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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR PENICILLIN-2

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Clinical Trials for Penicillin-2

Trial ID Title Status Sponsor Phase Summary
NCT00000585 Penicillin Prophylaxis in Sickle Cell Disease (PROPS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 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 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 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.
NCT00001359 Preventive Measures for Childhood-Onset Obsessive-Compulsive Disorder and Tic Disorders (PANDAS Subgroup) Completed National Institute of Mental Health (NIMH) Phase 2 A subgroup of patients with childhood-onset obsessive-compulsive disorder (OCD) and/or tic disorders has been identified who share a common clinical course characterized by dramatic onset and symptom exacerbations following group A beta-hemolytic streptococcal (GABHS) infections. This subgroup is designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections). There are five clinical characteristics that define the PANDAS subgroup: presence of OCD and/or tic disorder; prepubertal symptom onset; sudden onset or abrupt exacerbations (relapsing-remitting course); association with neurological abnormalities (presence of adventitious movements or motoric hyperactivity during exacerbations); and temporal association between symptom exacerbations and GABHS infections. In this subgroup, periodic exacerbations appear to be triggered by GABHS infections in a manner similar to that of Sydenham's chorea, the neurological variant of rheumatic fever. Rheumatic fever is a disorder with a presumed post-streptococcal autoimmune etiology. The streptococcal pathogenesis of rheumatic fever is supported by studies that have demonstrated the effectiveness of penicillin prophylaxis in preventing recurrences of this illness. A trial of penicillin prophylaxis in the PANDAS subgroup demonstrated that penicillin was not superior to placebo as prophylaxis against GABHS infections in these children, but this outcome was felt to be secondary to non-compliance with treatment, and there was no decrease in the number of neuropsychiatric symptom exacerbations in this group. In a study comparing azithromycin and penicillin, both drugs were completely effective in preventing streptococcal infections - there were no documented titer elevations during the year-long study period for children taking either penicillin or azithromycin. Comparable reductions in the severity of tics and obsessive-compulsive symptoms were also observed. Thus, penicillin was not performing as an "active placebo" as originally postulated, but rather provided effective prophylaxis against Group A beta-hemolytic streptococcal. Both azithromycin and penicillin appear to be effective in eliminating GABHS infections, and reducing neuropsychiatric symptom severity; thus, between-group differences are negligible. Since increasing the "n" to demonstrate superiority of one prophylactic agent over another would be impractical, we have amended the study design to address two issues: 1. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo in prolonging periods of remission among children in the PANDAS subgroup. 2. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo in improving overall symptom severity for obsessive-compulsive symptoms and tics among children in the PANDAS subgroup. Because penicillin has a narrower therapeutic index and is less expensive than azithromycin, it is the preferable prophylactic agent. Further, penicillin (250 mg orally twice a day) has a long history of providing safe and effective prophylaxis for rheumatic fever and is the first line oral therapy recommended by the American Heart Association. Thus, penicillin has been chosen as the prophylactic antibiotic in the present study. Blister packs are used to increase compliance and to allow for easier documentation of missed doses.
NCT00002682 Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach Completed M.D. Anderson Cancer Center Phase 2 RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Penicillin-2

Condition Name

Condition Name for Penicillin-2
Intervention Trials
Syphilis 7
Pharyngitis 6
Pneumonia 6
Sepsis 6
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Condition MeSH

Condition MeSH for Penicillin-2
Intervention Trials
Infection 18
Communicable Diseases 13
Pneumonia 11
Syphilis 8
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Clinical Trial Locations for Penicillin-2

Trials by Country

Trials by Country for Penicillin-2
Location Trials
United States 167
China 13
Canada 10
Israel 9
Kenya 9
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Trials by US State

Trials by US State for Penicillin-2
Location Trials
California 11
Ohio 10
New York 9
Florida 8
Maryland 7
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Clinical Trial Progress for Penicillin-2

Clinical Trial Phase

Clinical Trial Phase for Penicillin-2
Clinical Trial Phase Trials
Phase 4 37
Phase 3 31
Phase 2 14
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Clinical Trial Status

Clinical Trial Status for Penicillin-2
Clinical Trial Phase Trials
Completed 57
Recruiting 27
Not yet recruiting 17
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Clinical Trial Sponsors for Penicillin-2

Sponsor Name

Sponsor Name for Penicillin-2
Sponsor Trials
World Health Organization 7
University of Oxford 4
National Institute of Allergy and Infectious Diseases (NIAID) 4
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Sponsor Type

Sponsor Type for Penicillin-2
Sponsor Trials
Other 210
Industry 21
NIH 9
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Serving hundreds of leading biopharmaceutical companies globally:

Teva
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Julphar
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Dow
Chubb
Cantor Fitzgerald
Medtronic
Cerilliant

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