drugset / Trial / NCT04504851
Rosuvastatin Evaluation as a Tuberculosis Treatment Adjunct
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial aims to determine whether the addition of rosuvastatin to standard TB therapy in pulmonary tuberculosis results in accelerated of sputum culture conversion. The trial will also investigate potential new biomarkers of sterilising activity and immune-modulatory activity.
Timeline
- Start
- 2020-08-12
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
Publications
- Cross GB, Sari IP, Burkill SM, Yap CW, Nguyen H, Quyet D, Dalay VB, Gutierrez E, Balanag VM, Castillo RJ, Chang CC, Kelleher AD, O'Doherty J, Paton NI. PET-CT outcomes from a randomised controlled trial of rosuvastatin as an adjunct to standard tuberculosis treatment. Nat Commun. 2024 Dec 2;15(1):10475. doi: 10.1038/s41467-024-54419-3.
- Cross GB, Sari IP, Kityo C, Lu Q, Pokharkar Y, Moorakonda RB, Thi HN, Do Q, Dalay VB, Gutierrez E, Balanag VM, Castillo RJ, Mugerwa H, Fanusi F, Kwan P, Chew KL, Paton NI; ROSETTA trial team. Rosuvastatin adjunctive therapy for rifampicin-susceptible pulmonary tuberculosis: a phase 2b, randomised, open-label, multicentre trial. Lancet Infect Dis. 2023 Jul;23(7):847-855. doi: 10.1016/S1473-3099(23)00067-1. Epub 2023 Mar 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rosuvastatin | Small molecule | 10 mg | — |
| Background | Ethambutol | Small molecule | 15 mg/kg | — |
| Background | Isoniazid | Small molecule | 5 mg/kg | — |
| Background | Pyrazinamide | Small molecule | 25 mg/kg | — |
| Background | Rifampin | Small molecule | 10 mg/kg | — |