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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis, Pulmonary
• Intervention / Treatment: Drug: streptomycin; Drug: paromomycin

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.

• Study Type: Interventional
• Enrollment: 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized

Collaborators and Investigators

• Sponsor: FDA Office of Orphan Products Development
• Collaborators: University of Illinois at Chicago
• Investigators: Study Chair: Thomas Paul Kanyok, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start: November 1, 1994
• Study Completion: January 1, 2001

Study Registration Dates

• First Submitted: October 18, 1999
• First Submitted That Met QC Criteria: October 18, 1999
• First Posted (Estimate): October 19, 1999

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: February 1, 2001

More Information

Terms related to this study

• Keywords: rare disease; bacterial infection; immunologic disorders and infectious disorders; mycobacterium infection; mycobacterium tuberculosis infection
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Paromomycin; Streptomycin
• Other Study ID Numbers: 199/13445; UIC-FDR001167