Autopsy report · NCT02013141

Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)

“FDA waived the pediatric study requirement for this application”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year before it started.
• Ran for about 6 years 3 months before it stopped.
• 22 participants enrolled.
• Results were posted on the registry 3 years 3 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

Cumberland Pharmaceuticals

Sponsor type

Industry

Conditions

Gram-Positive Bacterial Infections

Interventions

Telavancin

Participants

22

Sites

7

Countries

United States

Trials that died the same way

• Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)
  “The study was stopped early only due to a business decision to pursue development of a pediatric dedicated device. This decision was not based on any efficacy or safety concerns."” (67% match in meaning)
• Iontophoresis in Psoriasis
  “FDA did not provide approval of the use of the drug for the study” (65% match in meaning)
• Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)
  “Further data are no longer required to support an application for use in pediatric patients. The decision to terminate was not based on any new safety findings” (65% match in meaning)
• Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
  “FDA request as study could not serve as the confirmatory trial.” (64% match in meaning)
• A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
  “study intervention was approved by the FDA” (60% 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.