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Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis

Primary Purpose

Tuberculosis, Pulmonary

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
paromomycin
streptomycin
Sponsored by
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis, Pulmonary focused on measuring bacterial infection, immunologic disorders and infectious disorders, mycobacterium infection, mycobacterium tuberculosis infection, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Microbiologically proven uncomplicated pulmonary tuberculosis Positive direct sputum smear for acid-fast bacilli OR Presumptive diagnosis based on clinical and radiological findings No known risk factors for multidrug resistant tuberculosis (MDR TB) including: Domicile, shelter, or prison exposure to MDR TB within 6 months Residence in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB Hospitalization, within 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred No clinical evidence of CNS or miliary tuberculosis HIV seronegative --Prior/Concurrent Therapy-- Biologic therapy: At least 12 weeks since immune modulators (including colony-stimulating factors, interferons, or interleukins) Chemotherapy: No concurrent chemotherapy Endocrine therapy: At least 12 weeks since corticosteroids Other: At least 2 years since treatment or prophylaxis for tuberculosis At least 12 weeks since treatment with any drug with activity against tuberculosis, including: All standard drugs used for tuberculosis Clofazimine Rifabutin Quinolones Aminoglycosides At least 12 weeks since pentoxifylline --Patient Characteristics-- Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Renal: Creatinine clearance greater than 60 mL/min Pulmonary: No chronic obstructive pulmonary disease Other: Not pregnant Fertile patients must use effective contraception No history of intolerance or known hypersensitivity to aminoglycosides No known or suspected Mycobacterium avium complex infection No other serious, acute infection No diabetes No major organ dysfunction No malignancy requiring chemotherapy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    University of Illinois at Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004444
    Brief Title
    Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2001 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    University of Illinois at Chicago

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Compare the pharmacokinetics and early bactericidal activity of paromomycin (aminosidine) vs streptomycin for the treatment of uncomplicated pulmonary tuberculosis. II. Compare the tolerability of these two drugs in these patients. III. Establish the relationships between achieved serum concentration, minimal inhibitory concentration, and early bactericidal activity of paromomycin and streptomycin.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of three treatment arms. Patients in arms I and II receive one of two doses of paromomycin intramuscularly once a day for 3 days. Patients in arm III receive streptomycin intramuscularly once a day for 3 days. All patients then begin a course of standard therapy for tuberculosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tuberculosis, Pulmonary
    Keywords
    bacterial infection, immunologic disorders and infectious disorders, mycobacterium infection, mycobacterium tuberculosis infection, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    24 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    paromomycin
    Intervention Type
    Drug
    Intervention Name(s)
    streptomycin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Microbiologically proven uncomplicated pulmonary tuberculosis Positive direct sputum smear for acid-fast bacilli OR Presumptive diagnosis based on clinical and radiological findings No known risk factors for multidrug resistant tuberculosis (MDR TB) including: Domicile, shelter, or prison exposure to MDR TB within 6 months Residence in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB Hospitalization, within 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred No clinical evidence of CNS or miliary tuberculosis HIV seronegative --Prior/Concurrent Therapy-- Biologic therapy: At least 12 weeks since immune modulators (including colony-stimulating factors, interferons, or interleukins) Chemotherapy: No concurrent chemotherapy Endocrine therapy: At least 12 weeks since corticosteroids Other: At least 2 years since treatment or prophylaxis for tuberculosis At least 12 weeks since treatment with any drug with activity against tuberculosis, including: All standard drugs used for tuberculosis Clofazimine Rifabutin Quinolones Aminoglycosides At least 12 weeks since pentoxifylline --Patient Characteristics-- Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Renal: Creatinine clearance greater than 60 mL/min Pulmonary: No chronic obstructive pulmonary disease Other: Not pregnant Fertile patients must use effective contraception No history of intolerance or known hypersensitivity to aminoglycosides No known or suspected Mycobacterium avium complex infection No other serious, acute infection No diabetes No major organ dysfunction No malignancy requiring chemotherapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Paul Kanyok
    Organizational Affiliation
    University of Illinois at Chicago
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis

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