InfectionCandidaNCT00109525
Early Diagnosis of Candidiasis in Premature Infants
An observational study of Infection and Candida, run by NICHD Neonatal Research Network at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 120 daysHealthy volunteers can take part
- Conditions the study is for
- Infection, Candida, Candidiasis
- How many people
- 1,500 participants
- Where
- 20 sitesUnited States
- Study dates
- Mar 2004to Dec 2009
- 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 3 to 120 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants with birth weights ≤1,000 grams
Who may be able to join
- Infants born ≤1,000g birth weight
- Infants >72 hours old and less than 120 days old
Who cannot join
- Prior positive blood culture for Candida
- Evidence of congenital candidiasis
- Parents/legal guardians refuse consent
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Wake Forest University
Charlotte, North Carolina, 27157
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Miami
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06504
Stanford University
Palo Alto, California, 94304
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
University of Rochester
Rochester, New York, 14642
University of California at San Diego
San Diego, California, 92103-8774
About this study
Official title: Early Diagnosis of Nosocomial Candidiasis Study
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.
Read the 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.
- Conditions
- Infection, Candida, Candidiasis, Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- Keywords
- 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
- Medical subject headings
- Infections, Torulopsis, Candidiasis, Premature Birth, Mycoses, Pathologic Complete Response
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of invasive candidiasis based on new assay results
Measured: Until discharge
Determine test performance of clinical predictive model
Measured: Until discharge
Secondary outcomes (14)
Determine test performance (sensitivity and specificity) of polymerase chain reaction (PCR) testing
Measured: Until discharge
Determine test performance of Beta-glucan assay
Measured: Until discharge
Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of blood samples
Measured: Until discharge
Determine test performance of Gas Chromatography Mass Spectrometry for D-arabinitol of urine samples
Measured: Until discharge
Determine test performance of the blood culture
Measured: Until discharge
Determine test performance of the lumbar puncture (cell count, protein, glucose, and culture)
Measured: Until discharge
Determine test performance of tracheal aspirates
Measured: Until discharge
Determine test performance of urine cultures
Measured: Until discharge
Compare clinical predictive model performance to neonatologist clinical judgment
Measured: Until discharge
Determine incidence of end-organ damage in neonates with candidemia
Measured: Until discharge
Determine resistance patterns of organisms isolated
Measured: Until discharge
Determine molecular epidemiology of candidemia
Measured: Until discharge
Determine genetic expression of organism virulence factors
Measured: Until discharge
Neurodevelopmental outcome
Measured: 18-22 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2005 (estimated)
- Study startMar 2004
- Primary completionJul 2007
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Abbot R. Laptook, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandMichele C. Walsh, MD MS, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitalRonald N. Goldberg, MD, Principal investigator, Duke UniversityBarbara J. Stoll, MD, Principal investigator, Emory UniversityBrenda B. Poindexter, MD MS, Principal investigator, Indiana UniversityAbhik Das, PhD, Principal investigator, RTI InternationalKrisa P. Van Meurs, MD, Principal investigator, Stanford UniversityIvan D. Frantz III, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109525
- Sponsor's protocol ID
- NICHD-NRN-0030
- Other IDs
- UL1RR024139, UL1RR024160, M01RR016587, M01RR000030, M01RR000032, M01RR000039, M01RR000044, M01RR000054
- Acronym
- Candida
- Status last verified
- Mar 2019
- First submitted
- 28 Apr 2005
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Benjamin DK Jr, Stoll BJ, Gantz MG, Walsh MC, Sanchez PJ, Das A, Shankaran S, Higgins RD, Auten KJ, Miller NA, Walsh TJ, Laptook AR, Carlo WA, Kennedy KA, Finer NN, Duara S, Schibler K, Chapman RL, Van Meurs KP, Frantz ID 3rd, Phelps DL, Poindexter BB, Bell EF, O'Shea TM, Watterberg KL, Goldberg RN; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal candidiasis: epidemiology, risk factors, and clinical judgment. Pediatrics. 2010 Oct;126(4):e865-73. doi: 10.1542/peds.2009-3412. Epub 2010 Sep 27.
PubMed 20876174Adams-Chapman I, Bann CM, Das A, Goldberg RN, Stoll BJ, Walsh MC, Sanchez PJ, Higgins RD, Shankaran S, Watterberg KL, Duara S, Miller NA, Heyne RJ, Peralta-Carcelen M, Goldstein RF, Steichen JJ, Bauer CR, Hintz SR, Evans PW, Acarregui MJ, Myers GJ, Vohr BR, Wilson-Costello DE, Pappas A, Vaucher YE, Ehrenkranz RA, McGowan EC, Dillard RG, Fuller J, Benjamin DK Jr; Eunice Kennedy Shriver National Institutes of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome of extremely low birth weight infants with Candida infection. J Pediatr. 2013 Oct;163(4):961-7.e3. doi: 10.1016/j.jpeds.2013.04.034. Epub 2013 May 30.
PubMed 23726546Bliss JM, Wong AY, Bhak G, Laforce-Nesbitt SS, Taylor S, Tan S, Stoll BJ, Higgins RD, Shankaran S, Benjamin DK Jr; Candida Subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Candida virulence properties and adverse clinical outcomes in neonatal candidiasis. J Pediatr. 2012 Sep;161(3):441-447.e2. doi: 10.1016/j.jpeds.2012.02.051. Epub 2012 Apr 14.
PubMed 22504098Greenberg RG, Benjamin DK Jr, Gantz MG, Cotten CM, Stoll BJ, Walsh MC, Sanchez PJ, Shankaran S, Das A, Higgins RD, Miller NA, Auten KJ, Walsh TJ, Laptook AR, Carlo WA, Kennedy KA, Finer NN, Duara S, Schibler K, Ehrenkranz RA, Van Meurs KP, Frantz ID 3rd, Phelps DL, Poindexter BB, Bell EF, O'Shea TM, Watterberg KL, Goldberg RN, Smith PB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Empiric antifungal therapy and outcomes in extremely low birth weight infants with invasive candidiasis. J Pediatr. 2012 Aug;161(2):264-9.e2. doi: 10.1016/j.jpeds.2012.01.053. Epub 2012 Mar 15.
PubMed 22424952Wynn JL, Tan S, Gantz MG, Das A, Goldberg RN, Adams-Chapman I, Stoll BJ, Shankaran S, Walsh MC, Auten KJ, Miller NA, Sanchez PJ, Higgins RD, Cotten CM, Smith PB, Benjamin DK Jr; NICHD Neonatal Research Network. Outcomes following candiduria in extremely low birth weight infants. Clin Infect Dis. 2012 Feb 1;54(3):331-9. doi: 10.1093/cid/cir800. Epub 2011 Dec 5.
PubMed 22144537
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Nosocomial Candidiasis Study
- ClinicalTrials.gov ID
- NCT00109525
- Acronym / sponsor ID
- Candida / NICHD-NRN-0030
- Conditions
- Infection, Candida, Candidiasis, Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- Keywords
- NICHD Neonatal Research Network, Fungal Infection, Mycosis, Extremely Low Birth Weight (ELBW), Prematurity, Clinical Judgement, Polymerase chain reaction (PCR) testing, Beta-glucan assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Mar 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 120 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants with birth weights ≤1,000 grams
Key inclusion criteria (2 listed)
- Infants born ≤1,000g birth weight
- Infants >72 hours old and less than 120 days old
Key exclusion criteria (3 listed)
- Prior positive blood culture for Candida
- Evidence of congenital candidiasis
- Parents/legal guardians refuse consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Probability of invasive candidiasis based on new assay results
Time frame: Until discharge
Determine test performance of clinical predictive model
Time frame: Until discharge
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Results publication: PubMed 20876174Benjamin DK Jr, Stoll BJ, Gantz MG, Walsh MC, Sanchez PJ, Das A, Shankaran S, Higgins RD, Auten KJ, Miller NA, Walsh TJ, Laptook AR, Carlo WA, Kennedy KA, Finer NN, Duara S, Schibler K, Chapman RL, Van Meurs KP, Frantz ID 3rd, Phelps DL, Poindexter BB, Bell EF, O'Shea TM, Watterberg KL, Goldberg RN; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal candidiasis: epidemiology, risk factors, and clinical judgment. Pediatrics. 2010 Oct;126(4):e865-73. doi: 10.1542/peds.2009-3412. Epub 2010 Sep 27.
- Results publication: PubMed 23726546Adams-Chapman I, Bann CM, Das A, Goldberg RN, Stoll BJ, Walsh MC, Sanchez PJ, Higgins RD, Shankaran S, Watterberg KL, Duara S, Miller NA, Heyne RJ, Peralta-Carcelen M, Goldstein RF, Steichen JJ, Bauer CR, Hintz SR, Evans PW, Acarregui MJ, Myers GJ, Vohr BR, Wilson-Costello DE, Pappas A, Vaucher YE, Ehrenkranz RA, McGowan EC, Dillard RG, Fuller J, Benjamin DK Jr; Eunice Kennedy Shriver National Institutes of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome of extremely low birth weight infants with Candida infection. J Pediatr. 2013 Oct;163(4):961-7.e3. doi: 10.1016/j.jpeds.2013.04.034. Epub 2013 May 30.
- Results publication: PubMed 22504098Bliss JM, Wong AY, Bhak G, Laforce-Nesbitt SS, Taylor S, Tan S, Stoll BJ, Higgins RD, Shankaran S, Benjamin DK Jr; Candida Subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Candida virulence properties and adverse clinical outcomes in neonatal candidiasis. J Pediatr. 2012 Sep;161(3):441-447.e2. doi: 10.1016/j.jpeds.2012.02.051. Epub 2012 Apr 14.
- Results publication: PubMed 22424952Greenberg RG, Benjamin DK Jr, Gantz MG, Cotten CM, Stoll BJ, Walsh MC, Sanchez PJ, Shankaran S, Das A, Higgins RD, Miller NA, Auten KJ, Walsh TJ, Laptook AR, Carlo WA, Kennedy KA, Finer NN, Duara S, Schibler K, Ehrenkranz RA, Van Meurs KP, Frantz ID 3rd, Phelps DL, Poindexter BB, Bell EF, O'Shea TM, Watterberg KL, Goldberg RN, Smith PB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Empiric antifungal therapy and outcomes in extremely low birth weight infants with invasive candidiasis. J Pediatr. 2012 Aug;161(2):264-9.e2. doi: 10.1016/j.jpeds.2012.01.053. Epub 2012 Mar 15.
- Results publication: PubMed 22144537Wynn JL, Tan S, Gantz MG, Das A, Goldberg RN, Adams-Chapman I, Stoll BJ, Shankaran S, Walsh MC, Auten KJ, Miller NA, Sanchez PJ, Higgins RD, Cotten CM, Smith PB, Benjamin DK Jr; NICHD Neonatal Research Network. Outcomes following candiduria in extremely low birth weight infants. Clin Infect Dis. 2012 Feb 1;54(3):331-9. doi: 10.1093/cid/cir800. Epub 2011 Dec 5.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbot R. Laptook, MD principal investigator
Brown University, Women & Infants Hospital of Rhode Island
Michele C. Walsh, MD MS principal investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N. Goldberg, MD principal investigator
Duke University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Candida, run by NICHD Neonatal Research Network at 20 sites in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of invasive candidiasis based on new assay results (time frame: Until discharge). The study lists 2 primary outcomes in all. 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 NCT00109525, which also lists 5 linked publications.
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 22 Mar 2019.