CLINICAL TRIALS PROFILE FOR PENICILLIN V

505(b)(2) Clinical Trials for Penicillin V

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT05069974 ↗	Alternative Antibiotics for Syphilis	Recruiting	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 3	2021-10-01	The Trep-AB clinical trial will test the efficacy of an investigational neuropenetrative drug, Linezolid (LZD), compared to standard treatment, Benzathine penicillin G (BPG), for early syphilis in humans. The overarching idea of the work proposed herein is to investigate the use of LZD to treat syphilis, conducting a randomized controlled clinical trial to evaluate this new indication of a known antibacterial agent. It is estimated to include 360 participants.

All Clinical Trials for Penicillin V

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000585 ↗	Penicillin Prophylaxis in Sickle Cell Disease (PROPS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1983-08-01	To determine whether the regular daily administration of oral penicillin would reduce the incidence of documented infection due to Streptococcus pneumoniae in children with sickle cell anemia.
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	Hoffmann-La Roche	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.

Clinical Trial Conditions for Penicillin V

Condition Name

Condition Name for Penicillin V
Intervention	Trials
Syphilis	10
Penicillin Allergy	10
Helicobacter Pylori Infection	8

Condition MeSH

Condition MeSH for Penicillin V
Intervention	Trials
Infections	33
Infection	25
Communicable Diseases	24

Clinical Trial Locations for Penicillin V

Trials by Country

Trials by Country for Penicillin V
Location	Trials
United States	197
Canada	20
China	18
Australia	18
Kenya	11

Trials by US State

Trials by US State for Penicillin V
Location	Trials
California	14
Ohio	12
New York	11
Texas	9
North Carolina	9

Clinical Trial Progress for Penicillin V

Clinical Trial Phase

Clinical Trial Phase for Penicillin V
Clinical Trial Phase	Trials
Phase 4	60
Phase 3	38
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Penicillin V
Clinical Trial Phase	Trials
Completed	88
Not yet recruiting	27
Unknown status	26

Clinical Trial Sponsors for Penicillin V

Sponsor Name

Sponsor Name for Penicillin V
Sponsor	Trials
World Health Organization	7
University of Oxford	5
Shandong University	4

Sponsor Type

Sponsor Type for Penicillin V
Sponsor	Trials
Other	351
Industry	25
NIH	9