Evaluation of the Practice of Three Morning Sputa on Sepa... | NCT00212550

Studies
Evaluation of the Practice of Three Morning Sputa on Separate Days for Diagnosis of Mtb

NCT00212550

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Mar 31, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Pulmonary TB

Interventions

Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Feb 2010Actual

Completion Date

Jan 2012Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TB diagnosis			Procedure: Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.	Procedure	Sputum induction	TB diagnosis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects admitted to Bellevue Hospital for evaluation of possible TB

Exclusion Criteria:

Unable to produce spontaneous or induced sputum

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

TB patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rany Condos, MD	NYU School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU School of Medicine Division of Pulmonary and Critical Care		New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014397	Tuberculosis, Pulmonary

Ancestor Terms

ID	Term
D014376	Tuberculosis
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided