Ignite Creation Date:
2024-05-06 @ 1:00 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03908632
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2019-03-27
Brief Title:
An Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis in Persons Aged 14 Years Presenting With Community Acquired Pneumonia CAP in Endemic Areas SAnds-PPC
Sponsor:
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
None
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITH_DNA
Bio Spec Description:
Venous blood samples approximately 10 mL to determine Coccidioides antibodies for entry will be performed locally at the sites for Step 1 Day 1 and if negative this will be repeated at Day 22 Erythrocyte sedimentation rate ESR high sensitivity C-reactive protein hsCRP and procalcitonin will be measured on Step 1 Day 1 or if enrolled directly into Step 2 at Step 2 Day 1 Total blood volume for subjects participating only in Step 1 will be up to 65 ml 95 mL for subjects consenting to additional sample collection for future use Total blood volume collected per participant who participates in Step 1 and Step 2 is up to 95 mL up to 155 mL for subjects consenting to additional sample collection for future use Volumes may be higher for subjects with additional clinic visits after Step 2 Visit 06 due to persistent or disseminated disease
Enrollment Count:
651
Enrollment Type:
ACTUAL
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Case-Control |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 55212 |
Who Masked List: