Directly Observed Therapy Short Course-Plus Versus DOTS for Retreatment of Relapsed Pulmonary Tuberculosis in Guangzhou

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Center for Health Protection, HKSAR.
Guangzhou Chest Hospital.
Guangzhou Institute of Respiratory Disease
Information provided by (Responsible Party):
Prof David Shu Cheong Hui, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01618422
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012

June 11, 2012
June 12, 2012
March 2009
February 2013   (final data collection date for primary outcome measure)
combined treatment failure/ relapse (unfavourable outcome) among rifampicin resistant group. [ Time Frame: 18-month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01618422 on ClinicalTrials.gov Archive Site
combined treatment failure/ relapse (unfavourable outcome) among rifampicin resistant group, MDR-TB cases and all retreatment cases; [ Time Frame: 30-month ] [ Designated as safety issue: No ]
Other endpoints: Sputum smear/culture conversion rate at 2m, 3m, 8m, 12m, 18m, and 24m; Drug resistance rates to various drugs in particular rifampicin, and rate of MDR-TB; The predictive factors of unfavourable treatment outcomes (including failure and relapse) will be analysed.
Same as current
Not Provided
Not Provided
 
Directly Observed Therapy Short Course-Plus Versus DOTS for Retreatment of Relapsed Pulmonary Tuberculosis in Guangzhou
A Randomized, Parallel, Controlled Study to Evaluate the Role of Directly Observed Therapy Short Course-Plus (DOTS-Plus) Versus DOTS for Retreatment of Relapsed Pulmonary TB in Guangzhou.

This is a prospective, randomized, parallel, controlled study comparing the efficacy and outcomes in the retreatment of pulmonary Tuberculosis (TB) in Guangzhou in a group using pretreatment susceptibility tests in selection of chemotherapy regimens and that in another group without using pretreatment susceptibility test results. The investigators hypothesize that selecting drug treatment on the basis of known susceptibility tests would lead to improved outcome compared with empiric treatment.

The aims are:1) To evaluate the efficacy and outcomes in the retreatment of pulmonary TB in Guangzhou by the use of pretreatment susceptibility tests in selection of chemotherapy regimens & 2) To study the predictive factors of unfavourable outcomes in the retreatment of pulmonary TB in Guangzhou, where unfavourable outcomes include treatment failures and relapses.

The patients will be randomized into either a) The DOTS strategy consisting of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment; or b) The DOTS-Plus strategy includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs.

The Primary end point is the 18-month combined treatment failure/ relapse (unfavourable outcome) among rifampicin resistant group. Secondary endpoints include the 30-month combined treatment failure/ relapse (unfavourable outcome) among rifampicin resistant group, MDR-TB cases and all retreatment cases; Sputum smear/conversion rate at 2m, 3m, 8m, 12m, 18m, and 24m; Drug resistance rates to various drugs in particular rifampicin, and rate of MDR-TB. The predictive factors of unfavourable treatment outcomes (including failure and relapse) will be analysed.

The management of retreatment cases by DOTS alone is often problematic, especially when there is resistance to rifampicin, and treatment failure / relapse with further resistances might result. With implementation of the "DOTS-plus" strategy, HK has achieved a low MDR-TB prevalence of around 1%. This study will provide important data on the predictors of treatment failure/ relapse of retreatment cases and whether the DOTS-plus strategy can effectively reduce the failure/relapse rate and the prevalence rate of MDR-TB in Guangzhou. The project will provide useful data on the surveillance, epidemiology and public health control of TB with a regional (cross-border) significance.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Tuberculosis
  • Other: Directly Observed Therapy (DOTS) plus
    The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
  • Other: Directly Observed Therapy (DOTS)
    The DOTS strategy (current strategy) consists of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment. The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin (2HRZE/4HR or 2HRZS/4HR). In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used (2HRZES/1HRZE/5HRE).
  • Active Comparator: DOTS strategy
    The DOTS strategy (current strategy) consists of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment. The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin (2HRZE/4HR or 2HRZS/4HR). In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used (2HRZES/1HRZE/5HRE).
    Intervention: Other: Directly Observed Therapy (DOTS)
  • Active Comparator: DOTS plus
    The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
    Intervention: Other: Directly Observed Therapy (DOTS) plus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
February 2014
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

All consecutive smear positive pulmonary TB patients aged at least 18 years, with past history of TB treatment, diagnosed with a new episode of active pulmonary TB requiring treatment will be recruited and randomized into two groups, with Group A with management based essentially on the DOTS strategy, while Group B based essentially on the DOTS-plus strategy.

Exclusion Criteria:

  • Age < 18 yrs;
  • New TB cases (without past history of anti-TB treatment) will be excluded because they have a much lower risk for MDR-TB than the retreatment cases.
Both
18 Years to 90 Years
No
Contact: David S Hui, MD 852-26323128 dschui@cuhk.edu.hk
Contact: Chi-Chiu Leung, MBBS cc_leung@dh.gov.hk
China
 
NCT01618422
CRE-2008.286-T
Yes
Prof David Shu Cheong Hui, Chinese University of Hong Kong
Chinese University of Hong Kong
  • Center for Health Protection, HKSAR.
  • Guangzhou Chest Hospital.
  • Guangzhou Institute of Respiratory Disease
Principal Investigator: David S Hui, MD Chinese University of Hong Kong
Chinese University of Hong Kong
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP