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Intensive Care Med. 2017 Nov;43(11):1613-1625. doi: 10.1007/s00134-017-4766-4. Epub 2017 Apr 3.

Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial.

Collaborators (186)

Lefort A, Mantz J, Pease S, Lavagna L, Nicolas-Chanoine MH, Leflon V, Marcon E, Ruimy R, Andremont A, Lebras J, Iung B, Regnier B, Yeni P, Montravers P, Mourvillier B, Ilic-Habensus E, Talbi NEA, Lasocki S, Bouscary D, Mira JP, Grimaldi D, Marin N, Doloy A, Poyart C, Scherrer E, Chambon-Pautas C, Cook F, Mekontso-Dessap A, Schortgen F, Chedevergne K, Vernant JP, Gauvin-Bodin L, Trouillet JL, Chastre J, Bricaire F, Brossier F, Jarlier V, Dheder N, Nieszkowska A, Datry A, Fekkar A, Buffet P, Mazier R, Brun S, Meyssonnier V, Isnard F, Baudel JL, Meynard JL, Petit JC, Lalande V, Roux P, Raffoux E, Ribaud P, Das V, Schlemmer B, Azoulay E, Chimot L, Molina JM, Ponscarme D, Pavie J, Simon F, Casin I, Menotti J, Gruson D, Bessède E, Guilhon E, Accoceberry I, Millet P, Bébéar C, Berthoux C, Tonnelier JM, Garre M, Hery-Arnaud G, Payan C, Nevez G, Timsit JF, Cahn JY, Brion JP, Le Beau B, Courby S, Pelloux H, Maurin M, Epaulard O, Hamidfar R, Berthon C, Coiteux V, Terriou L, Nseir S, Auffray JL, Jouet JP, Durocher A, Faure K, Clavel M, Camus D, Dugard A, Tisseuil C, Duchiron C, Ajzenberg D, Bordessoule D, Garnier F, François B, Ploy MC, Darde ML, Chaury MP, Giraud S, Jaccard A, Moreau S, Réménieras L, Touati M, Turlure P, Amiel JB, Pichon N, Postil D, Vignon P, Espinouse D, Jacques D, De Monbrison F, Grozel JM, Chomarat M, Gueugniaud PY, Sanogo R, Drancourt M, Fournier PE, Roux V, Delmer A, Himberlin C, Kolb B, Lé QH, Appriou M, Cousson J, Nazeyrollas P, Strady C, Dechamps C, Vernet V, Delmer A, Toubas D, Guyotat D, Auboyer C, Zeni F, Alamartine E, Cathebras P, Lucht F, Viallon A, Melis A, Ros A, Carricajo A, Devanlay C, Labruyere C, Vautrin C, Cazorla C, Tavernier E, Grattard F, Aubert G, Morel J, Cornillon J, Abba K, Flori P, Sung RTM, Pozzetto B, Schneider F, Hansmann Y, Herbrecht R, Jaulhac B, Piémont Y, Lestcher V, Colombat P, Senecal D, Garot D, Perrottin D, Besnier JM, Goudeau A, Lanotte P, Chandenier J, Baloul S, Corbel C, Dabbech M, Gaba M, Jozefowicz E, Lafaye M, Maugard F, Rabeuf R, Rabetrano H, Veerabudun K, Viallette C, Stahl JP, Delhaes L.

Author information

1
APHP-Lariboisière, Bacteriology Laboratory, 75010, Paris, France. emmanuelle.cambau@aphp.fr.
2
Univ Paris Diderot, Sorbonne Paris Cité, INSERM, UMR1137 IAME, 75018, Paris, France. emmanuelle.cambau@aphp.fr.
3
APHP-URC ECO, Créteil, France.
4
Université Paris Est, UFR de Médecine, 94010, Créteil, France.
5
APHP-Henri Mondor, Parasitology and Mycology Laboratory, 94010, Créteil, France.
6
APHP-Saint Louis, Parasitology and Mycology Laboratory, 75010, Paris, France.
7
Sorbonne Paris Cité, University Paris Diderot, Paris, France.
8
Molecular Mycology Unit, Institut Pasteur, National Reference Center of Invasive Mycoses and Antifungals, Paris, France.
9
APHP- Henri Mondor, Intensive Care Department, 94010, Créteil, France.
10
APHP- Henri Mondor, Haematology Department and University Paris-Est Créteil, 94010, Créteil, France.
11
APHP-Bichat, Centre d'investigation Clinique CIC 1425, INSERM UMR 1137 IAME, University Paris Diderot, 75018, Paris, France.
12
CHU Lille, Microbiology Institute, 59000, Lille, France.
13
Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service d'Anesthésie-Réanimation chirurgicale, Université de Strasbourg, FMTS, EA 3072, 67098, Strasbourg, France.
14
APHP-Henri Mondor, Public Health Department, 94010, Créteil, France.
15
University Paris Est (UPE), IMRB, CEpiA (Clinical Epidemiology and Ageing Unit, EA7376), 94010, Créteil, France.
16
APHP, Henri Mondor Hospital, Clinical Research Unit (URC Mondor), 94010, Créteil, France.

Abstract

PURPOSE:

Microbiological diagnosis (MD) of infections remains insufficient. The resulting empirical antimicrobial therapy leads to multidrug resistance and inappropriate treatments. We therefore evaluated the cost-effectiveness of direct molecular detection of pathogens in blood for patients with severe sepsis (SES), febrile neutropenia (FN) and suspected infective endocarditis (SIE).

METHODS:

Patients were enrolled in a multicentre, open-label, cluster-randomised crossover trial conducted during two consecutive periods, randomly assigned as control period (CP; standard diagnostic workup) or intervention period (IP; additional testing with LightCycler®SeptiFast). Multilevel models used to account for clustering were stratified by clinical setting (SES, FN, SIE).

RESULTS:

A total of 1416 patients (907 SES, 440 FN, 69 SIE) were evaluated for the primary endpoint (rate of blood MD). For SES patients, the MD rate was higher during IP than during CP [42.6% (198/465) vs. 28.1% (125/442), odds ratio (OR) 1.89, 95% confidence interval (CI) 1.43-2.50; P < 0.001], with an absolute increase of 14.5% (95% CI 8.4-20.7). A trend towards an association was observed for SIE [35.4% (17/48) vs. 9.5% (2/21); OR 6.22 (0.98-39.6)], but not for FN [32.1% (70/218) vs. 30.2% (67/222), P = 0.66]. Overall, turn-around time was shorter during IP than during CP (22.9 vs. 49.5 h, P < 0.001) and hospital costs were similar (median, mean ± SD: IP €14,826, €18,118 ± 17,775; CP €17,828, €18,653 ± 15,966). Bootstrap analysis of the incremental cost-effectiveness ratio showed weak dominance of intervention in SES patients.

CONCLUSION:

Addition of molecular detection to standard care improves MD and thus efficiency of healthcare resource usage in patients with SES. ClinicalTrials.gov registration number: NCT00709358.

KEYWORDS:

Aetiological source; Bacteremia; PCR; Sepsis

PMID:
28374097
PMCID:
PMC5633620
DOI:
10.1007/s00134-017-4766-4
[Indexed for MEDLINE]
Free PMC Article

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