NCT04504851

Rosuvastatin Evaluation as a Tuberculosis Treatment Adjunct

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rosuvastatin is an HMG Co-A reductase inhibitor which may be of value as possible adjunctive agents to standard TB therapy. Cell culture assays and animal models demonstrate that statins are bactericidal against Mtb with effects that are additive to that of anti-tuberculous therapy. This is a Phase IIb randomised, controlled, open-label, early bactericidal activity trial. We will recruit patients between the ages of 18 and 75 with newly-diagnosed smear or Xpert positive pulmonary TB, who have had no more than 7 days of TB therapy. Patients will be randomised to take either standard TB therapy or standard TB therapy plus rosuvastatin for the first 8 weeks of their therapy. After the first 8 weeks, patients will continue standard combination TB therapy and remain in trial follow-up until week 24. The trial will collect sputum for culture on a weekly basis for the first 8 weeks of the trial, and less frequently leading up to week 24.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	Rosuvastatin 10mg	10mg of Rosuvastatin in the Intensive Phase of Therapy (8 weeks)
DRUG	Rifampicin	Rifampicin 10mg/kg
DRUG	Isoniazid	Isoniazid 5mg/kg
DRUG	Pyrazinamide	Pyrazinamide 25mg/kg
DRUG	Ethambutol	Ethambutol 15mg/kg

Timeline

• Start date: 2020-08-12
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2020-08-07
• Last updated: 2020-08-07

Locations

6 sites across 4 countries: Philippines, Singapore, Uganda, Vietnam