Multidrug rezistant pulmonary tuberculosis
Conditions
Brief summary
To examine the safety, tolerability, and preliminary efficacy of two adjuvant TB-HDT therapies (one anti-inflammatory and one antimicrobial) in patients with rifampicin-resistant pulmonary tuberculosis. Efficacy endpoints will include measures of lung function recovery and eradication of M tuberculosis infection. Time point of assessment for this primary endpoint: month 6 (nominal months of 4 weeks)
Detailed description
1. FEV1 at month 6 2. Probability of stable culture conversion by month 6 Both co-primary endpoints must be met for a treatment to be considered successful. The CC-11050 and Metformin arms will each be compared to the control arm. Time of assessment of this secondary endpoint: Up to 18 months after study entry.
Interventions
DRUGMetformin Zentiva 500 mg Filmtabletten
Sponsors
The Aurum Institute, Quality Regulatory Clinical Ireland Limited, Quality Regulatory Clinical Ireland Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the safety, tolerability, and preliminary efficacy of two adjuvant TB-HDT therapies (one anti-inflammatory and one antimicrobial) in patients with rifampicin-resistant pulmonary tuberculosis. Efficacy endpoints will include measures of lung function recovery and eradication of M tuberculosis infection. Time point of assessment for this primary endpoint: month 6 (nominal months of 4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. FEV1 at month 6 2. Probability of stable culture conversion by month 6 Both co-primary endpoints must be met for a treatment to be considered successful. The CC-11050 and Metformin arms will each be compared to the control arm. Time of assessment of this secondary endpoint: Up to 18 months after study entry. | — |
Countries
Romania
Outcome results
None listed