Optimization of the TB Treatment Regimen Cascade

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02153528
• Date of registration: 26/05/2014
• Prospective Registration: Yes
• Primary sponsor: Damien Foundation
• Public title: Optimization of the TB Treatment Regimen Cascade OneRIF
• Scientific title: Optimization of the TB Treatment Regimen Cascade
• Date of first enrolment: November 2014
• Target sample size: 701
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02153528
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Bangladesh

Contacts

• Name: Aung Kya Jai Maug, MD
• Affiliation: Damien Foundation Bangladesh

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with smear-positive pulmonary TB

- 15 years or older

- Able and willing to provide written informed consent

Exclusion Criteria:

- contacts of MDR-TB patients and other MDR-TB suspects diagnosed with resistance on
rapid DST for rifampicin performed prior to start of treatment according to NTP
guidelines

- smear-negative pulmonary and extra-pulmonary TB cases

- patients in need of hospitalization because of very bad general condition or
complications

- patients with clinically active liver disease, for the study defined as jaundice
confirmed by a local Medical Officer (Government)

- any known HIV-positive patient (although none are expected)

- any patient with known hepatitis B or C infection

- pregnant women; in addition, patients in the intervention arm who become pregnant
during treatment will be switched to the control arm



Age minimum: 15 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis, Pulmonary

Intervention(s)

Drug: Standard TB treatment

Drug: double rimfampicin

Primary Outcome(s)

Tuberculose Treatment Outcome [Time Frame: 12 months after end of treatment]

Number of Participants Who Develop Liver Toxicity [Time Frame: until month eight]

Secondary Outcome(s)

High-level Rifampicin Resistant TB Adverse Treatment Outcomes [Time Frame: 12 months after end of TB treatment]

Area Under the Curve of Auramine Resp. FDA at 2 Weeks to Predict Adverse Treatment Outcome at 1 Year After Treatment Completion [Time Frame: Auramine/FDA at 2 weeks and adverse treatment outcome 1 year after treatment completion]

Proportion of Acquired Rifampicin Resistance Among Failures and Relapses [Time Frame: 12 months after end of TB treatment]

the Negative Predictive Value of Conversion at 2 Weeks for Relapse. [Time Frame: at 2 weeks of treatment]

Weight Gain [Time Frame: until end of treatment (month eight)]

Fever Resolution [Time Frame: after 2 weeks of treatment]

Number of Initial Resistant TB Cases Who Switched to MDR-TB Treatment or Were Cured [Time Frame: at two weeks of treatment]

Secondary ID(s)

OneRIF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institute of Tropical Medicine, Belgium

National TB control Programme Bangladesh

Results

• Results available: Yes
• Date Posted: 13/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02153528