Autopsy report · NCT01110421

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia

“Trial terminated early per business decision”

The sponsor’s own words in the registry.

Life of this trial

• Registered 8 months before it started.
• Ran for about 1 year 3 months before it stopped.
• 7 participants enrolled.
• Results were posted on the registry 2 years 4 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Janssen Research & Development, LLC

Sponsor type

Industry

Conditions

Pneumonia, Bacterial; Community-Acquired Infections; Nosocomial Infection; Pneumonia, Ventilator-Associated

Interventions

Cefepime placebo; Cefepime; Doripenem; Doripenem placebo; Amoxicillin/clavulanate potassium

Participants

7

Sites

25

Countries

Argentina, Brazil, Colombia, Latvia, Lithuania, Mexico, Panama, Poland, Ukraine, United States

Trials that died the same way

• Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
  “Company decision to discontinue trial” (81% match in meaning)
• One Touch® Verio®IQ European Clinical Outcomes Study
  “Business decision to withdraw trial” (78% match in meaning)
• Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors
  “Trial terminated due to business decision, not based on any safety or efficacy concerns.” (78% match in meaning)
• Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7
  “The trial ended earlier than planned due to slow enrolment, which has made it unfeasible to achieve the target sample size within a reasonable timeframe. Consequently, a business decision has been made to discontinue funding for the trial.” (73% match in meaning)
• Pancreatic Enzyme Supplementation for Celiac Disease
  “The trial was terminated prematurely by the sponsor for administrative reasons.” (72% 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.