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Fungal Infection Susceptibility

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 369 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Eligibility criteria expanded, about 30 words

    Publications: details revised at 14 of 15 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: Patients Patients must: 1. Have cryptococcosis as determined by information collected f [...] cords, telephone interviews, or from a referring physician: * histopathology showing cryptococci; or * culture of C. neoformans or C. gattii * a positive cryptococcal antigen in the serum and/or CSF, tog [...] ount and chemistry consistent with cryptococcal meningitis. 2. Be over the age of 18 years old. 3. Have a primary physician outside of the NIH. 4. Agree to undergo genetic testing that will include WES and h [...] SNP arrays as appropriate for possible WES linkage studies. 5. Allow samples to b [...] [...]

  2. Minor

    49 amendments

    49 re-verifications since 2025-05-03, no change to tracked fields

    v320-v368

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The protocol will be carried out in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and the following United States Code of Federal Regulations (CFR) applicable to clinical studies: 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812. NIH-funded investigators and study site staff who are responsible for the conduct, management, or oversight of NIH-funded studies have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form will be approved by the IRB; an IRB determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form. ...
Trial Details
NCT Number NCT00001352
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Cryptococcal Infection, Cryptococcal Pneumonia, Pulmonary Cryptococcosis, Cryptococcal Meningitis, Cryptococcosis
Enrollment 800 participants
Start Date
Updated on ClinicalTrials.gov