A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

October 3, 2022

Primary Completion Date

April 10, 2025

Study Completion Date

April 10, 2025

Conditions
Bacterial Disease CarrierCystic Fibrosis
Interventions
OTHER

Placebo

0.9 percent sodium chloride

BIOLOGICAL

WRAIR-PAM-CF1

Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.

Trial Locations (17)

11050

Northwell Health, New Hyde Park

21205

Johns Hopkins University, Baltimore

22612

University of South Florida/Tampa General Hospital, Tampa

22908

University of Virginia, Charlottesville

27710

Duke University Medical Center, Durham

30324

Emory University - Adult Cystic Fibrosis Program, Atlanta

44106

Case Western Reserve University, Cleveland

48109

Michigan Medicine, Ann Arbor

75390

University of Texas Southwestern Medical Center, Dallas

90095

University of California Los Angeles Medical Center - Westwood Clinic, Los Angeles

92037

University of California, San Diego, La Jolla

94305

Stanford University, Stanford

95816

University of California Davis Health, Sacramento

85724-0001

The University of Arizona - Banner University Medical Center Tucson Campus - Tucson, Tucson

06473

Yale North Haven Medical Center- Winchester Center for Lung Disease, North Haven

55455-0341

University of Minnesota Medical Center, Minneapolis

77030-3411

Baylor College of Medicine, Houston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH