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ongoing trials trial from www.clinicaltrials.gov

Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis - Phase 1|Phase 2 - Recruiting

  • Year: 2020
  • Date: December 22, 2020
  • Author: Armata Pharmaceuticals, Inc.|Cystic Fibrosis Foundation
Source

https://ClinicalTrials.gov/show/NCT04596319

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment

Participants

Cystic Fibrosis|Pseudomonas Aeruginosa|Pseudomonas|Lung Infection|Lung Infection Pseudomonal - 18 Years and older   (Adult, Older Adult)

Interventions

Biological: AP-PA02|Other: Placebo

Outcome measures

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) of single and multiple doses of AP-PA02 administered by inhalation|Part 2 (MAD) Only: Explore P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation

Related topics

Antibiotic treatment for stenotrophomonas maltophilia in people with cystic fibrosis

Antibiotic treatment of early pseudomonas aeruginosa

Antibiotics for pulmonary exacerbations

Inhaled antibiotics in cystic fibrosis

MRSA eradication in CF

Prophylactic use of oral antistaphylococcal antibiotic

Scheduled antibiotics every 3-4 months / symptom-based treatment

Keywords: AP-PA02; Phage therapy; Anti-bacterial agents; pharmacological_intervention; Bacterial Infections; Infection; Inhalation OR nebulised; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections;