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

NCT00004444 | Completed

• 2 other identifiers: 199/13445UIC-FDR001167
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis, Pulmonary

Keywords

bacterial infection; immunologic disorders and infectious disorders; mycobacterium infection; mycobacterium tuberculosis infection; rare disease

Interventions

paromomycin DRUG

streptomycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead
• University of Illinois at Chicago: collaborator

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Bacterial Infections; Immune System Diseases; Communicable Diseases; Mycobacterium Infections; Tuberculosis; Rare Diseases

Interventions

Paromomycin; Streptomycin

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Thomas Paul Kanyok

  University of Illinois at Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: November 1, 1994
• Study Completion: January 1, 2001
• Last Updated: March 25, 2015

Record last verified: 2001-02