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Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR PENICILLIN G BENZATHINE


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505(b)(2) Clinical Trials for Penicillin G Benzathine

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 FundaciĆ³n FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la PromociĆ³n 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Penicillin G Benzathine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00031499 ↗ Azithromycin/Bicillin Syphilis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 2000-06-01 The purpose of this study is to determine if azithromycin, a drug approved for treatment of other infections, is as effective for syphilis (a sexually transmitted disease) as the standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55 years of age, with primary, secondary or early latent syphilis, will participate in this research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures will include blood samples, physical exams, and swabs of sores.
NCT01156740 ↗ Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings Completed Cairo University N/A 2001-08-01 The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
NCT01156740 ↗ Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings Completed United States Agency for International Development (USAID) N/A 2001-08-01 The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
NCT01156740 ↗ Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings Completed Universidade Federal do Rio de Janeiro N/A 2001-08-01 The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
NCT01156740 ↗ Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings Completed University Hospital for Infectious Diseases, Croatia N/A 2001-08-01 The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
NCT01156740 ↗ Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings Completed World Health Organization N/A 2001-08-01 The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Penicillin G Benzathine

Condition Name

Condition Name for Penicillin G Benzathine
Intervention Trials
Syphilis 8
Yaws 2
Treponema Infection 1
Neglected Tropical Disease 1
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Condition MeSH

Condition MeSH for Penicillin G Benzathine
Intervention Trials
Syphilis 10
HIV Infections 2
Acquired Immunodeficiency Syndrome 2
Streptococcal Infections 1
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Clinical Trial Locations for Penicillin G Benzathine

Trials by Country

Trials by Country for Penicillin G Benzathine
Location Trials
United States 15
Madagascar 3
China 3
Brazil 3
Papua New Guinea 2
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Trials by US State

Trials by US State for Penicillin G Benzathine
Location Trials
North Carolina 2
Maryland 2
Louisiana 2
Indiana 2
Alabama 2
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Clinical Trial Progress for Penicillin G Benzathine

Clinical Trial Phase

Clinical Trial Phase for Penicillin G Benzathine
Clinical Trial Phase Trials
Phase 4 6
Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Penicillin G Benzathine
Clinical Trial Phase Trials
Completed 7
Unknown status 5
Recruiting 4
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Clinical Trial Sponsors for Penicillin G Benzathine

Sponsor Name

Sponsor Name for Penicillin G Benzathine
Sponsor Trials
World Health Organization 3
Lihir Medical Centre 2
National Institute of Allergy and Infectious Diseases (NIAID) 2
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Sponsor Type

Sponsor Type for Penicillin G Benzathine
Sponsor Trials
Other 42
NIH 2
Industry 1
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