Rosuvastatin Evaluation as a Tuberculosis Treatment Adjunct

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

Outcome

Missed primary endpoint

paper hazard ratio 1·30 [0·88-1·91], p=0·19 PMID 36966799 ↗

paper Adjunctive rosuvastatin at 10 mg once per day was safe but did not produce substantive benefits on culture conversion in the overall study population. PMID 36966799 ↗

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	Rifampicin	Small molecule	10 mg/kg	—

Indications