Trial reportAntimicrobial agents and chemotherapy2001
Safety and bactericidal activity of rifalazil in patients with pulmonary tuberculosis.
Trial report in Antimicrobial agents and chemotherapy, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.
- Pooled it
- Therapeutic efficacy of rifalazil (KRM-1648) in a M. ulcerans-induced Buruli ulcer mouse model.PloS one · 2022Article
- The future for early-stage tuberculosis drug discovery.Future microbiology · 2015Review
- Comparative study of the effects of antituberculosis drugs and antiretroviral drugs on cytochrome P450 3A4 and P-glycoprotein.Antimicrobial agents and chemotherapy · 2014Article
- Antibacterial activity of rifamycins for M. smegmatis with comparison of oxidation and binding to tear lipocalin.Biochimica et biophysica acta · 2014Article
- New antituberculous drugs in development.Current HIV/AIDS reports · 2010Review
- Future novel therapeutic agents for Clostridium difficile infection.Expert opinion on investigational drugs · 2010Review
- Sputum Mycobacterium tuberculosis mRNA as a marker of bacteriologic clearance in response to antituberculosis therapy.Journal of clinical microbiology · 2010Article
- Monitoring therapeutic efficacy by real-time detection of Mycobacterium tuberculosis mRNA in sputum.Clinical chemistry · 2009Article
- Assessment of the Efficacy of New Anti-Tuberculosis Drugs.The open infectious diseases journal · 2008Article
- Cavitary disease and quantitative sputum bacillary load in cases of pulmonary tuberculosis.Journal of clinical microbiology · 2007Article
- Efficacy of novel rifamycin derivatives against rifamycin-sensitive and -resistant Staphylococcus aureus isolates in murine models of infection.Antimicrobial agents and chemotherapy · 2006Article
- In vitro activity of novel rifamycins against rifamycin-resistant Staphylococcus aureus.Antimicrobial agents and chemotherapy · 2006Article
- Interaction of rifalazil with oxidant-generating systems of human polymorphonuclear neutrophils.Antimicrobial agents and chemotherapy · 2005Article
- Rifampin-resistant RNA polymerase mutants of Chlamydia trachomatis remain susceptible to the ansamycin rifalazil.Antimicrobial agents and chemotherapy · 2005Article
- Emergence of resistance to rifampin and rifalazil in Chlamydophila pneumoniae and Chlamydia trachomatis.Antimicrobial agents and chemotherapy · 2005Article
- In vitro activities of rifamycin derivatives ABI-1648 (Rifalazil, KRM-1648), ABI-1657, and ABI-1131 against Chlamydia trachomatis and recent clinical isolates of Chlamydia pneumoniae.Antimicrobial agents and chemotherapy · 2003Article
- Intramacrophage passage of Mycobacterium tuberculosis and M. avium complex alters the drug susceptibilities of the organisms as determined by intracellular susceptibility testing using macrophages and type II alveolar epithelial cells.Antimicrobial agents and chemotherapy · 2002Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
Abstract
Rifalazil, also known as KRM-1648 or benzoxazinorifamycin, is a new semisynthetic rifamycin with a long half-life of approximately 60 h. Rifalazil has potent bactericidal activity against Mycobacterium tuberculosis in vitro and in animal models of tuberculosis (TB). Prior studies in healthy volunteers showed that once-weekly doses of 25 to 50 mg of rifalazil were well tolerated. In this randomized, open-label, active-controlled phase II clinical trial, 65 subjects with sputum smear-positive pulmonary TB received one of the following regimens for the first 2 weeks of therapy: 16 subjects received isoniazid (INH) (5 mg/kg of body weight) daily; 16 received INH (5 mg/kg) and rifampin (10 mg/kg) daily; 17 received INH (5 mg/kg) daily plus 10 mg of rifalazil once weekly; and 16 received INH (5 mg/kg) daily and 25 mg of rifalazil once weekly. All subjects were then put on 6 months of standard TB therapy. Pretreatment and day 15 sputum CFU of M. tuberculosis were measured to assess the bactericidal activity of each regimen. The number of drug-related adverse experiences was low and not significantly different among treatment arms. A transient decrease in absolute neutrophil count to less than 2,000 cells/mm(3) was detected in 10 to 20% of patients in the rifalazil- and rifampin-containing treatment arms without clinical consequences. Decreases in CFU counts were comparable among the four treatment arms; however, the CFU results were statistically inconclusive due to the variability in the control arms. Acquired drug resistance did not occur in any patient. Studies focused on determining a maximum tolerated dose will help elucidate the full anti-TB effect of rifalazil.
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