Completed

Comparative Study of Intravenous Itraconazole and Amphotericin B in Blastomycosis or Histoplasmosis Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Itraconazole

+ Amphotericin B

Drug
Who is being recruted

Blood-Borne Infections+26

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorJanssen, LP
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002159
Principal SponsorJanssen, LP
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesDermatomycosesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLung DiseasesLung Diseases, FungalMycosesRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSkin DiseasesSkin Diseases, InfectiousSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin and Connective Tissue DiseasesAcquired Immunodeficiency SyndromeAIDS-Related ComplexBlastomycosisHistoplasmosisHIV Infections

Criteria

3 inclusion criteria required to participate
Patients with HIV positive or negative status
Patients with a life expectancy of at least 1 week
Patients with blastomycosis or histoplasmosis
19 exclusion criteria prevent from participating
Patients taking astemizole
Patients taking cisapride
Patients taking oral midazolam
Patients taking phenobarbital
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

UAB Station / Infectious Division

Birmingham, United StatesOpen UAB Station / Infectious Division in Google Maps

Univ of Arkansas for Med Sciences

Little Rock, United States

Division of Infectious Diseases

Atlanta, United States

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, United States
Completed9 Study Centers