Autopsy report · NCT03219164

Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria

“Study was terminated early by sponsor due to the challenges and risks introduced by Coronavirus disease 2019 (COVID-19) pandemic.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 3 years 10 months before it stopped.
• 149 participants enrolled.
• Results were posted on the registry 8 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Gilead Sciences

Sponsor type

Industry

Conditions

Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization; Cystic Fibrosis

Interventions

AZLI; Placebo

Participants

149

Sites

53

Countries

Austria, Belgium, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Spain, United Kingdom, United States

Trials that died the same way

• A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid
  “The study was prematurely terminated by the Sponsor due to operational challenges stemming from the coronavirus disease 2019 (COVID-19) pandemic, treatment limitations, rarity of the disease, and drug supply considerations.” (93% match in meaning)
• A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors
  “The study was terminated early due to the COVID-19 pandemic and sponsor's funding constraints, based on promising preliminary safety and efficacy data.” (87% match in meaning)
• Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure
  “Sponsor decision to stop study due to COVID-19 pandemic” (83% match in meaning)
• Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation
  “Sponsor has terminated study due to COVID-19 related concerns” (83% match in meaning)
• Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease
  “Study terminated due to COVID-19 pandemic.” (82% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.