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KRM-1648 (Rifalazil) - DMID 97-012

An Open Label Multiple Dose Study of the Safety and the Early Bactericidal Activity of KRM-1648 (Rifalazil) in the Treatment of Newly Diagnosed Adults With Smear-Positive Pulmonary Tuberculosis

Information:

DMID Protocol Number: 97-012

Type of Study

Phase I/II Clinical Trial

Design

Randomized, multiple dose, open-label controlled trial

Project Site

Centro Biomedico, Universidade Federal do Espirito, Vitoria, Brazil

Sample Size

60 subjects

Population

Adults, 18 to 65 years of age in 4 treatment groups

  • Group 1: 15 patients: INH (200 \x96 400 mg/d) for 14 days
  • Group 2: 15 patients: INH (200 \x96 400 mg/d) and RMP (300 \x96 600 mg/d) for 14 days
  • Group 3: 15 patients: INH (200 \x96 400 mg/d) for 14 days and KRM 10 mg on Day 1 and Day 8
  • Group 4: 15 patients: INH (200 \x96 400 mg/d) for 14 days and KRM 25 mg on Day 1 and Day 8

After completion of this 14-day study, all groups received daily INH, RMP, PZA, and EMB for 2 months and then 4 months of daily INH and RMP as standard therapy for tuberculosis.

Study Period

1997-1998

Goal of Study:

To assess the safety, pharmacokinetics and early bactericidal activity of KRM-1648 (Rifalazil) as a therapeutic agent in the treatment of pulmonary tuberculosis

Objectives of Study:

  1. Assess the safety to the patient both from underlying disease and from adverse drug experiences.
  2. Determine the evidence of efficacy and appropriate dose.
  3. Determination of pharmacokinetics.
  4. Evaluate the utility of surrogate microbial markers for bacillary load and in vivo antibacterial activity.

The results of this completed study can be found in:

Dietze R, Teixeira L, Canedo Rocha LM, Palaci M, Johnson JL, Wells C, Rose L, Eisenach K, Ellner JJ. Safety and bactericidal activity of rifalazil in patients with pulmonary tuberculosis. Antimicrob Agents Chemother 2001; 45:1972-1976. PMCID: PMC90587.

Wallis RS, Phillips M, Johnson JL, Teixeira L, Canedo Rocha L, Maciel E, Rose L, Wells C, Palaci M, Dietze R, Eisenach K, and Ellner JJ. Inhibition of Isoniazid-Induced Expression of Mycobacterium tuberculosis Antigen 85 in Sputum: Potential Surrogate Marker in Tuberculosis Chemotherapy Trials. Antimicrob Agents Chemother 2001; 45:1302-1304. PMCID: PMC90462.