Autopsy report · NCT04186247

Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

“The DSMB concluded that feasibility endpoints were reached in time for Week 4 but no participants receiving standard of care dietary treatment could be randomized based on the at-risk of the microbiome signature.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 8 months before it started.
• Ran for about 2 years 5 months before it stopped.
• 13 participants enrolled.
• Results were posted on the registry 1 year 6 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

University of North Carolina, Chapel Hill

Sponsor type

University, hospital or other

Conditions

Crohn Disease; Pediatric Crohns Disease

Interventions

Azithromycin; Metronidazole; Standard of Care

Participants

13

Sites

5

Countries

Canada, Israel, Netherlands, United States

Trials that died the same way

• Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma
  “Interim analysis-DSMB stated good safety profile but lack of efficacy” (56% 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.