An Open-label, Non-controlled, Multicentre, Pilot Clinical Trial of Inhaled Molgramostim in Subjects With Antibiotic-resistant Non-tuberculosis Mycobacterial (NTM) Infection
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 19 Dec 2018
At a glance
- Drugs Molgramostim (Primary)
- Indications Bacterial infections; Mycobacterial infections; Mycobacterium avium complex infections; Respiratory tract infections
- Focus Therapeutic Use
- Acronyms OPTIMA
- Sponsors Savara Pharmaceuticals
- 19 Dec 2018 According to a Savara Pharmaceuticals media release, based on the microbiological data and safety profile, which provides the basis to continue treating patients for a longer period of time, the duration of this study is extended from 24 to 48 weeks.This increases the ability to observe a more robust anti-infective effect, including culture conversions. Final results from this study are now expected by the first quarter of 2020.
- 19 Dec 2018 Interim analysis results assessing efficacy (microbiological results, n=14) and safety (n=32) presented in a Savara Pharmaceuticals media release.
- 31 Oct 2018 Status changed from recruiting to active, no longer recruiting, according to a Savara Pharmaceuticals media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History