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NCT03162250 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics
A Phase 1 study of Bacteremia, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 16
- Study locations
NCT03162250: Completed Phase 1 study of Bacteremia, sponsored by Genentech.
NCT03162250 is a Phase 1 study of Bacteremia that has completed, run by Genentech. The registered enrollment target is 27 participants, below the 7,574-participant average among 11 other Bacteremia trials with a reported enrollment target (100% lower). The trial reports 16 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03162250, a Phase 1 study of Bacteremia, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 16
- Study locations
Study Summary
This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S when given in addition to anti-staphylococcal SOC antibiotics to participants with methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SOC
- DRUG DSTA4637S
Study Locations (16)
Other
- Chungnam National University Hospital - Daejeon
- Gyeongsang National University Hospital - Gyeongsangnam-do
- Asan Medical Center - Oncology - Seoul
- Korea University Guro Hospital - Seoul
- Hospital del Mar - Barcelona
- Hospital Clinic de Barcelona - Barcelona
- Hospital Universitario Ramon y Cajal - Madrid
- Hospital Universitario Virgen Macarena - Seville
- Hospital Universitario Virgen del Rocio - Seville
Michigan
- Henry Ford Health System - Detroit
- William Beaumont Hospital - Royal Oak
Barcelona
- Hospital Universitario de Bellvitge - L'Hospitalet de Llobregat
- Hospital Mutua de Terrassa - Terrassa
California
- Los Angeles Biomedical Research Institute at Harbor-UCLA - Torrance
North Carolina
- Duke University Medical Center - Durham
Cantabria
- Hospital Universitario Marques de Valdecilla - Santander
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-07-13 |
| Est. Completion | 2020-01-15 |
| Phase | Phase 1 |
What the finished NCT03162250 record still lists
NCT03162250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 7,574-participant average among 11 other Bacteremia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Bacteremia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03162250 lists 16 locations in 6 states (Other, Michigan, Barcelona).
Frequently Asked Questions
What is clinical trial NCT03162250 about?
NCT03162250 is a clinical study titled "Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics". This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S when given in addition to anti-staphylococcal SOC antibiotics to participants with methicillin-resistant staphylo...
What is the current status of trial NCT03162250?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-07-13. Estimated completion is 2020-01-15.
What conditions does trial NCT03162250 study?
This clinical trial studies the following conditions: Bacteremia.
What interventions are being tested in trial NCT03162250?
The interventions under investigation include: Placebo (DRUG), SOC (DRUG), DSTA4637S (DRUG).
Who is sponsoring clinical trial NCT03162250?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03162250 being conducted?
This trial has 16 study locations across California, Michigan, North Carolina, Barcelona, Cantabria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03162250's enrollment target sits among peer trials
27 12th of 11 the lowest of 11 other Bacteremia trials
participants (enrollment target), bucketed by value
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