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

Infection Clinical Trial

Official title:

Method Comparison Protocol: MALDI Biotyper-Clinical Applications (MBT-CA) Phase 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02098226
• Other study ID #: BDAL-2013-001
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2014
• Last updated: February 5, 2015
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: February 2015
• Source: Bruker Daltonics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection

Locations

Country	Name	City	State
Germany	Bruker Daltonik GmbH	Bremen

Sponsors (1)

Lead Sponsor	Collaborator
Bruker Daltonics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substantial equivalence of MBT-CA with sequencing concerning determination of the respective bacteria and yeasts		half a year	No