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InfectionNCT02098226

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

An observational study of Infection, run by Bruker Daltonics at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Infection
How many people
3,000 participants
Where
1 siteGermany
Study dates
Sep 2013to Mar 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with infections from certain yeasts, Gram positive or certain Gram negative bacteria (see Further Information / Target microorganisms of study)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting

  • Bruker Daltonik GmbH

    Bremen, Free Hanseatic City of Bremen, 28359

    Markus Kostrzewa, Ph:D., markus.kostrzewa@bruker.com

    Jens Pfannkuche, Ph.D., jens.pfannkuche@bruker.com

    Recruiting

Other trials in Germany

About this study

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

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.

Read the 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
Medical subject headings
Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Substantial equivalence of MBT-CA with sequencing concerning determination of the respective bacteria and yeasts

    Measured: half a year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2014
  4. Study completionMar 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02098226
Sponsor's protocol ID
BDAL-2013-001
Status last verified
Feb 2015
First submitted
25 Mar 2014
Last updated
6 Feb 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Infection, run by Bruker Daltonics at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substantial equivalence of MBT-CA with sequencing concerning determination of the respective bacteria and yeasts (time frame: half a year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02098226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.

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