drugset / Trial / NCT02381470

Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers

NCT02381470

Phase 2 Completed 58 enrolled National University Hospital, Singapore
RandomizedParallel-groupSingle-blindTreatment

Summary

This trial aims to determine whether the early bactericidal activity of rifampicin given with faropenem or cefadroxil (each given with amoxicillin/clavulanic acid) is greater than the activity of rifampicin alone in patients with pulmonary TB. The trial will also investigate potential new biomarkers of sterilising activity.

Timeline

Start
2019-02-11
Primary completion
2019-09-28
Completion
2019-10-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 500 mg
Subject Cefadroxil Small molecule 1 g Oral
Subject Faropenem Small molecule 600 mg Oral
Subject clavulanic acid Small molecule 125 mg
Comparator Rifampin Small molecule 10 mg/kg