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

This study has been completed.

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	University of Illinois
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004444

Purpose

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.

Condition	Intervention
Tuberculosis, Pulmonary	Drug: paromomycin Drug: streptomycin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Mycobacterial Infections Tuberculosis

Drug Information available for: Streptomycin Paromomycin sulfate Streptomycin sulfate Paromomycin

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	24
Study Start Date:	November 1994
Estimated Study Completion Date:	January 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004444

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of Illinois

Investigators

Study Chair:

Thomas Paul Kanyok

University of Illinois

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004444 History of Changes
Other Study ID Numbers:	199/13445, UIC-FDR001167
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

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

Additional relevant MeSH terms:

Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Paromomycin
Streptomycin

Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012