Dose-ranging study of CP-99,219 (trovafloxacin) for treatment of uncomplicated gonorrhea

Hook, Edward W.; Pinson, Gloria B.; Blalock, C J; Johnson, Raymond B.

doi:10.1128/aac.40.7.1720

Cited by 14 publications

(6 citation statements)

References 7 publications

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“…Abstracts are available regarding the agent in nosocomial pneumonia, community-acquired pneumonia requiring hospitalization, and acute bacterial exacerbation of chronic bronchitis 52-54 and two articles described its efficacy in uncomplicated gonorrhea. 55,56 No information is available for acute sinusitis, cervicitis, prostatitis, pelvic inflammatory disease, skin and skin structure infections, surgical prophylaxis, cystitis, or gonorrhea besides that supplied by the manufacturer. Of note, trovafloxacin is indicated only for uncomplicated urinary tract infections (cystitis), and no data are available for more complicated infections such as pyelonephritis.…”

Section: Clinical Efficacy Trialsmentioning

confidence: 99%

“…Success rates (cure or improvement) occurred in 98% and 100% of men In an open, randomized noncomparative, doseranging study, 39 patients (16 men, 23 women) with gonorrhea were randomly assigned to receive a single oral 50-, 100-, or 200-mg dose of trovafloxacin, with follow-up to assess response 5-9 days later. 56 Of 31 patients, Neisseria gonorrhoeae was isolated from the genital sites of 30 patients, from rectal infections in 5, and from pharyngeal infections in 8. Of the remaining eight patients, seven had negative cultures and one was lost to follow-up.…”

Section: Uncomplicated Gonorrheamentioning

confidence: 99%

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Trovafloxacin: An Overview

Garey

Amsden

1999

Pharmacotherapy

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Trovafloxacin, a new synthetic naphthyridine fluoroquinolone antibiotic, is a broad-spectrum agent available orally and intravenously. It was recently approved by the Food and Drug Administration for the treatment of selected pulmonary, surgical, intraabdominal, gynecologic, pelvic, skin, and urinary tract infections. Its spectrum of activity includes aerobic gram-positive and gram-negative organisms as well as anaerobic pathogens. It is rapidly absorbed after oral administration, achieves good tissue and cerebrospinal fluid penetration, and has a half-life that allows once-daily dosing. It is hepatically metabolized, and dosage adjustments are necessary for patients with severe hepatic dysfunction but not for those with mild or moderate dysfunction or renal dysfunction. The drug has a favorable safety profile, and a high tendency for transient first-dose dizziness and/or lightheadedness in young women. Similar to other quinolones, trovafloxacin should not be taken with antacids that contain aluminum or magnesium, sucralfate, or ferrous sulfate. Trovafloxacin may prove beneficial as it allows for oral or intravenous monotherapy against indicated infections that normally require multidrug, broad-spectrum antibiotic coverage.

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Section: Clinical Efficacy Trialsmentioning

confidence: 99%

Section: Uncomplicated Gonorrheamentioning

confidence: 99%

Trovafloxacin: An Overview

Garey

Amsden

1999

Pharmacotherapy

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“…Overall, 91.3% of the bacterial strains isolated were eradicated by treatment with sparfloxacin (204). Trovafloxacin: The efficacy of trovafloxacin in the treatment of genitourinary tract infections has been evaluated in two trials (Table 7.6) (205,206). The first of these was a noncomparative dose ranging study that examined the use of trovafloxacin in the treatment of uncomplicated gonorrhea.…”

mentioning

confidence: 99%

The New Fluoroquinolones: A Critical Review

Zhanel

Walkty

Vercaigne

et al. 1999

Canadian Journal of Infectious Diseases and Medical Microbiolog

106

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“…In vivo, trova-floxacin was shown to have significant antimicrobial activity in numerous experimental infection models (1,18,19,23,32,34). Early clinical studies have demonstrated its effectiveness in a variety of infections, including uncomplicated gonorrhea, at single oral doses as low as 50 mg (22).…”

mentioning

confidence: 99%

Pharmacokinetics of [ ¹⁸ F]Trovafloxacin in Healthy Human Subjects Studied with Positron Emission Tomography

Fischman

Babich

Bonab

et al. 1998

Antimicrob Agents Chemother

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Tissue pharmacokinetics of trovafloxacin, a new broad-spectrum fluoroquinolone antimicrobial agent, were measured by positron emission tomography (PET) with [18F]trovafloxacin in 16 healthy volunteers (12 men and 4 women). Each subject received a single oral dose of trovafloxacin (200 mg) daily beginning 5 to 8 days before the PET measurements. Approximately 2 h after the final oral dose, the subject was positioned in the gantry of the PET camera, and 1 h later 10 to 20 mCi of [18F]trovafloxacin was infused intravenously over 1 to 2 min. Serial PET images and blood samples were collected for 6 to 8 h, starting at the initiation of the infusion. Drug concentrations were expressed as the percentage of injected dose per gram, and absolute concentrations were estimated by assuming complete absorption of the final oral dose. In most tissues, there was rapid accumulation of the radiolabeled drug, with high levels achieved within 10 min after tracer infusion. Peak concentrations of more than five times the MIC at which 90% of the isolates are inhibited (MIC90) for most members ofEnterobacteriaceae and anaerobes (>10-fold for most organisms) were achieved in virtually all tissues, and the concentrations remained above this level for more than 6 to 8 h. Particularly high peak concentrations (micrograms per gram; mean ± standard error of the mean [SEM]) were achieved in the liver (35.06 ± 5.89), pancreas (32.36 ± 20.18), kidney (27.20 ± 10.68), lung (22.51 ± 7.11), and spleen (21.77 ± 11.33). Plateau concentrations (measured at 2 to 8 h; micrograms per gram; mean ± SEM) were 3.25 ± 0.43 in the myocardium, 7.23 ± 0.95 in the lung, 11.29 ± 0.75 in the liver, 9.50 ± 2.72 in the pancreas, 4.74 ± 0.54 in the spleen, 1.32 ± 0.09 in the bowel, 4.42 ± 0.32 in the kidney, 1.51 ± 0.15 in the bone, 2.46 ± 0.17 in the muscle, 4.94 ± 1.17 in the prostate, and 3.27 ± 0.49 in the uterus. In the brain, the concentrations (peak, ∼2.63 ± 1.49 μg/g; plateau, ∼0.91 ± 0.15 μg/g) exceeded the MIC90s for such common causes of central nervous system infections asStreptococcus pneumoniae (MIC90, <0.2 μg/ml), Neisseria meningitidis (MIC90, <0.008 μg/ml), and Haemophilus influenzae(MIC90, <0.03 μg/ml). These PET results suggest that trovafloxacin will be useful in the treatment of a broad range of infections at diverse anatomic sites.

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Dose-ranging study of CP-99,219 (trovafloxacin) for treatment of uncomplicated gonorrhea

Cited by 14 publications

References 7 publications

Trovafloxacin: An Overview

Trovafloxacin: An Overview

The New Fluoroquinolones: A Critical Review

Pharmacokinetics of [ ¹⁸ F]Trovafloxacin in Healthy Human Subjects Studied with Positron Emission Tomography

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Dose-ranging study of CP-99,219 (trovafloxacin) for treatment of uncomplicated gonorrhea

Cited by 14 publications

References 7 publications

Trovafloxacin: An Overview

Trovafloxacin: An Overview

The New Fluoroquinolones: A Critical Review

Pharmacokinetics of [ 18 F]Trovafloxacin in Healthy Human Subjects Studied with Positron Emission Tomography

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Product

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Pharmacokinetics of [ ¹⁸ F]Trovafloxacin in Healthy Human Subjects Studied with Positron Emission Tomography