A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of Nebulized PC945 When Added to Systemic Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
Who is this study for? Patients with refractory invasive pulmonary aspergillosis
What treatments are being studied? PC945
Status: Recruiting
Location: See all (98) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant has proven or probable IPA according to the modified 2019 European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010 International Society for Heart and Lung Transplantation (ISHLT) consensus statements for the definitions of infections in cardiothoracic transplant recipients.
• Participant's IPA has failed to respond to adequate antifungal therapy.
Locations
United States
California
Clinical Research Site
WITHDRAWN
Duarte
Clinical Research Site
RECRUITING
La Jolla
Clinical R Site
RECRUITING
Los Angeles
Clinical Research Site
RECRUITING
Los Angeles
Clinical Research Site
RECRUITING
Sacramento
Florida
Clinical Research Site
RECRUITING
Jacksonville
Indiana
Clinical Research Site
WITHDRAWN
Indianapolis
Kentucky
Clinical Research Site
WITHDRAWN
Lexington
Massachusetts
Clinical Research Site
WITHDRAWN
Boston
Maryland
Clinical Research Site
RECRUITING
Baltimore
Michigan
Clinical Research Site
RECRUITING
Ann Arbor
Minnesota
Clinical Research Site
RECRUITING
Minneapolis
Missouri
Clinical Research Site
RECRUITING
St Louis
New York
Clinical Research Site
RECRUITING
The Bronx
Pennsylvania
Clinical Research Site
ACTIVE_NOT_RECRUITING
Philadelphia
Clinical Research Site
RECRUITING
Pittsburgh
Tennessee
Clinical Research Site
WITHDRAWN
Nashville
Texas
Clinical Research Site 1
RECRUITING
Houston
Clinical Research Site 2
RECRUITING
Houston
Wisconsin
Clinical Research Site
RECRUITING
Madison
Other Locations
Argentina
Clinical Research Site
RECRUITING
Caba
Clinical Research Site
RECRUITING
Caba
Clinical Research Site
RECRUITING
La Plata
Clinical Research Site
RECRUITING
Mendoza
Clinical Research Site
RECRUITING
Rosario
Australia
Clinical Research Site
RECRUITING
Melbourne
Clinical Research Site
RECRUITING
Parkville
Austria
Clinical Research Site
RECRUITING
Graz
Clinical Research Site
RECRUITING
Vienna
Belgium
Clinical Research Site
RECRUITING
Brussels
Clinical Research Site
RECRUITING
Brussels
Clinical Research Site
RECRUITING
Leuven
Brazil
Clinical Research Site
WITHDRAWN
Chapecó
Clinical Research Site
RECRUITING
Curitiba
Clinical Research Site
RECRUITING
Curitiba
Clinical Research Site
RECRUITING
Jaú
Clinical Research Site
RECRUITING
Passo Fundo
Clinical Research Site
RECRUITING
Porto Alegre
Clinical Research Site
RECRUITING
Santa Maria
Clinical Research Site
RECRUITING
Santos
Canada
Clinical Research Site
RECRUITING
Hamilton
Clinical Research Site
RECRUITING
Toronto
Clinical Research Site
RECRUITING
Toronto
Chile
Clinical Research Site
WITHDRAWN
Santiago
Clinical Research Site
RECRUITING
Valparaíso
Colombia
Clinical Research Site
RECRUITING
Medellín
Clinical Research Site
RECRUITING
Montería
Clinical Research Site
RECRUITING
Santiago De Cali
France
Clinical Research Site
RECRUITING
Paris
Clinical Research Site
WITHDRAWN
Pessac
Clinical Research Site
RECRUITING
Strasbourg
Germany
Clinical Research Site
WITHDRAWN
Cologne
Clinical Research Site
RECRUITING
Frankfurt Am Main
Clinical Research Site
RECRUITING
Würzburg
Greece
Clinical Research Site
RECRUITING
Athens
Clinical Research Site
RECRUITING
Thessaloniki
India
Clinical Research Site
RECRUITING
Bengaluru
Clinical Research Site
RECRUITING
Hyderabad
Clinical Research Site
WITHDRAWN
Hyderabad
Clinical Research Site
RECRUITING
New Delhi
Clinical Research Site 1
RECRUITING
Pune
Clinical Research Site 2
RECRUITING
Pune
Israel
Clinical Research Site
RECRUITING
Haifa
Clinical Research Site
RECRUITING
Ramat Gan
Italy
Clinical Research Site
RECRUITING
Brescia
Clinical Research Site
WITHDRAWN
Milan
Clinical Research Site
RECRUITING
Monza
Clinical Research Site
RECRUITING
Naples
Clinical Research Site
RECRUITING
Rome
Clinical Research Site
RECRUITING
Siena
Republic of Korea
Clinical Research Site
RECRUITING
Daejeon
Clinical Research Site
RECRUITING
Incheon
Clinical Research Site
RECRUITING
Seoul
Clinical Research Site
RECRUITING
Seoul
Clinical Research Site
RECRUITING
Seoul
Clinical Research Site
RECRUITING
Seoul
Clinical Research Site
WITHDRAWN
Suwon
Spain
Clinical Research Site
RECRUITING
Barcelona
Clinical Research Site
RECRUITING
Barcelona
Clinical Research Site
RECRUITING
Córdoba
Clinical Research Site
RECRUITING
Granada
Clinical Research Site
RECRUITING
Majadahonda
Clinical Research Site
WITHDRAWN
Santander
Clinical Research Site
RECRUITING
Valencia
Taiwan
Clinical Research Site
RECRUITING
Kaohsiung City
Clinical Research Site
RECRUITING
New Taipei City
Clinical Research Site
RECRUITING
New Taipei City
Clinical Research Site
WITHDRAWN
Tainan City
Clinical Research Site
RECRUITING
Tapei City
Thailand
Clinical Research Site
RECRUITING
Bangkok
Clinical Research Site
RECRUITING
Bangkok
Clinical Research Site
RECRUITING
Khlong Luang
Clinical Research Site
RECRUITING
Khon Kaen
United Kingdom
Clinical Research Site
RECRUITING
Harefield
Clinical Research Site
RECRUITING
London
Clinical Research Site
RECRUITING
London
Clinical Research Site
RECRUITING
London
Clinical Research Site
RECRUITING
Manchester
Contact Information
Primary
Chief Medical Officer
admin@pulmocide.com
+44 (0)203 763 9484
Backup
Senior Medical Director of Clinical Development
admin@pulmocide.com
is +44 (0) 203 763 9484
Time Frame
Start Date: 2022-06-14
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 123
Treatments
Experimental: PC945
PC945 dose, administered via nebulizer, twice daily
Placebo_comparator: Placebo
PC945-placebo administered via nebulizer, twice daily
Related Therapeutic Areas
Sponsors
Leads: Pulmocide Ltd