Cytokines and Acute Phase Reactants as Markers of Pulmona... | NCT00517231

Studies
Cytokines and Acute Phase Reactants as Markers of Pulmonary Tuberculosis Treatment

NCT00517231

Sponsor

UPECLIN HC FM Botucatu Unesp

Status

Withdrawn

Last Update Posted

Jul 7, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Pulmonary Tuberculosis

Interventions

Not provided

Countries

Not provided

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The investigator left the research center and the study was not carried out

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Aug 14, 2007

First Submission Date that Met QC Criteria

Aug 14, 2007

First Posted Date

Aug 16, 2007Estimated

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

Jul 6, 2015

Last Update Posted Date

Jul 7, 2015Estimated

Name	Class
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

Detailed Description

Tuberculosis is a highly prevalent chronic infectious disease caused by Mycobacterium tuberculosis. Cytokines are important biological mediators that regulate immune and inflammatory responses against the bacilli, witch include the acute phase response. Besides this, it becomes essential to determine markers of healing lesions, once this is currently carried out based on the clinical, radiological, and negative bacterioscopy. The propose of this work was to evaluate the production of IFN- γ in cell supernatants of peripheral blood mononuclear cells (PBMC) culture, TNF-α, IL-10 and TGF-b in cell supernatants of monocytes (MO) culture and biochemical (total proteins, albumin, globulin, α-1-acid glycoprotein and C-reactive protein) and hematological (VHS) serum parameters before and after 3 and 6 months of therapy

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

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of Mycobacterium tuberculosis infection

Exclusion Criteria:

all other granulomatous or neoplastic diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jussara Marcondes-Machado, PHD	Botucatu School of Medicine - Unesp	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014397	Tuberculosis, Pulmonary
D000210	Acute-Phase Reaction

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