Pulmonary TuberculosisNCT00517231
Cytokines and Acute Phase Reactants as Markers of Pulmonary Tuberculosis Treatment
An observational study of Pulmonary Tuberculosis, run by UPECLIN HC FM Botucatu Unesp.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Tuberculosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Jun 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Mycobacterium tuberculosis infection
Who cannot join
- all other granulomatous or neoplastic diseases
About this study
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.
Read the 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
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Pulmonary tuberculosis, Mycobacterium tuberculosis, Cytokines, Acute Phase Response, Treatment
- Medical subject headings
- Tuberculosis, Pulmonary, Acute-Phase Reaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startJun 2005
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: The investigator left the research center and the study was not carried out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Jussara Marcondes-Machado, PHD, Principal investigator, Botucatu School of Medicine - Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517231
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-pre02
- Status last verified
- Jul 2015
- First submitted
- 14 Aug 2007
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokines and Acute Phase Reactants as Markers of Pulmonary Tuberculosis Treatment
- ClinicalTrials.gov ID
- NCT00517231
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-pre02
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Pulmonary tuberculosis, Mycobacterium tuberculosis, Cytokines, Acute Phase Response, Treatment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The investigator left the research center and the study was not carried out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jun 2005
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 16 Aug 2007 (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.
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.
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of Mycobacterium tuberculosis infection
Key exclusion criteria (1 listed)
- all other granulomatous or neoplastic diseases
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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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.
Jussara Marcondes-Machado, PHD principal investigator
Botucatu School of Medicine - Unesp
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculosis, run by UPECLIN HC FM Botucatu Unesp.
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: withdrawn, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Jul 2015.