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Virus Therapy

IV Bacteriophage Therapy for Cystic Fibrosis

Phase 1 & 2

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult (>/= 18 years) at the time of screening

Confirmed CF diagnosis based on a compatible clinical syndrome confirmed by either an abnormal sweat chloride testing or CFTR gene variations* (actual test results not necessary)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 30 ± 7

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a single dose of an IV bacteriophage therapy for treating Pseudomonas aeruginosa in people with Cystic Fibrosis.

Who is the study for?

Adults over 18 with Cystic Fibrosis who have had a Pseudomonas aeruginosa infection in the last year, can produce sputum for testing, and are clinically stable. They must not be on new antibiotics or enrolled in other trials within the past month, weigh at least 30 kg, and have reasonable lung function. Pregnant or breastfeeding women and those with severe liver issues or allergies to trial components cannot participate.Check my eligibility

What is being tested?

The study is examining WRAIR-PAM-CF1 bacteriophage therapy's safety and effectiveness against Pseudomonas aeruginosa in CF patients. Participants will receive one of three doses of this IV treatment or a placebo during different stages to determine the best dose based on safety and microbiological activity.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to the introduction of bacteriophages into the body, such as fever or allergic responses. Specific side effects will be monitored closely given that this is an early-stage trial assessing safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with cystic fibrosis based on symptoms and either a sweat test or genetic test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 30 ± 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 30 ± 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 30 ± 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in log10 P. aeruginosa total colony counts in quantitative sputum cultures

Desirability of Outcome Ranking (DOOR)

Therapeutic procedure

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: Stage 2b Arm 2Active Control1 Intervention

WRAIR-PAM-CF1 concentration determined after post stage 2a analysis, administered intravenously with 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage. N=17

Group II: Stage 1/2a Arm 3Active Control1 Intervention

4x10^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage. Stage 1: N=2 (sentinel subjects); Stage 2a: N=8

Group III: Stage 1/2a Arm 2Active Control1 Intervention

4x10^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage. Stage 1: N=2 (sentinel subjects); Stage 2a: N=8

Group IV: Stage 1/2a Arm 4Active Control1 Intervention

4x10^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage. Stage 1: N=2 (sentinel subjects); Stage 2a: N=8

Group V: Stage 2a Arm 1Placebo Group1 Intervention

25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage. N=8

Group VI: Stage 2b Arm 1Placebo Group1 Intervention

25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage. N=17

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,409 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants aged 25 or older?

"This trial seeks applicants between 18 and 99 years of age. Concurrently, 107 studies are recruiting minors, while 417 trials involve individuals over the age of 65."

Answered by AI

Are there numerous sites across the state executing this investigation?

"Numerous medical centres are currently enrolling participants for this trial, such as UPMC Children's Hospital of Pittsburgh/ University of Pittsburgh in Pittsburg, the University of California Davis Medical Center - Internal Medicine - Infectious disease in Sacramento and the University of South Florida Health-Internal Medicine located in Tampa. There are 34 locations total."

Answered by AI

Is there any possibility of my participation in this research endeavor?

"This clinical trial is searching for 72 people with cystic fibrosis of ages 18 to 99. Notably, applicants should have a medically verified diagnosis, be able to produce at least 2 mL of sputum within 30 minutes following hypertonic saline therapy or another alternative approach and confirm P. aeruginosa isolation from an expectorated sample collected during the screening visit. Moreover, they must provide informed consent and meet all study protocols in order to qualify for participation."

Answered by AI

Are there currently vacancies in this experiment for participants?

"According to the data available on clinicaltrials.gov, this medical study is currently recruiting patients. It was initially posted in October 3rd 2022 and has been amended most recently on November 23rd 2022."

Answered by AI

To what degree is the enrollment for this clinical trial expanding?

"Affirmative. According to clinicaltrials.gov, the listing for this experiment was launched on October 3rd 2022 and last updated on November 23rd of that same year. The trial is actively recruiting 72 people from 34 different sites across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05453578.

All > Cystic Fibrosis