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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02098226
Recruitment Status : Unknown
Verified February 2015 by Bruker Daltonics.
Recruitment status was:  Recruiting
First Posted : March 27, 2014
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):
Bruker Daltonics

Tracking Information
First Submitted Date March 25, 2014
First Posted Date March 27, 2014
Last Update Posted Date February 6, 2015
Study Start Date September 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2014)
Substantial equivalence of MBT-CA with sequencing concerning determination of the respective bacteria and yeasts [ Time Frame: half a year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02098226 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts
Official Title Method Comparison Protocol: MALDI Biotyper-Clinical Applications (MBT-CA) Phase 2
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

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with infections from certain yeasts, Gram positive or certain Gram negative bacteria (see Further Information / Target microorganisms of study)
Condition Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 26, 2014)
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
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)

Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
Administrative Information
NCT Number NCT02098226
Other Study ID Numbers BDAL-2013-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bruker Daltonics
Study Sponsor Bruker Daltonics
Collaborators Not Provided
Investigators Not Provided
PRS Account Bruker Daltonics
Verification Date February 2015