N/A
N=225
Directly Observed Therapy Short Course-Plus Versus DOTS for Retreatment of Relapsed Pulmonary Tuberculosis in Guangzhou
Pulmonary Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT01618422 ↗Enrolled (actual)
225
Serious AEs
1.8%
Results posted
Oct 2015
Primary outcome: Primary: Number of Participants Suffering From Treatment Failure/ Relapse (Unfavourable Outcome) Among Rifampicin Resistant Group. — 12; 8; 67; 73 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Directly Observed Therapy (DOTS) plus (Other); Directly Observed Therapy (DOTS) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chinese University of Hong Kong
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Suffering From Treatment Failure/ Relapse (Unfavourable Outcome) Among Rifampicin Resistant Group. |
12; 8; 67; 73; 0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01618422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.