drugset / Trial / NCT05896930
Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis
RandomizedParallel-groupOpen-labelOther
Summary
The goal of this single-center, open-labelled, clinical trial in two groups aims to proof that a specific group of antibiotics (carbapenems) can be used to treat pulmonary tuberculosis if it is combined with another antibiotic (amoxicillin/clavulanate). A total of 113 male or female participants (8 groups and 9 treatment regimens as group 8 was split into 2 groups of 4 participants receiving Rifafour e-275), aged between 18 and 65 years (inclusive), with newly diagnosed, smear-positive, pulmonary TB.
Timeline
- Start
- 2017-11-09
- Primary completion
- 2021-01-04
- Completion
- 2021-01-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Subject | Clavulanate | Unknown | 62.5 mg | Oral |
| Subject | Ertapenem | Small molecule | 1 g | Intramuscular |
| Subject | Meropenem | Small molecule | 3 g | Intravenous |
| Subject | Meropenem | Small molecule | 4 g | Intravenous |
| Subject | Meropenem | Small molecule | 6 g | Intravenous |
| Comparator | Rifafour e-275 | Unknown | — | Oral |
| Subject | Rifampin | Small molecule | 35 mg/kg | Oral |