FilariasisNCT01628497
Exhaled NO Testing in Filariasis
An observational study of Filariasis, run by Vanderbilt University Medical Center at 1 site in Guyana.
Trial summary
This study is looking at the difference in exhaled nitric oxide levels in patients with and without laboratory evidence of filariasis. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Filariasis
- How many people
- 96 participants
- Where
- 1 siteGuyana
- Study dates
- May 2012to Mar 2014
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study subjects: * recruited from patients with a chief complaint of wheezing, asthma or cough. * assessed by a physician prior to consideration for enrollment into the study * screened by the study investigator after evaluation by the physician Control subjects: Controls will be matched with cases by gender, age and region of residence. They will have non-emergent complaints without respiratory symptoms.
Who may be able to join
- Age 6 years or older of either gender
- Patients presenting with pulmonary symptoms a. Confirmed or suspected asthma patients: i. Patients presenting with symptoms consistent with an acute exacerbation of asthma, including:
- 1. Wheezing 2. Shortness of breath 3. Chest tightness 4. Cough ii. Disposition to the asthma room after triage and physician evaluation (disposition to other areas of the A\&E allowed if due to no available space in the asthma room) iii. Patients are potentially eligible with or without a past history of health care provider diagnosed asthma iv. Patients are potentially eligible regardless of the number of previous episodes of wheezing (i.e. patients with a first episode of bronchospasm are potentially eligible) v. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if:
- They have a dry cough (no production of purulent sputum)
- They have bronchospasm as manifested by wheezing or need for salbutamol (albuterol) breathing treatments vi. Patients with wheezing are not eligible if they:
- 1. Have purulent sputum production 2. Have known or suspected:
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- Tuberculosis b. Immunodeficiency c. Congestive heart failure d. Foreign body aspiration b. Patients presenting with a chief complaint of cough: i. Potentially eligible patients will have a cough of greater than one week (seven days) duration ii. Asthma room disposition is not required for these subjects iii. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if:
- 1. They have a dry cough (no production of purulent sputum) iv. Patients with cough are not eligible if:
- Have purulent sputum production
- Have known or suspected:
- Tuberculosis
- Immunodeficiency
- Congestive heart failure
- Foreign body aspiration
- Patients will be medically stable at the time of the consent process (see exclusion criteria below)
- A minimum of 2 years of continuous residence in Guyana at the time of enrollment, exclusive of short trips out of the country (at least 21 of previous 24 months physically in Guyana)
- English speaking
Who cannot join
- Patients less than 6 years of age
- Patients who do not consent to the study
- Children (<18 years) without a parent/guardian present
- Prisoners
- Patients who appear to be medically or psychologically unstable or felt to be otherwise inappropriate for study enrollment, in the opinion of the investigator or any treating health care provider. This determination will be made on an individual basis, but some of the general criteria to be used in making this determination will be:
- The patient appears to be in significant pain ii. The patient appears acutely ill - severe respiratory distress, diaphoretic, altered mental status, active bleeding, actively vomiting, etc.
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- Those with respiratory difficulty to the point they cannot speak in complete sentences iv. Chief complaint of sexual assault v. The patient appears acutely intoxicated vi. The patient displays agitated, nervous, restless, or other behavior suggestive of an uncontrolled psychiatric emergency
- Patients with pulmonary findings felt to be secondary to congestive heart failure, foreign body, bacterial pneumonia, tuberculosis or other clearly defined cause
- Non-English speaking patients
- Patients without at least 2 years of residence (exclusive of short trips abroad, total of 21 of 24 previous months physically in Guyana) in Guyana at the time of enrollment
Trial locations and contacts
1 site in 1 country.
Guyana1 site
Georgetown Public Hospital Corporation
Georgetown, Demerara-Mahaica
About this study
This study is looking at the difference in exhaled nitric oxide levels in patients with and without laboratory evidence of filariasis.
- Conditions
- Filariasis
- Medical subject headings
- Filariasis
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 |
|---|---|---|
| Positive filariasis test | Those testing positive for filariasis | |
| Filariasis negative | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FilariasisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628497
- Sponsor's protocol ID
- Fil-01
- Status last verified
- Apr 2017
- First submitted
- 22 Jun 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled NO Testing in Filariasis
- ClinicalTrials.gov ID
- NCT01628497
- Acronym / sponsor ID
- Fil-01
- Conditions
- Filariasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Jun 2012 (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 study is looking at the difference in exhaled nitric oxide levels in patients with and without laboratory evidence of filariasis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive filariasis test | – | –Those testing positive for filariasis |
| Filariasis negative | – | – |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study subjects: * recruited from patients with a chief complaint of wheezing, asthma or cough. * assessed by a physician prior to consideration for enrollment into the study * screened by the study investigator after evaluation by the physician Control subjects: Controls will be matched with cases by gender, age and region of residence. They will have non-emergent complaints without respiratory symptoms.
Key inclusion criteria (17 listed)
- Age 6 years or older of either gender
- Patients presenting with pulmonary symptoms a. Confirmed or suspected asthma patients: i. Patients presenting with symptoms consistent with an acute exacerbation of asthma, including:
- 1. Wheezing 2. Shortness of breath 3. Chest tightness 4. Cough ii. Disposition to the asthma room after triage and physician evaluation (disposition to other areas of the A\&E allowed if due to no available space in the asthma room) iii. Patients are potentially eligible with or without a past history of health care provider diagnosed asthma iv. Patients are potentially eligible regardless of the number of previous episodes of wheezing (i.e. patients with a first episode of bronchospasm are potentially eligible) v. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if:
- They have a dry cough (no production of purulent sputum)
- They have bronchospasm as manifested by wheezing or need for salbutamol (albuterol) breathing treatments vi. Patients with wheezing are not eligible if they:
Key exclusion criteria (10 listed)
- Patients less than 6 years of age
- Patients who do not consent to the study
- Children (<18 years) without a parent/guardian present
- Prisoners
- Patients who appear to be medically or psychologically unstable or felt to be otherwise inappropriate for study enrollment, in the opinion of the investigator or any treating health care provider. This determination will be made on an individual basis, but some of the general criteria to be used in making this determination will be:
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
Not reported in the source record.
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 7 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Filariasis, run by Vanderbilt University Medical Center at 1 site in Guyana.
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 17 inclusion and 10 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guyana. 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.
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 7 Apr 2017.