Older Studies

A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in combination with Other Antiretroviral Agents in People Living with HIV

Sponsor
Gilead Sciences
Study No.
GS-US-200-4334
Key Staff

ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Adult Subjects with Recurrent Clostridioides difficile Infection (RCDI)

Sponsor
Seres Therapeutics
Study No.
SERES-013
Key Staff
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A Phase 3, Multi-Center, Randomized, Open-Label, Assessor-Blind Study to Evaluate the Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection 

Sponsor
Leonard-Meron BioSciences
Study No.
MDA 2013-0039
Key Staff

A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy with Monoclonal Antibodies in Participants with Mild to Moderate COVID-19 Illness (BLAZE-4)

Sponsor
Lilly and Company
Study No.
J2X-MC-PYAH
Key Staff

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis.

Sponsor
ContraFect
Study No.
CF 301-105
Key Staff
Principal Investigator: Paul Cook, M.D.
Team Members: Grace Wilkins, FNP-BC

A Phase 2b, Multicenter, Randomized Open-Label, Assessor-Blinded superiority Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patient with Complicated S. aureus Bacteremia.

Sponsor
Duke with DMID/NIH
Study No.
20-0002
Key Staff
Principal Investigator: Paul Cook, M.D.
Team Members: Jennifer Emberger, M.D.

A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment of Clostridium difficile infection.

Sponsor
Ri-Codify
Study No.
SMT19969/C004
Key Staff
Principal Investigator: Paul Cook, M.D.

GS-US-536-5816 – A Phase 1b Randomized, Blinded, Proof-of-concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination with Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults with HIV-1 Infection.

Sponsor
Gilead Sciences
Study No.
GS-US-536-5816
Key Staff
Principal Investigator: Paul Cook, M.D.
Team Members: Grace Wilkins, FNP-BC

A Phase 3b, Randomized, Multicenter, Active controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alafenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed.

Sponsor
GSK
Study No.
213500
Key Staff
Principal Investigator: Paul Cook, M.D.
Team Members: Alexandra Stang, M.D., Michael Robinson-Thomas, M.D., Grace Wilkins, FNP-C