Pulmonary TBNCT00212550
Evaluation of the Practice of Three Morning Sputa on Separate Days for Diagnosis of Mtb
An observational study of Pulmonary TB, run by NYU Langone Health at 1 site in United States.
Trial summary
Obtain sputum smears within one day to rule out TB Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary TB
- What is being tested?
- Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2012
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: TB patients
Who may be able to join
- All subjects admitted to Bellevue Hospital for evaluation of possible TB
Who cannot join
- Unable to produce spontaneous or induced sputum
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU School of Medicine Division of Pulmonary and Critical Care
New York, New York, 10016
About this study
Obtain sputum smears within one day to rule out TB
- Conditions
- Pulmonary TB
- Being tested
- Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.Procedure or surgery
Sputum induction
| Study group | Role | What they receive |
|---|---|---|
| TB diagnosis | Not described Receives: Procedure: Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionFeb 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TBStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rany Condos, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212550
- Sponsor's protocol ID
- 9250-04B
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Practice of Three Morning Sputa on Separate Days for Diagnosis of Mtb
- ClinicalTrials.gov ID
- NCT00212550
- Acronym / sponsor ID
- 9250-04B
- Conditions
- Pulmonary TB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 Sep 2005 (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.
Obtain sputum smears within one day to rule out TB
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB diagnosis | – | Procedure: Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- TB patients
Key inclusion criteria (1 listed)
- All subjects admitted to Bellevue Hospital for evaluation of possible TB
Key exclusion criteria (1 listed)
- Unable to produce spontaneous or induced sputum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.Sputum induction | Procedure or surgery | TB diagnosis |
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 31 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
Rany Condos, MD principal investigator
NYU School of Medicine
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 Pulmonary TB, run by NYU Langone Health at 1 site 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 1 inclusion and 1 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 31 Mar 2016. 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 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.
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 31 Mar 2016.