NCT00173433

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

September 12, 2005

Last Update Submit

December 8, 2014

Conditions

Tuberculosis

Keywords

tuberculosisrelapsereinfectionreactivationdormancytuberculin skin test

Outcome Measures

Primary Outcomes (1)

  • relapse due to reinfection

    proportion of patients with exogenous reinfection in those with relapse of TB

    6 years

Study Arms (1)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • culture-proven tuberculosis with recurrence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (20)

  • 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.

    PMID: 11376059BACKGROUND

  • 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.

    PMID: 9989714BACKGROUND

  • 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.

    PMID: 12588714BACKGROUND

  • 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.

    PMID: 11254530BACKGROUND

  • 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.

    PMID: 11673204BACKGROUND

  • 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.

    PMID: 12453355BACKGROUND

  • Davies BH. Infectivity of tuberculosis. Thorax. 1980 Jul;35(7):481-2. doi: 10.1136/thx.35.7.481. No abstract available.

    PMID: 7434308BACKGROUND

  • 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.

    PMID: 12453343BACKGROUND

  • 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.

    PMID: 8807080BACKGROUND

  • 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.

    PMID: 12196086BACKGROUND

  • 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.

    PMID: 6990260BACKGROUND

  • 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.

    PMID: 9114400BACKGROUND

  • 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.

    PMID: 12453357BACKGROUND

  • 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.

    PMID: 10839970BACKGROUND

  • 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.

    PMID: 12453348BACKGROUND

  • Sokolove PE, Mackey D, Wiles J, Lewis RJ. Exposure of emergency department personnel to tuberculosis: PPD testing during an epidemic in the community. Ann Emerg Med. 1994 Sep;24(3):418-21. doi: 10.1016/s0196-0644(94)70178-4.

    PMID: 8080139BACKGROUND

  • Stead WW. Management of health care workers after inadvertent exposure to tuberculosis: a guide for the use of preventive therapy. Ann Intern Med. 1995 Jun 15;122(12):906-12. doi: 10.7326/0003-4819-122-12-199506150-00003.

    PMID: 7755225BACKGROUND

  • Supply P, Mazars E, Lesjean S, Vincent V, Gicquel B, Locht C. Variable human minisatellite-like regions in the Mycobacterium tuberculosis genome. Mol Microbiol. 2000 May;36(3):762-71. doi: 10.1046/j.1365-2958.2000.01905.x.

    PMID: 10844663BACKGROUND

  • van Embden JD, Cave MD, Crawford JT, Dale JW, Eisenach KD, Gicquel B, Hermans P, Martin C, McAdam R, Shinnick TM, et al. Strain identification of Mycobacterium tuberculosis by DNA fingerprinting: recommendations for a standardized methodology. J Clin Microbiol. 1993 Feb;31(2):406-9. doi: 10.1128/jcm.31.2.406-409.1993.

    PMID: 8381814BACKGROUND

  • van Rie A, Warren R, Richardson M, Victor TC, Gie RP, Enarson DA, Beyers N, van Helden PD. Exogenous reinfection as a cause of recurrent tuberculosis after curative treatment. N Engl J Med. 1999 Oct 14;341(16):1174-9. doi: 10.1056/NEJM199910143411602.

    PMID: 10519895BACKGROUND

MeSH Terms

Conditions

TuberculosisRecurrenceReinfection

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jann-Yuan Wang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

TW(1)