TuberculosisNCT00173433

Exogenous Reinfection of Tuberculosis in Taiwan

An observational study of Tuberculosis, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Tuberculosis
How many people: 150 participants
Where: 1 siteTaiwan
Study dates: Aug 2005to Jul 2006
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

culture-proven tuberculosis with recurrence

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University Hospital
Taipei, 100

Other trials in Taiwan

About this study

Official title: The Importance of Exogenous Reinfection in the Tuberculosis Endemic of Taiwan

we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of exogenous reinfection. First, we will identify the patients with TB relapse after complete treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.

Read the detailed description

Tuberculosis (TB) remains the most important infectious disease in the world. In Taiwan, the incidence of TB increased in recent years. The failure of control implies the necessity to reevaluate the epidemiology of Mycobacterium tuberculosis. It is widely thought that most cases of TB are caused by reactivation of a latent infection. Treatment programs have therefore focused on cure rates rather than tracking of additional cases. But recent studies showed that exogenous reinfection plays an important role in the development of TB. In addition, it seems that the higher the local incidence, the more important exogenous reinfection is. The question of exogenous reinfection versus endogenous reactivation has an impact on the distribution of resources for the prevention and treatment of TB. Based on these evidences, we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of exogenous reinfection. First, we will identify the patients with TB relapse after complete treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.

Conditions: Tuberculosis
Keywords: tuberculosis, relapse, reinfection, reactivation, dormancy, tuberculin skin test
Medical subject headings: Tuberculosis, Recurrence, Reinfection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00173433
Study group	Role	What they receive
Culture-confirmed relapse of TB		Patients who have a recurrent episode of culture-confirmed TB after completion of treatment for the first episode of culture-confirmed TB

What is being measured

The primary outcome is the main question the study is designed to answer.

relapse due to reinfection
proportion of patients with exogenous reinfection in those with relapse of TB
Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005Jul 2006

First posted15 Sep 2005 (estimated)
Study startAug 2005
Primary completionJul 2006
Study completionJul 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for TuberculosisStudies of the same condition, open and under way.
More trials run by National Taiwan University HospitalThe 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
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00173433
Sponsor's protocol ID: 9461700627
Status last verified: Dec 2014
First submitted: 12 Sep 2005
Last updated: 9 Dec 2014
Results posted: No

Publications

Bandera A, Gori A, Catozzi L, Degli Esposti A, Marchetti G, Molteni C, Ferrario G, Codecasa L, Penati V, Matteelli A, Franzetti F. Molecular epidemiology study of exogenous reinfection in an area with a low incidence of tuberculosis. J Clin Microbiol. 2001 Jun;39(6):2213-8. doi: 10.1128/JCM.39.6.2213-2218.2001.
PubMed 11376059
Behr MA, Warren SA, Salamon H, Hopewell PC, Ponce de Leon A, Daley CL, Small PM. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999 Feb 6;353(9151):444-9. doi: 10.1016/s0140-6736(98)03406-0.
PubMed 9989714
Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, Jasmer RM, Koppaka V, Menzies RI, O'Brien RJ, Reves RR, Reichman LB, Simone PM, Starke JR, Vernon AA; American Thoracic Society, Centers for Disease Control and Prevention and the Infectious Diseases Society. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med. 2003 Feb 15;167(4):603-62. doi: 10.1164/rccm.167.4.603. No abstract available.
PubMed 12588714
Caminero JA, Pena MJ, Campos-Herrero MI, Rodriguez JC, Afonso O, Martin C, Pavon JM, Torres MJ, Burgos M, Cabrera P, Small PM, Enarson DA. Exogenous reinfection with tuberculosis on a European island with a moderate incidence of disease. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):717-20. doi: 10.1164/ajrccm.163.3.2003070.
PubMed 11254530
Caminero JA, Pena MJ, Campos-Herrero MI, Rodriguez JC, Garcia I, Cabrera P, Lafoz C, Samper S, Takiff H, Afonso O, Pavon JM, Torres MJ, van Soolingen D, Enarson DA, Martin C. Epidemiological evidence of the spread of a Mycobacterium tuberculosis strain of the Beijing genotype on Gran Canaria Island. Am J Respir Crit Care Med. 2001 Oct 1;164(7):1165-70. doi: 10.1164/ajrccm.164.7.2101031.
PubMed 11673204
Cronin WA, Golub JE, Lathan MJ, Mukasa LN, Hooper N, Razeq JH, Baruch NG, Mulcahy D, Benjamin WH, Magder LS, Strickland GT, Bishai WR. Molecular epidemiology of tuberculosis in a low- to moderate-incidence state: are contact investigations enough? Emerg Infect Dis. 2002 Nov;8(11):1271-9. doi: 10.3201/eid0811.020261.
PubMed 12453355
Davies BH. Infectivity of tuberculosis. Thorax. 1980 Jul;35(7):481-2. doi: 10.1136/thx.35.7.481. No abstract available.
PubMed 7434308
Ellis BA, Crawford JT, Braden CR, McNabb SJ, Moore M, Kammerer S; National Tuberculosis Genotyping and Surveillance Network Work Group. Molecular epidemiology of tuberculosis in a sentinel surveillance population. Emerg Infect Dis. 2002 Nov;8(11):1197-209. doi: 10.3201/eid0811.020403.
PubMed 12453343
Garbe TR, Hibler NS, Deretic V. Isoniazid induces expression of the antigen 85 complex in Mycobacterium tuberculosis. Antimicrob Agents Chemother. 1996 Jul;40(7):1754-6. doi: 10.1128/AAC.40.7.1754.
PubMed 8807080
Garcia de Viedma D, Marin M, Hernangomez S, Diaz M, Ruiz Serrano MJ, Alcala L, Bouza E. Tuberculosis recurrences: reinfection plays a role in a population whose clinical/epidemiological characteristics do not favor reinfection. Arch Intern Med. 2002 Sep 9;162(16):1873-9. doi: 10.1001/archinte.162.16.1873.
PubMed 12196086
Glassroth J, Robins AG, Snider DE Jr. Tuberculosis in the 1980s. N Engl J Med. 1980 Jun 26;302(26):1441-50. doi: 10.1056/NEJM198006263022603. No abstract available.
PubMed 6990260
Jou NT, Yoshimori RB, Mason GR, Louie JS, Liebling MR. Single-tube, nested, reverse transcriptase PCR for detection of viable Mycobacterium tuberculosis. J Clin Microbiol. 1997 May;35(5):1161-5. doi: 10.1128/jcm.35.5.1161-1165.1997.
PubMed 9114400
Miller AC, Sharnprapai S, Suruki R, Corkren E, Nardell EA, Driscoll JR, McGarry M, Taber H, Etkind S. Impact of genotyping of Mycobacterium tuberculosis on public health practice in Massachusetts. Emerg Infect Dis. 2002 Nov;8(11):1285-9. doi: 10.3201/eid0811.020316.
PubMed 12453357
Pai SR, Actor JK, Sepulveda E, Hunter RL Jr, Jagannath C. Identification of viable and non-viable Mycobacterium tuberculosis in mouse organs by directed RT-PCR for antigen 85B mRNA. Microb Pathog. 2000 Jun;28(6):335-42. doi: 10.1006/mpat.2000.0353.
PubMed 10839970
Sharnprapai S, Miller AC, Suruki R, Corkren E, Etkind S, Driscoll J, McGarry M, Nardell E. Genotyping analyses of tuberculosis cases in U.S.- and foreign-born Massachusetts residents. Emerg Infect Dis. 2002 Nov;8(11):1239-45. doi: 10.3201/eid0811.020370.
PubMed 12453348

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tuberculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Importance of Exogenous Reinfection in the Tuberculosis Endemic of Taiwan
ClinicalTrials.gov ID: NCT00173433
Acronym / sponsor ID: 9461700627
Conditions: Tuberculosis
Keywords: tuberculosis, relapse, reinfection, reactivation, dormancy, tuberculin skin test
Study type: Observational
Recruitment status: Completed
Enrolment: 150 participants (estimated)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Study start: Aug 2005
Primary completion: Jul 2006 (actual)
Study completion: Jul 2006 (actual)
First posted: 15 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.

Detailed description

Study design

Number of arms: 1

Arm	Type	Receives
Culture-confirmed relapse of TB	–	–Patients who have a recurrent episode of culture-confirmed TB after completion of treatment for the first episode of culture-confirmed TB

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

culture-proven tuberculosis with recurrence

Key exclusion criteria (0 listed)

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

relapse due to reinfection
Time frame: 6 years
proportion of patients with exogenous reinfection in those with relapse of TB

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 9 Dec 2014.
Background: PubMed 11376059Bandera A, Gori A, Catozzi L, Degli Esposti A, Marchetti G, Molteni C, Ferrario G, Codecasa L, Penati V, Matteelli A, Franzetti F. Molecular epidemiology study of exogenous reinfection in an area with a low incidence of tuberculosis. J Clin Microbiol. 2001 Jun;39(6):2213-8. doi: 10.1128/JCM.39.6.2213-2218.2001.
Background: PubMed 9989714Behr MA, Warren SA, Salamon H, Hopewell PC, Ponce de Leon A, Daley CL, Small PM. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999 Feb 6;353(9151):444-9. doi: 10.1016/s0140-6736(98)03406-0.
Background: PubMed 12588714Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, Jasmer RM, Koppaka V, Menzies RI, O'Brien RJ, Reves RR, Reichman LB, Simone PM, Starke JR, Vernon AA; American Thoracic Society, Centers for Disease Control and Prevention and the Infectious Diseases Society. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med. 2003 Feb 15;167(4):603-62. doi: 10.1164/rccm.167.4.603. No abstract available.
Background: PubMed 11254530Caminero JA, Pena MJ, Campos-Herrero MI, Rodriguez JC, Afonso O, Martin C, Pavon JM, Torres MJ, Burgos M, Cabrera P, Small PM, Enarson DA. Exogenous reinfection with tuberculosis on a European island with a moderate incidence of disease. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):717-20. doi: 10.1164/ajrccm.163.3.2003070.
Background: PubMed 11673204Caminero JA, Pena MJ, Campos-Herrero MI, Rodriguez JC, Garcia I, Cabrera P, Lafoz C, Samper S, Takiff H, Afonso O, Pavon JM, Torres MJ, van Soolingen D, Enarson DA, Martin C. Epidemiological evidence of the spread of a Mycobacterium tuberculosis strain of the Beijing genotype on Gran Canaria Island. Am J Respir Crit Care Med. 2001 Oct 1;164(7):1165-70. doi: 10.1164/ajrccm.164.7.2101031.
Background: PubMed 12453355Cronin WA, Golub JE, Lathan MJ, Mukasa LN, Hooper N, Razeq JH, Baruch NG, Mulcahy D, Benjamin WH, Magder LS, Strickland GT, Bishai WR. Molecular epidemiology of tuberculosis in a low- to moderate-incidence state: are contact investigations enough? Emerg Infect Dis. 2002 Nov;8(11):1271-9. doi: 10.3201/eid0811.020261.
Background: PubMed 7434308Davies BH. Infectivity of tuberculosis. Thorax. 1980 Jul;35(7):481-2. doi: 10.1136/thx.35.7.481. No abstract available.
Background: PubMed 12453343Ellis BA, Crawford JT, Braden CR, McNabb SJ, Moore M, Kammerer S; National Tuberculosis Genotyping and Surveillance Network Work Group. Molecular epidemiology of tuberculosis in a sentinel surveillance population. Emerg Infect Dis. 2002 Nov;8(11):1197-209. doi: 10.3201/eid0811.020403.
Background: PubMed 8807080Garbe TR, Hibler NS, Deretic V. Isoniazid induces expression of the antigen 85 complex in Mycobacterium tuberculosis. Antimicrob Agents Chemother. 1996 Jul;40(7):1754-6. doi: 10.1128/AAC.40.7.1754.
Background: PubMed 12196086Garcia de Viedma D, Marin M, Hernangomez S, Diaz M, Ruiz Serrano MJ, Alcala L, Bouza E. Tuberculosis recurrences: reinfection plays a role in a population whose clinical/epidemiological characteristics do not favor reinfection. Arch Intern Med. 2002 Sep 9;162(16):1873-9. doi: 10.1001/archinte.162.16.1873.
Background: PubMed 6990260Glassroth J, Robins AG, Snider DE Jr. Tuberculosis in the 1980s. N Engl J Med. 1980 Jun 26;302(26):1441-50. doi: 10.1056/NEJM198006263022603. No abstract available.
Background: PubMed 9114400Jou NT, Yoshimori RB, Mason GR, Louie JS, Liebling MR. Single-tube, nested, reverse transcriptase PCR for detection of viable Mycobacterium tuberculosis. J Clin Microbiol. 1997 May;35(5):1161-5. doi: 10.1128/jcm.35.5.1161-1165.1997.

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RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
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Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
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RecruitingPhase 1/2
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Active, not recruitingPhase 3
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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.

Jann-Yuan Wang, MD principal investigator

National Taiwan University Hospital

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 Tuberculosis, run by National Taiwan University Hospital at 1 site in Taiwan.

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 0 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 9 Dec 2014. 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 Taiwan. 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.

What does the primary outcome measure?

relapse due to reinfection (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00173433, which also lists 20 linked publications.

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 9 Dec 2014.