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

This study has been completed.
Sponsor:
Collaborator:
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: November 3, 2015
Last verified: November 2015
Results First Received: September 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Tuberculosis
Interventions: Other: Directly Observed Therapy (DOTS) plus
Other: Directly Observed Therapy (DOTS)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All consecutive patients suffering from tuberculosis (TB) of aged 18 years or older with past history of TB treatment of at least 1 month within 5 years and diagnosed with a new episode of sputum smear-positive pulmonary TB requiring treatment were recruited after informed consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Altogether 391 patients were assessed and after excluding those who did not meet inclusion criteria or refused to participate in the study, 225 patients were successfully randomized into DOTS (n=114) and DOTS plus (n=111).

Reporting Groups
  Description
DOTS Strategy 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. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
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.

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


Participant Flow:   Overall Study
    DOTS Strategy   DOTS Plus
STARTED   114   111 
COMPLETED   114   111 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DOTS Strategy 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.
DOTS Plus 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.
Total Total of all reporting groups

Baseline Measures
   DOTS Strategy   DOTS Plus   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   111   225 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.25  (14.5)   48.83  (17.07)   48.05  (15.04) 
Gender 
[Units: Participants]
     
Female   28   27   55 
Male   86   84   170 
X ray lesions severity [1] 
[Units: Participants]
     
Mild   34   18   52 
Moderate   45   47   92 
Severe   35   46   81 
[1]

Severity of chest x-ray (CXR) lesions is graded as follows:

Mild: total area of involvement involving less than the size of right upper lobe; Moderate: total area of involvement was less than the size of right lung field but equal or bigger than right upper lobe; Severe: total area of involvement was bigger than right lung field.

X ray showing cavitation 
[Units: Participants]
     
Positive   54   59   113 
Negative   60   52   112 
Sputum tuberculosis culture 
[Units: Participants]
     
not available   23   21   44 
Culture grew Mycobacterium tuberculosis complex   79   77   156 
Culture grew non-tuberculosis mycobacterium   12   13   25 


  Outcome Measures

1.  Primary:   Number of Participants Suffering From Treatment Failure/ Relapse (Unfavourable Outcome) Among Rifampicin Resistant Group.   [ Time Frame: 18-month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof David SC Hui
Organization: Chinese University of Hong Kong
phone: 2632 3134
e-mail: dschui@cuhk.edu.hk



Responsible Party: Prof David Shu Cheong Hui, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01618422     History of Changes
Other Study ID Numbers: CRE-2008.286-T
Study First Received: June 11, 2012
Results First Received: September 1, 2015
Last Updated: November 3, 2015
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee