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)

NCT03908632 | Completed

• 1 other identifier: 14-1053
• Study Type: observational
• Target: 651
• Locations: 1 country
• Sites: 6

Brief Summary

This is an observational study in 750 individuals aged 14 years or older, diagnosed with Community Acquired Pneumonia (CAP) who meet all eligibility criteria in Coccidioides endemic regions. This study is designed to provide data on the prevalence of primary pulmonary coccidioidomycosis among persons presenting with CAP in endemic regions. Among individuals diagnosed with primary pulmonary coccidioidomycosis, we aim to describe the clinical course, predictors of the clinical course and compare the response to prescribed antifungal therapy versus no antifungal therapy. The hypothesis for patients with primary pulmonary coccidioidomycosis is that early treatment with antifungal therapy is effective in reducing the frequency, severity and associated adverse outcomes of infection with recently acquired coccidioidomycosis pneumonia. The study will be divided into Step 1 and Step 2. Step 1 will identify which subjects have primary pulmonary coccidioidomycosis based on the case definition for the protocol and Step 2 will follow subjects who meet the case definition and will observe their clinical management and clinical outcomes. Subjects will enroll in Step 1 within 28 days of symptom onset. In Step 1, blood work for serologic determination of Coccidioides infection will be drawn at the time of enrollment (Day 1), and again 21 days later if a positive result is not reported at Day 1. Subjects with a diagnosis of primary pulmonary coccidioidomycosis confirmed by positive serologic testing during Step 1 will enter Step 2 within 21 days of a positive test result; subjects with a negative serology at Day 1 and Day 22 will not be followed further. Subjects referred to the study after a diagnosis of primary pulmonary coccidioidomycosis confirmed by positive serologic testing will also be allowed to enter Step 2 directly within 21 days of a positive test result and within 7 weeks of symptom onset, as long as they meet study enrollment criteria. The primary objective is to assess the prevalence of primary pulmonary coccidioidomycosis (PPC) in subjects with community acquired pneumonia (CAP) in coccidioidomycosis endemic areas.

Conditions

Coccidioidomycosis; Pneumonia

Keywords

Community Acquired Pneumonia; Endemic Areas; Observational Study; Primary Pulmonary Coccidioidomycosis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with primary pulmonary coccidioidomycosis (PPC) among subjects with Community Acquired Pneumonia CAP) in Step 1

  Day 1 through Day 22

Secondary Outcomes (37)

• Associations between chest radiograph and antifungal treatment for PPC, Step 2

  Day 1 through Day 730

• Associations between Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis (SAnds-PPC) and antifungal treatment for PPC, Step 2

  Day 1 through Day 730

• Associations between severity and antifungal treatment for PPC, Step 2

  Day 1 through Day 730

• Compare change in chest radiograph findings score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2

  Day 1 through Day 730

• Compare disease severity score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2

  Day 1 through Day 365

Study Arms (2)

Step 1

Subjects 14 years or older diagnosed with Community Acquired Pneumonia (CAP) and positive serology for primary pulmonary coccidioidomycosis (PPC) will enroll in Step 1 within 14 days of symptom onset, n=750

Step 2

Subjects with a diagnosis of primary pulmonary coccidioidomycosis (PPC) confirmed by positive serologic testing during Step 1 will enter Step 2 within 21 days of their test collection date, n=200

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Step 1 will include at least 750 persons aged 14 and older diagnosed with community acquired pneumonia (CAP) in coccidioidomycosis endemic areas. Step 2 will involve at least 200 persons aged 14 and older with primary pulmonary coccidioidomycosis.

You may qualify if:

• Aged \> / = 14 years and presenting for clinical care in coccidioidomycosis endemic areas.
• Diagnosis of community acquired pneumonia (CAP) established by a health care provider.
• Pulmonary opacity on chest X-ray or computerized tomography (CT) scan consistent with CAP.
• Onset of symptoms related to current CAP diagnosis within 28 days prior to enrollment.
• Must be able to understand the study and provide informed consent.\*
• \*If aged \< 18 years, the parent(s) or guardian must be able to understand the study and provide informed consent, with the assent of the minor.
• Willing and able to comply with study procedures and complete study visits.
• Willing to allow access to medical records, and medical records are available to the study team.
• Aged \> / = 14 years
• Presence of at least one influenza-like sign or symptom (e.g. fever, chest pain, cough, myalgia, arthralgia, and headache.
• Onset of any symptoms no earlier than 7 weeks prior to enrollment into Step 2.
• Opacity/pleural effusion diagnosed by chest radiograph or computerized tomography (CT) scan .
• Positive result for any serologic test confirming coccidioidomycosis obtained within 21 days prior to enrollment into Step 2.\*
• \* The assays considered for this criterion are: coccidioidal immunoglobulin M (IgM) by immunodiffusion, enzyme immunoassay (EIA), latex agglutination or tube precipitin OR coccidioidal immunoglobulin G (IgG) by immunodiffusion, EIA, or complement fixation. The interpretation of positive or negative is per the reporting laboratory instructions
• Must be able to understand the study and provide informed consent.\*\*

You may not qualify if:

• Have documented microbiologically- or serologically-confirmed past infections with Coccidioides.\*
• \*An initial positive serologic test obtained within 21 days inclusive prior to enrollment is permissible.
• Hospitalization within 14 days prior to the onset of pneumonia symptoms.
• Presence of cavitary lung disease.
• Evidence of disseminated, extrathoracic disease.
• Have documented microbiologically- or serologically-confirmed past infections with Coccidioides.\*
• \*An initial positive serologic test obtained within 21 days inclusive prior to enrollment is permissible.
• Presence of cavitary lung disease.
• Evidence of disseminated, extrathoracic disease.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (6)

Banner - University Medical Center Advanced Lung Disease Clinic - Phoenix

Phoenix, Arizona, 85006, United States

Location

The University of Arizona - Banner University Medical Center Tucson Campus - Tucson

Tucson, Arizona, 85724-0001, United States

Location

Kaiser Permanente Chester Avenue Medical Offices - Pulmonology

Bakersfield, California, 93301, United States

Location

Kern Medical Center

Bakersfield, California, 93306-4018, United States

Location

UCSF Fresno Center for Medical Education and Research - Clinical Research Center

Fresno, California, 93701, United States

Location

Kaiser Permanente Antelope Valley Medical Offices - Infectious Diseases

Lancaster, California, 93534, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Coccidioidomycosis; Pneumonia; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 9, 2019
• Study Start: February 14, 2019
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: January 19, 2024

Record last verified: 2022-07-25

Locations

US (6)