitonin level

physician's appreciation

NO INTERVENTION

duration of the antibiotic treatment based on physician's appreciation

Interventions

Procalcitonin level OTHER

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

Procalcitonin level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalized in resuscitation ward
• severe sepsis symptomatology
• at least 2 SIRS criteria
• no infectious etiology detected
• at least one organ deficiency

You may not qualify if:

• the presence of a pathogen agent or infectious centre clearly identified
• pregnancy
• burned
• patients with therapeutic limitation
• recent surgery
• secondary neutropenia

Sponsors & Collaborators

• Brahms France: lead

Study Sites (9)

ICU in J.Minjoz hospital

Besançon, 25030, France

Location

ICU in Avicenne hospital

Bobigny, 93009, France

Location

ICU in Ambroise Paré hospital

Boulogne, 92100, France

Location

ICU in Raymond Poincaré hospital

Garches, 92380, France

Location

ICU in André Boulloche hospital

Montbéliard, 25200, France

Location

ICU in Centre hospitalier général

Mulhouse Belfort, 90000, France

Location

ICU in St Etienne hospital

Saint-Etienne, 42055, France

Location

ICU in Purpan hospital

Toulouse, 31059, France

Location

ICU in Rangueil hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Sepsis

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Officials

• Djillali Annane, Professor

  Raymond Poincaré hospital Garches-France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 3, 2009
• Study Start: December 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 6, 2010

Record last verified: 2009-12

Locations

FR (9)