CoccidioidomycosisNCT03908632
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)
An observational study of Coccidioidomycosis and Pneumonia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 99 years
- Conditions the study is for
- Coccidioidomycosis, Pneumonia
- How many people
- 651 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Feb 2019to 5 Dec 2023
- 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 14 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Step 1 Subject Inclusion Criteria:
- 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.*
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- 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.
- Step 2 Subject Inclusion Criteria:
- 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.**
- 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.
Who cannot join
- Step 1 Subject Exclusion Criteria:
- 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.
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- Step 2 Subject Exclusion Criteria:
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Kaiser Permanente Chester Avenue Medical Offices - Pulmonology
Bakersfield, California, 93301
Kern Medical Center
Bakersfield, California, 93306-4018
UCSF Fresno Center for Medical Education and Research - Clinical Research Center
Fresno, California, 93701
Kaiser Permanente Antelope Valley Medical Offices - Infectious Diseases
Lancaster, California, 93534
Banner - University Medical Center Advanced Lung Disease Clinic - Phoenix
Phoenix, Arizona, 85006
The University of Arizona - Banner University Medical Center Tucson Campus - Tucson
Tucson, Arizona, 85724-0001
About this study
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.
Read the detailed description
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. The secondary objectives are divided into two categories. For subjects with CAP in coccidioidomycosis endemic areas the secondary objectives are: 1) To determine demographic, clinical and laboratory factors that predict PPC; 2) To describe the practice of empiric antifungal treatment of subjects with CAP. For subjects with confirmed primary pulmonary coccidioidomycosis the secondary objectives are: 1) To describe the clinical course of primary pulmonary coccidioidomycosis from earliest presentation; 2) To assess the demographic, clinical, laboratory and treatment predictors of the clinical course of primary pulmonary coccidioidomycosis; 3) To describe the practice of antifungal treatment of subjects with confirmed primary pulmonary coccidioidomycosis; 4) To compare the outcomes of antifungal therapy vs. no therapy for primary pulmonary coccidioidomycosis as measured by clinical signs and symptoms, functional scores of health and well-being and ability to participate in social roles and activities, time missed from school and work, dissemination, and mortality.
- Conditions
- Coccidioidomycosis, Pneumonia
- Keywords
- Community Acquired Pneumonia, Endemic Areas, Observational Study, Primary Pulmonary Coccidioidomycosis
- Medical subject headings
- Coccidioidomycosis, Pneumonia, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with primary pulmonary coccidioidomycosis (PPC) among subjects with Community Acquired Pneumonia CAP) in Step 1
Measured: Day 1 through Day 22
Secondary outcomes (37)
Associations between chest radiograph and antifungal treatment for PPC, Step 2
Measured: 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
Measured: Day 1 through Day 730
Associations between severity and antifungal treatment for PPC, Step 2
Measured: 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
Measured: Day 1 through Day 730
Compare disease severity score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Measured: Day 1 through Day 365
Compare mortality rates for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Measured: Day 1 through Day 365
Compare percent of subjects that develop persistent or disseminated PPC for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Measured: Day 85 through Day 730
Compare SAnds-PPC score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Measured: Day 1 through Day 730
Compare time missed from school and work for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Measured: Day 1 through Day 180
Descriptive statistics of subjects' demographics in Step 1
Measured: Day 1
Descriptive statistics of subjects' Erythrocyte Sedimentation Rate (ESR) in Step 1
Measured: Day 1
Descriptive statistics of subjects' High sensitivity C-reactive protein (hsCRP) in Step 1
Measured: Day 1
Descriptive statistics of subjects' Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis (SAnds-PPC) in Step 1
Measured: Day 1
Descriptive statistics of subjects' procalcitonin in Step 1
Measured: Day 1
Descriptive statistics of subjects' serologic titers in Step 1
Measured: Day 1
Frequency of prescription of antifungal therapy prescribed for Community Acquired Pneumonia (CAP) for Step 1
Measured: Day 1 through Day 22
Frequency of prescription of antifungal therapy prescribed for primary pulmonary coccidioidomycosis (PPC) for Step 2
Measured: Day 1 through Day 730
Mean of change in chest radiograph findings score as a part of standard of care, Step 2
Measured: From 4 to 8 weeks after Initial chest x-ray date
Mean of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Mean of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Measured: Day 180 through Day 365
Mean of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Mean of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Measured: Day 180 through Day 365
Mean of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Median of change in chest radiograph findings score as a part of standard of care, Step 2
Measured: From 4 to 8 weeks after Initial chest x-ray date
Median of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Median of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Measured: Day 180 through Day 365
Median of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Median of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Measured: Day 180 through Day 365
Median of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Quartiles of change in chest radiograph findings score as a part of standard of care, Step 2
Measured: From 4 to 8 weeks after Initial chest x-ray date
Quartiles of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Quartiles of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Measured: Day 180 through Day 365
Quartiles of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Quartiles of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Measured: Day 180 through Day 365
Quartiles of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Measured: Day 1 through Day 85
Summary statistics for PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Measured: Day 1 through Day 365
Summary statistics for the mental component summary (MCS) and the physical component summary (PCS) scores of the SF-12v2 instrument for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Measured: Day 1 through Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start14 Feb 2019
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccidioidomycosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908632
- Sponsor's protocol ID
- 14-1053
- Status last verified
- 25 Jul 2022
- First submitted
- 27 Mar 2019
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03908632
- Acronym / sponsor ID
- 14-1053
- Conditions
- Coccidioidomycosis, Pneumonia
- Keywords
- Community Acquired Pneumonia, Endemic Areas, Observational Study, Primary Pulmonary Coccidioidomycosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 9 Apr 2019 (actual)
- 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 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.
Detailed description
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. The secondary objectives are divided into two categories. For subjects with CAP in coccidioidomycosis endemic areas the secondary objectives are: 1) To determine demographic, clinical and laboratory factors that predict PPC; 2) To describe the practice of empiric antifungal treatment of subjects with CAP. For subjects with confirmed primary pulmonary coccidioidomycosis the secondary objectives are: 1) To describe the clinical course of primary pulmonary coccidioidomycosis from earliest presentation; 2) To assess the demographic, clinical, laboratory and treatment predictors of the clinical course of primary pulmonary coccidioidomycosis; 3) To describe the practice of antifungal treatment of subjects with confirmed primary pulmonary coccidioidomycosis; 4) To compare the outcomes of antifungal therapy vs. no therapy for primary pulmonary coccidioidomycosis as measured by clinical signs and symptoms, functional scores of health and well-being and ability to participate in social roles and activities, time missed from school and work, dissemination, and mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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.*
Key exclusion criteria (11 listed)
- 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.
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
Proportion of subjects with primary pulmonary coccidioidomycosis (PPC) among subjects with Community Acquired Pneumonia CAP) in Step 1
Time frame: Day 1 through Day 22
37 secondary outcomes
Associations between chest radiograph and antifungal treatment for PPC, Step 2
Time frame: 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
Time frame: Day 1 through Day 730
Associations between severity and antifungal treatment for PPC, Step 2
Time frame: 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
Time frame: Day 1 through Day 730
Compare disease severity score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 365
Compare mortality rates for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 365
Compare percent of subjects that develop persistent or disseminated PPC for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 85 through Day 730
Compare SAnds-PPC score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 730
Compare time missed from school and work for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 180
Descriptive statistics of subjects' demographics in Step 1
Time frame: Day 1
Descriptive statistics of subjects' Erythrocyte Sedimentation Rate (ESR) in Step 1
Time frame: Day 1
Descriptive statistics of subjects' High sensitivity C-reactive protein (hsCRP) in Step 1
Time frame: Day 1
Descriptive statistics of subjects' Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis (SAnds-PPC) in Step 1
Time frame: Day 1
Descriptive statistics of subjects' procalcitonin in Step 1
Time frame: Day 1
Descriptive statistics of subjects' serologic titers in Step 1
Time frame: Day 1
Frequency of prescription of antifungal therapy prescribed for Community Acquired Pneumonia (CAP) for Step 1
Time frame: Day 1 through Day 22
Frequency of prescription of antifungal therapy prescribed for primary pulmonary coccidioidomycosis (PPC) for Step 2
Time frame: Day 1 through Day 730
Mean of change in chest radiograph findings score as a part of standard of care, Step 2
Time frame: From 4 to 8 weeks after Initial chest x-ray date
Mean of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Mean of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Mean of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Mean of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Mean of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Median of change in chest radiograph findings score as a part of standard of care, Step 2
Time frame: From 4 to 8 weeks after Initial chest x-ray date
Median of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Median of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Median of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Median of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Median of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Quartiles of change in chest radiograph findings score as a part of standard of care, Step 2
Time frame: From 4 to 8 weeks after Initial chest x-ray date
Quartiles of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Quartiles of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Quartiles of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Quartiles of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Quartiles of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Summary statistics for PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 365
Summary statistics for the mental component summary (MCS) and the physical component summary (PCS) scores of the SF-12v2 instrument for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 365
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 19 Jan 2024.
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Not yet recruitingPhase 2
A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis Treated With Olorofim Plus Baseline Standard of Care or Placebo Plus Baseline Standard of Care
Coccidioidomycosis, Disseminated Fungal Infection
Not yet recruitingPhase 2
Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
Coccidioidomycosis, Blastomycosis
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coccidioidomycosis and Pneumonia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 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 20 inclusion and 11 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Proportion of subjects with primary pulmonary coccidioidomycosis (PPC) among subjects with Community Acquired Pneumonia CAP) in Step 1 (time frame: Day 1 through Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2024.