Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Faropenem · 1 trial · 1 indication
The EBA CFU(0-14) as determined by the rate of change in logCFU per ml sputum over the period Day 0 to Day 14 which will be described with at most 3 parameters from a linear, bi-linear or non-linear regression of logCFU on time
| Arm | Type | Description |
|---|---|---|
| Meropenem;amoxycillin/clavulanic acid | EXPERIMENTAL | Meropenem 2g will be administered intravenously 8-hourly; plus amoxycillin/CA 500mg/125mg will be administered orally 8-hourly for 14 days |
| Faropenem; amoxycillin/CA | EXPERIMENTAL | Faropenem 600mg will be administered orally 8-hourly; plus amoxycillin/CA 500mg/125mg will be administered orally 8-hourly for 14 days |
| Rifafour e-275 | ACTIVE_COMPARATOR | Rifafour e-275 will be administered orally once daily for 14 days as per South African National TB Treatment Guidelines |
| Name | Type | Description |
|---|---|---|
| Meropenem | DRUG | To administer 2g daily 8 hourly for 14 days |
| Faropenem | DRUG | To adminster 600mg 8 hourly daily for 14 days |
| Amoxycillin/clavulanic acid | DRUG | To administer 625mg 8 hourly daily for 14 days together with the faropenem and meropenem |
| Rifafour e275 | DRUG | To be taken as per the National TB treatment programme for 14 days |
Inclusion Criteria: 1. Provide written, informed consent prior to all trial-related procedures including HIV testing. 2. Male or female, aged between 18 and 65 years, inclusive. 3. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive. 4. Newly diagnosed, previously untr...