Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts

NCT ID: NCT02098226

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-03-31

Brief Summary

The study objective is to confirm that the MBT-CA System identifies medically significant bacteria and yeasts from an isolated colony from any sample type processed by the clinical laboratory. For this purpose MBT-CA test results will be compared to bi-directional sequencing results.

Detailed Description

Bacteria or yeast isolates (1) fresh from primary culture plates, (2) collected directly from clinical samples, stored in the refrigerator or frozen or (3) well characterized organisms from a variety of contemporary culture collections will be included in the study. All organisms to be included in the study will be cultured on an agar medium prior to measurement.

Testing will be performed for various Gram negative and Gram positive bacteria and yeasts as outlined below. Several thousands of samples will be measured via MBT-CA systems based on MALDI-TOF MS technology (matrix assisted laser desorption ionisation time-of-flight mass spectrometry) at the test sites as fresh or frozen isolates of bacteria and yeasts. Lower prevalence organisms may be supplemented from banked culture collections.

The MBT-CA system uses an organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ≥ 2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and <2.00.

In the last step the samples are sent to a special site for sequencing. Finally, the respective sequencing results are compared with the MBT-CA results.

Target microorganisms of study:

1. Acinetobacter haemolyticus

2. Acinetobacter johnsonii

3. Acinetobacter junii

4. Actinomyces meyeri

5. Actinomyces neuii

6. Actinomyces odontolyticus

7. Actinomyces oris

8. Aerococcus urinae

9. Aerococcus viridans

10. Aeromonas salmonicida

11. Anaerococcus vaginalis

12. Bacteroides fragilis

13. Bacteroides uniformis

14. Bacteroides_ovatus group

15. Bacteroides_thetaiotaomicron group

16. Bacteroides_vulgatus group

17. Bordetella group[3]

18. Bordetella hinzii

19. Brevibacterium casei

20. Brevundimonas_diminuta group

21. Campylobacter coli

22. Campylobacter jejuni

23. Campylobacter ureolyticus

24. Candida albicans

25. Candida boidinii

26. Candida dubliniensis

27. Candida duobushaemulonii

28. Candida famata

29. Candida glabrata

30. Candida guilliermondii

31. Candida haemulonis

32. Candida inconspicua

33. Candida kefyr

34. Candida krusei

35. Candida lambica

36. Candida lipolytica

37. Candida lusitaniae

38. Candida metapsilosis

39. Candida norvegensis

40. Candida orthopsilosis

41. Candida parapsilosis

42. Candida pararugosa

43. Candida pelliculosa

44. Candida tropicalis

45. Candida valida

46. Capnocytophaga ochracea

47. Capnocytophaga sputigena

48. Chryseobacterium gleum

49. Chryseobacterium indologenes

50. Clostridium difficile

51. Clostridium perfringens

52. Corynebacterium amycolatum

53. Corynebacterium bovis

54. Corynebacterium diphtheriae

55. Corynebacterium glucuronolyticum

56. Corynebacterium jeikeium

57. Corynebacterium kroppenstedtii

58. Corynebacterium macginleyi

59. Corynebacterium minutissimum

60. Corynebacterium propinquum

61. Corynebacterium pseudodiphtheriticum

62. Corynebacterium riegelii

63. Corynebacterium tuberculostearicum

64. Corynebacterium ulcerans

65. Corynebacterium urealyticum

66. Corynebacterium xerosis

67. Corynebacterium_aurimucosum group

68. Corynebacterium_striatum group

69. Cronobacter_sakazakii group

70. Cryptococcus gattii

71. Cryptococcus neoformans_var_grubii

72. Cryptococcus neoformans_var_neoformans

73. Cupriavidus_pauculus group

74. Delftia_acidovorans group

75. Dermacoccus nishinomiyaensis

76. Edwardsiella tarda

77. Elizabethkingia_meningoseptica group

78. Enterobacter amnigenus

79. Enterococcus casseliflavus

80. Enterococcus faecalis

81. Enterococcus faecium

82. Enterococcus gallinarum

83. Enterococcus hirae

84. Enterococcus_avium group

85. Finegoldia magna

86. Fusobacterium canifelinum

87. Fusobacterium necrophorum

88. Fusobacterium nucleatum

89. Gardnerella vaginalis

90. Gemella haemolysans

91. Gemella sanguinis

92. Geotrichum candidum

93. Geotrichum capitatum

94. Granulicatella adiacens

95. Haemophilus haemolyticus

96. Haemophilus influenzae

97. Haemophilus_parahaemolyticus group

98. Kingella kingae

99. Kloeckera apiculata 100. Kocuria kristinae 101. Kytococcus sedentarius 102. Lactococcus garvieae 103. Lactococcus lactis 104. Leuconostoc mesenteroides 105. Macrococcus caseolyticus 106. Micrococcus luteus 107. Moraxella_sg_Moraxella nonliquefaciens 108. Myroides odoratimimus 109. Myroides odoratus 110. Oligella ureolytica 111. Oligella urethralis 112. Parabacteroides distasonis 113. Pediococcus pentosaceus 114. Peptoniphilus_harei group 115. Peptostreptococcus anaerobius 116. Pichia ohmeri 117. Plesiomonas shigelloides 118. Porphyromonas gingivalis 119. Prevotella bivia 120. Prevotella buccae 121. Prevotella denticola 122. Prevotella intermedia 123. Prevotella melaninogenica 124. Propionibacterium acnes 125. Pseudomonas stutzeri 126. Rhizobium radiobacter 127. Rothia aeria 128. Rothia dentocariosa 129. Rothia mucilaginosa 130. Saccharomyces cerevisiae 131. Serratia plymuthica 132. Serratia rubidaea 133. Staphylococcus aureus 134. Staphylococcus auricularis 135. Staphylococcus capitis 136. Staphylococcus caprae 137. Staphylococcus carnosus 138. Staphylococcus cohnii 139. Staphylococcus epidermidis 140. Staphylococcus equorum 141. Staphylococcus felis 142. Staphylococcus haemolyticus 143. Staphylococcus hominis 144. Staphylococcus lugdunensis 145. Staphylococcus pasteuri 146. Staphylococcus pettenkoferi 147. Staphylococcus pseudintermedius 148. Staphylococcus saccharolyticus 149. Staphylococcus saprophyticus 150. Staphylococcus schleiferi 151. Staphylococcus simulans 152. Staphylococcus vitulinus 153. Staphylococcus warneri 154. Streptococcus agalactiae 155. Streptococcus anginosus 156. Streptococcus constellatus 157. Streptococcus dysgalactiae 158. Streptococcus gallolyticus 159. Streptococcus gordonii 160. Streptococcus intermedius 161. Streptococcus lutetiensis 162. Streptococcus mutans 163. Streptococcus pneumoniae 164. Streptococcus pyogenes 165. Streptococcus salivarius 166. Streptococcus_mitis_oralis group 167. Sutterella wadsworthensis 168. Trichosporon asahii 169. Vibrio parahaemolyticus 170. Vibrio vulnificus

sg = subgenus sp=species var = variety

Conditions

Infection

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

-Patients with infections from certain yeasts, Gram positive or Gram negative bacteria (see Detailed Description)

Exclusion Criteria

-Patients without infections from the quoted microorganisms (see Detailed Description)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bruker Daltonics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bruker Daltonik GmbH

Bremen, City state Bremen, Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Markus Kostrzewa, Ph:D.

Role: primary

markus.kostrzewa@bruker.com

Jens Pfannkuche, Ph.D.

Role: backup

jens.pfannkuche@bruker.com

Other Identifiers

BDAL-2013-001

Identifier Type: -

Identifier Source: org_study_id