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Early Diagnosis of Candidiasis in Premature Infants (Candida)

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ClinicalTrials.gov Identifier: NCT00109525
Recruitment Status : Completed
First Posted : April 29, 2005
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Brief Summary:
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately. 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth weights ≤1,000g; 100 of these infants later tested positive for candidiasis. Blood, urine, and lumbar puncture samples were collected whenever other specimens were obtained from participants for cultures. These samples are being tested using the new methods and compared with standard culture results. Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age.

Condition or disease
Infection Candida Candidiasis Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature

Detailed Description:

Candida species are a leading cause of infectious mortality in newborns with the incidence rates estimated at 4-18% in extremely low birth weight (ELBW) infants. 20-30% of these infants are likely to die. Because candida can invade virtually all body tissues (eyes, brain, heart, lung, liver, spleen, urinary tract, and joints), survivors of invasive Candida infections are at risk of blindness, developmental delays, and the need for surgical and other corrective procedures.

Time is of the essence in detecting and treating these infections, with infant mortality from candidiasis largely attributed to duration of time for cultures to become positive for Candida. Diagnosis of candidiasis is challenging - blood and urine tests are slow (taking up to 72 hours to complete) and inaccurate in many cases, showing negative results despite overwhelming disease in adults as well as children. These problems are likely made worse in neonates, with smaller amounts of blood available for testing and infections that often spread to tissues inaccessible for testing.

This observational study is evaluating the performance of new lab tests (beta-glucan assays, Gas Chromatography Mass Spectrometry for D-arabinitol, and polymerase chain reaction tests) compared to existing culture tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately.

In this study, 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth weights ≤1,000g by 72 hours of life; more than 100 of these infants later tested positive for candidiasis. In the larger cohort, whenever cultures of blood or urine were obtained, or a lumbar puncture was done, additional samples and clinical data were collected. These additional samples are being tested using the new techniques under investigation. No additional blood specimens were taken once participants had a positive blood culture for candida. Note: Test procedure reagents are being provided the Duke University laboratory by Cape Cod Incorporated and Rockeby; the Thrasher Research Fund is also providing support to the Duke University laboratory.

Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected age to evaluate potential early risk factors with long-term outcome.

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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Diagnosis of Nosocomial Candidiasis Study
Study Start Date : March 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections




Primary Outcome Measures :
  1. Probability of invasive candidiasis based on new assay results [ Time Frame: Until discharge ]
  2. Determine test performance of clinical predictive model [ Time Frame: Until discharge ]

Secondary Outcome Measures :
  1. Determine test performance (sensitivity and specificity) of polymerase chain reaction (PCR) testing [ Time Frame: Until discharge ]
  2. Determine test performance of Beta-glucan assay [ Time Frame: Until discharge ]
  3. Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of blood samples [ Time Frame: Until discharge ]
  4. Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of urine samples [ Time Frame: Until discharge ]
  5. Determine test performance of the blood culture [ Time Frame: Until discharge ]
  6. Determine test performance of the lumbar puncture (cell count, protein, glucose, and culture) [ Time Frame: Until discharge ]
  7. Determine test performance of tracheal aspirates [ Time Frame: Until discharge ]
  8. Determine test performance of urine cultures [ Time Frame: Until discharge ]
  9. Compare clinical predictive model performance to neonatologist clinical judgment [ Time Frame: Until discharge ]
  10. Determine incidence of end-organ damage in neonates with candidemia [ Time Frame: Until discharge ]
  11. Determine resistance patterns of organisms isolated [ Time Frame: Until discharge ]
  12. Determine molecular epidemiology of candidemia [ Time Frame: Until discharge ]
  13. Determine genetic expression of organism virulence factors [ Time Frame: Until discharge ]
  14. Neurodevelopmental outcome [ Time Frame: 18-22 months corrected age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Infants with birth weights ≤1,000 grams
Criteria

Inclusion Criteria:

  • Infants born ≤1,000g birth weight
  • Infants >72 hours old and less than 120 days old

Exclusion Criteria:

  • Prior positive blood culture for Candida
  • Evidence of congenital candidiasis
  • Parents/legal guardians refuse consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109525


Locations
Show Show 20 study locations
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Abbot R. Laptook, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Michele C. Walsh, MD MS Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Ronald N. Goldberg, MD Duke University
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Brenda B. Poindexter, MD MS Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P. Van Meurs, MD Stanford University
Principal Investigator: Ivan D. Frantz III, MD Tufts Medical Center
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: Neil N. Finer, MD University of California, San Diego
Principal Investigator: Kurt Schibler, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Edward F. Bell, MD University of Iowa
Principal Investigator: Shahnaz Duara, MD University of Miami
Principal Investigator: Kristi L. Watterberg, MD University of New Mexico
Principal Investigator: Dale L. Phelps, MD University of Rochester
Principal Investigator: Kathleen A. Kennedy, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: Pablo J. Sanchez, MD University of Texas, Southwestern Medical Center at Dallas
Principal Investigator: T. Michael O'Shea, MD MPH Wake Forest University
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Additional Information:
Publications of Results:

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Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT00109525    
Other Study ID Numbers: NICHD-NRN-0030
UL1RR024139 ( U.S. NIH Grant/Contract )
UL1RR024160 ( U.S. NIH Grant/Contract )
M01RR016587 ( U.S. NIH Grant/Contract )
M01RR000030 ( U.S. NIH Grant/Contract )
M01RR000032 ( U.S. NIH Grant/Contract )
M01RR000039 ( U.S. NIH Grant/Contract )
M01RR000044 ( U.S. NIH Grant/Contract )
M01RR000054 ( U.S. NIH Grant/Contract )
M01RR000059 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
M01RR000633 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR007122 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000080 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD040498 ( U.S. NIH Grant/Contract )
U10HD040521 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD053089 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD053119 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2005    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Fungal Infection
Mycosis
Extremely Low Birth Weight (ELBW)
Prematurity
Clinical Judgement
Polymerase chain reaction (PCR) testing
Beta-glucan assay
Mass Spectrometry
Lumbar puncture
Additional relevant MeSH terms:
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Candidiasis
Premature Birth
Birth Weight
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Body Weight
Mycoses