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A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis Clinical research trials and A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis. A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis clinical trial. Test subjects typically receive the most expert healthcare available for their A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis



A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

For Condition: HIV Infections,Histoplasmosis,Blastomycosis
Status: Completed
Sponsor(s): Janssen Pharmaceutica ,
Synopsis: To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
Details: Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV positive or negative status. - Blastomycosis or histoplasmosis. - Life expectancy of at least 1 week. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Liver disease. - Self-limiting fungal disease. - Very severe fungal disease such as meningeal involvement. - Acute respiratory disease. Concurrent Medication: Excluded at any time: - Terfenadine. - Astemizole. - Oral midazolam. - Triazolam. - Cisapride. - Phenytoin. - Phenobarbital. - Rifampin. - Rifabutin. Excluded during oral consolidation: - H2 blockers. - Chronic antacids. - Omeprazole. - Lansoprazole. Patients with the following prior condition are excluded: Hypersensitivity to azole antifungals. Prior Medication: Excluded at any time: More than 3 days of amphotericin B, fluconazole, or ketoconazole. Excluded within 2 weeks prior to study entry: - Phenytoin. - Phenobarbital. - Rifampin. - Rifabutin.
Total Enrollment: 60

Location and Contact Information:

LSU Med Ctr / Div of Pulmonary & Critical Care Med
Shreveport,  Louisiana,  71130
United States
 

Univ of Missouri / Division of Infectious Diseases
Kansas City,  Missouri,  641082792
United States
 

Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis,  Indiana,  46202
United States
 

Division of Infectious Diseases
Atlanta,  Georgia,  30303
United States
 

Ann Arbor Veterans Administration Med Ctr
Ann Arbor,  Michigan,  48105
United States
 

Infectious Diseases Association / Research Med Ctr
Kansas City,  Missouri,  64132
United States
 

Univ of Arkansas for Med Sciences
Little Rock,  Arkansas,  72205
United States
 

Community Hosp
Indianapolis,  Indiana,  46218
United States
 

UAB Station / Infectious Division
Birmingham,  Alabama,  35294
United States
 


Additional Information:
Study ID Numbers:
  254A;  ITR-USA-118
Study Start Date: 
Record last reviewed: December 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002159

Other Blastomycosis Studies:
1. Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis

2. A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

3. Evaluation of the Association of Polymorphisms in the Innate Immune System with the Risk for Blastomycosis dermatitidis Infection in Patients not Infected with HIV and Complications Associated with Blastomycosis dermatitidis Infection

4. Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis

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A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

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