Early Diagnosis of Candidiasis in Premature Infants (Candida)
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| ClinicalTrials.gov Identifier: NCT00109525 |
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Recruitment Status :
Completed
First Posted : April 29, 2005
Last Update Posted : March 22, 2019
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| Condition or disease |
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| Infection Candida Candidiasis Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature |
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.
| 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 |
- Probability of invasive candidiasis based on new assay results [ Time Frame: Until discharge ]
- Determine test performance of clinical predictive model [ Time Frame: Until discharge ]
- Determine test performance (sensitivity and specificity) of polymerase chain reaction (PCR) testing [ Time Frame: Until discharge ]
- Determine test performance of Beta-glucan assay [ Time Frame: Until discharge ]
- Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of blood samples [ Time Frame: Until discharge ]
- Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of urine samples [ Time Frame: Until discharge ]
- Determine test performance of the blood culture [ Time Frame: Until discharge ]
- Determine test performance of the lumbar puncture (cell count, protein, glucose, and culture) [ Time Frame: Until discharge ]
- Determine test performance of tracheal aspirates [ Time Frame: Until discharge ]
- Determine test performance of urine cultures [ Time Frame: Until discharge ]
- Compare clinical predictive model performance to neonatologist clinical judgment [ Time Frame: Until discharge ]
- Determine incidence of end-organ damage in neonates with candidemia [ Time Frame: Until discharge ]
- Determine resistance patterns of organisms isolated [ Time Frame: Until discharge ]
- Determine molecular epidemiology of candidemia [ Time Frame: Until discharge ]
- Determine genetic expression of organism virulence factors [ Time Frame: Until discharge ]
- Neurodevelopmental outcome [ Time Frame: 18-22 months corrected age ]
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| Ages Eligible for Study: | 3 Days to 120 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
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
Show 20 study locations
| 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 |
Publications of Results:
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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 |
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Candidiasis Premature Birth Birth Weight Infections Obstetric Labor, Premature |
Obstetric Labor Complications Pregnancy Complications Body Weight Mycoses Bacterial Infections and Mycoses |