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NCT00000796 · ClinicalTrials.gov registry record · NA

A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.

A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
NA
Development phase
525
Enrollment target

NCT00000796 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 525 participants.

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The verdict

NCT00000796, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
525 participants
Enrollment target

Study Summary

To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.

Interventions

  • DRUG Cycloserine
  • DRUG Ethionamide
  • DRUG Capreomycin sulfate
  • DRUG Aminosalicylic acid
  • DRUG Streptomycin sulfate

Trial Details

FieldValue
Enrollment Target 525 participants
Est. Completion 1998-10
Phase NA

What the Registry Record Tells You About NCT00000796

The ClinicalTrials.gov registry entry for NCT00000796 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 525 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Cycloserine is the first listed.

NCT00000796 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000796 about?

NCT00000796 is a clinical study titled "A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.". To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-contai...

What is the current status of trial NCT00000796?

This trial is currently completed. It is a NA study. The enrollment target is 525 participants. Estimated completion is 1998-10.

What interventions are being tested in trial NCT00000796?

The interventions under investigation include: Cycloserine (DRUG), Ethionamide (DRUG), Capreomycin sulfate (DRUG), Aminosalicylic acid (DRUG), Streptomycin sulfate (DRUG).

Who is sponsoring clinical trial NCT00000796?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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