Clinical trials: Infection Resistant to Multiple Drugs
- Condition Infection Resistant to Multiple Drugs
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multi-drug Resistant Tuberculosis
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
- Trial name
- NCT03470233
- Where
- 2 sites in South Korea
- Volunteers
- 149 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.