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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)

Must not have

Body weight < 30 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 8 + 3

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My body weight is less than 30 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 8 + 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 8 + 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 8 + 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Desirability of Outcome Ranking (DOOR)

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 / 3Eligibility criteria met