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

1996 ◽  
Vol 40 (7) ◽  
pp. 1720-1721 ◽  
Author(s):  
E W Hook ◽  
G B Pinson ◽  
C J Blalock ◽  
R B Johnson
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Dose Ranging ◽  
Oral Doses ◽  
To Receive ◽  
Uncomplicated Gonorrhea

Thirty-nine patients with uncomplicated gonorrhea were randomized to receive single, oral 50-, 100-, or 200-mg doses of trovafloxacin (CP-99,219), a new quinolone antibiotic. All 31 evaluable patients were cured of infection. Trovafloxacin was well tolerated. The trovafloxacin MICs at which 50 and 90% of 36 Neisseria gonorrhoeae isolates are inhibited were 0.002 and 0.004 mg/liter, respectively (MIC range, < 0.0005 to 0.008 mg/liter). These preliminary studies suggest that trovafloxacin is effective for the treatment of uncomplicated gonorrhea at single oral doses as low as 50 mg.

Comparison of single-dose oral grepafloxacin with cefixime for treatment of uncomplicated gonorrhea in men. The STD Study Group.

1997 ◽  
Vol 41 (8) ◽  
pp. 1843-1845 ◽  
Author(s):  
E W Hook ◽  
W M McCormack ◽  
D Martin ◽  
R B Jones ◽  
K Bean ◽  
...  
Keyword(s):  
Single Dose ◽  
Neisseria Gonorrhoeae ◽  
Open Study ◽  
Study Group ◽  
Dose Oral ◽  
Male Patients ◽  
Resistant Strains ◽  
Oral Doses ◽  
Uncomplicated Gonorrhea

In a randomized open study, 351 male patients with uncomplicated gonorrhea were given single oral doses of grepafloxacin (400 mg) or cefixime (400 mg). In the 299 microbiologically evaluable patients, urethral infections were cured in 99% (147 of 149) of those receiving grepafloxacin and 97% (145 of 150) of those given cefixime. Eradication rates for both regimens were 100% in the 16% (47 of 299) of participants who were infected with penicillin-resistant Neisseria gonorrhoeae and 97% in the 21% (62 of 299) of participants infected with tetracycline-resistant strains. Grepafloxacin is a well-tolerated alternative to cefixime for treatment of uncomplicated gonorrhea in males.

A Multiple-Dose, Double-Blind Comparison of Intramuscularly and Orally Administered Ketorolac Tromethamine and Ketogan® in Patients with Pain following Orthopaedic Surgery

1994 ◽  
Vol 22 (4) ◽  
pp. 202-217 ◽  
Author(s):  
P H Gebuhr ◽  
M Soelberg ◽  
W Strauss
Keyword(s):  
Orthopaedic Surgery ◽  
Multiple Dose ◽  
Fixed Time ◽  
Double Blind Study ◽  
Standard Regimen ◽  
Double Blind ◽  
Intramuscular Dose ◽  
Blind Comparison ◽  
Oral Doses ◽  
To Receive

In this multiple-dose, double-blind study 100 patients with moderate, severe or very severe pain following orthopaedic surgery were randomly assigned to receive ketorolac, a nonsteroidal anti-inflammatory drug with potent analgesic properties (10 mg), or the standard regimen of Ketogan® (a combination product containing the narcotic analgesic, ketobemidone, plus a spasmolytic agent) by intramuscular injection every 1 – 6 h as needed for pain. When patients were able to tolerate an oral diet and were expected to respond to oral analgesic medication, based on overall pain sensitivity, they were switched to oral doses of the same medication every 4 – 6 h as needed. A maximum of four daily doses of medication was allowed for up to 10 days. The severity of pain was scored on a five-point scale and was recorded before the first intramuscular dose, at fixed time points therafter for up to 6 h and at the end of each day. Both treatments were effective immediately after the first dose and during the subsequent multiple-dose phase. There were no statistically significant differences between ketorolac and Ketogan®. The results show that 10-mg doses of ketorolac in intramuscular injections followed by 10-mg doses of oral ketorolac are as effective as Ketogan® for the treatment of pain following orthopaedic surgery. Ketorolac appears to be better tolerated than Ketogan® since significantly fewer patients reported adverse events ( P = 0.004) when taking ketorolac.

scholarly journals Performance and Verification of a Real-Time PCR Assay Targeting thegyrAGene for Prediction of Ciprofloxacin Resistance in Neisseria gonorrhoeae: TABLE 1

2016 ◽  
Vol 54 (3) ◽  
pp. 805-808 ◽  
Author(s):  
P. Hemarajata ◽  
S. Yang ◽  
O. O. Soge ◽  
R. M. Humphries ◽  
J. D. Klausner
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Real Time ◽  
Real Time Pcr ◽  
The United States ◽  
Test Results ◽  
Pcr Assay ◽  
Content Type ◽  
Agar Dilution ◽  
Ciprofloxacin Resistance ◽  
To Receive

In the United States, 19.2% ofNeisseria gonorrhoeaeisolates are resistant to ciprofloxacin. We evaluated a real-time PCR assay to predict ciprofloxacin susceptibility using residual DNA from the Roche Cobas 4800 CT/NG assay. The results of the assay were 100% concordant with agar dilution susceptibility test results for 100 clinical isolates. Among 76 clinical urine and swab specimens positive forN. gonorrhoeaeby the Cobas assay, 71% could be genotyped. The test took 1.5 h to perform, allowing the physician to receive results in time to make informed clinical decisions.

scholarly journals Dose ranging study of cefpimizole (U-63196E) for treatment of uncomplicated gonorrhea in men.

1986 ◽  
Vol 29 (5) ◽  
pp. 849-851
Author(s):  
E T Sandberg ◽  
P S Pegram ◽  
R E Roddy ◽  
H H Handsfield ◽  
K D Hampton ◽  
...  
Keyword(s):  
Dose Ranging ◽  
Uncomplicated Gonorrhea

Costs Associated with the Inappropriate Route of Administration of Parenteral Histamine2-Receptor Antagonists

1987 ◽  
Vol 21 (11) ◽  
pp. 885-889 ◽  
Author(s):  
Maureen E. Savitsky ◽  
Duane M. Kirking ◽  
Laura A. Cornish ◽  
Danny J. Crudo ◽  
Rosemary R. Berardi ◽  
...  
Keyword(s):  
Rapid Onset ◽  
Parenteral Therapy ◽  
Onset Of Action ◽  
Inappropriate Use ◽  
Parenteral Route ◽  
Medication Costs ◽  
El Alto ◽  
Pour Cent ◽  
Oral Doses ◽  
To Receive

The objectives were to assess the parenteral route for cimetidine and ranitidine and to determine excess medication costs associated with inappropriate use. Criteria were based on clinical situations that do not permit oral therapy, result in questionable drug absorption, or require a more rapid onset of action. The parenteral route was assessed as appropriate, inappropriate, or questionable. During two months, parenteral therapy was prescribed for 199 adult inpatients. Initially, 63 percent received the parenteral form appropriately; only 16 percent continued to receive the parenteral form appropriately throughout therapy. Less than half of the parenteral doses were determined to be appropriate. A major reason appears to be that orders are not changed as patients' conditions improve. Excess medication costs attributed to inappropriate parenteral therapy for the study period amounted to $6796 or $8002, depending on whether questionable doses were considered appropriate or inappropriate, respectively. An annual projected savings of $40776 or $48012 could be achieved if oral doses had been administered in place of inappropriate parenteral therapy. Extracto El aumento en la utilización de formas de dosificación inyectables y el alto costo relacionado con la administración por la ruta parenteral motivó a los autores a realizar un estudio con los antagonistas de receptores H2. Los autores presentan una evaluación de la utilización de cimetidina y ranitidina por la ruta parenteral enfatizando los costos excesivos asociados con la administración de los medicamentos. Los criterios utilizados para evaluar el uso de la ruta parenteral incluyeron: Situaciones clínicas que no permitían la administración por la vía oral, situaciones en que se altera la absorción gastrointestinal, o situaciones en donde se requiere un inicio de acción rápido. La ruta de administración fue evaluada como adecuada, inadecuada, o cuestionable. Durante dos meses, la terapia parenteral fue prescrita en 199 pacientes adultos hospitalizados. En el 63 por ciento de los pacientes fue apropiada la ruta parenteral inicialmente, pero sólo el 16 por ciento continuó recibiendo esta terapia adecuadamente. El costo total en exceso atribuído al uso inadecuado de la terapia parenteral en estos 199 pacientes fue $6796 ó $8002 dependiendo si las dosis de la categoría cuestionable fueron consideradas adecuadas o inadecuadas respectivamente. El uso de dosis orales de cimetidina y ranitidina en lugar de la utilización inadecuada de la forma parenteral puede significar una econom***ía anual estimada de $41000 a $48000 en los costos de administración para esta institución. Resume La cimétidine et la ranitidine sont des antagonistes des récepteurs H2 et sont toutes deux disponibles sous forme orale et injectable aux États-Unis. Il semble que chez les patients hospitalisés, la voie d'administration parentérale soit utilisée fréquemment même si le patient est capable d'ingérer une médication orale. Les objectifs de l'étude sont d'évaluer l'utilization de la voie d'administration parentérale pour la cimétidine et la ranitidine et de déterminer les coûts supplémentaires associés à son utilisation inappropriée. Les critères utilisés pour évaluer la justesse du choix de la voie parentérale sont basés sur la présence de situations cliniques ne permettent pas une thérapie orale, résultant en une absorption erratique ou nécessitant un début d'action rapide. En fonction de ces critères, l'utilisation de la voie parentérale est jugée appropriée, inappropriée ou discutable. Les auteurs évaluent la justesse du choix de la voie parentérale chez 199 patients adultes. En début de traitement, l'usage de la voie parentérale est approprié chez 63 pour cent des patients; toutefois la poursuite du médicament par voie parentérale s'avère adéquate chez seulement 16 pour cent d'entre eux. Au total, moins de la moitié des doses parentérales administrées sont jugées appropriées. L'une des raisons pouvant expliquer ce phénomène est l'absence d'une modification de l'ordonnance lorsque la condition du patient s'améliore. Les coûts supplémentaires (en médicament seulement) attribués à l'utilisation inappropriée de la voie parentérale pour la durée de l'étude se chiffrent à $6796 ou $8002 selon que l'on considère les doses discutables comme appropriées ou inappropriées. Annuellement, des épargnes de $40776 ou $48000 pourraient être réalisées si la voie orale était utilisée à la place d'une thérapie parentérale inappropriée.

scholarly journals Comparison of single-dose cefuroxime axetil with ciprofloxacin in treatment of uncomplicated gonorrhea caused by penicillinase-producing and non-penicillinase-producing Neisseria gonorrhoeae strains.

1996 ◽  
Vol 40 (12) ◽  
pp. 2775-2780 ◽  
Author(s):  
E M Thorpe ◽  
J R Schwebke ◽  
E W Hook ◽  
A Rompalo ◽  
W M McCormack ◽  
...  
Keyword(s):  
Single Dose ◽  
Oral Dose ◽  
Confidence Interval ◽  
Neisseria Gonorrhoeae ◽  
Single Oral Dose ◽  
Cefuroxime Axetil ◽  
Female Patients ◽  
Male Patients ◽  
Males And Females ◽  
Uncomplicated Gonorrhea

A randomized, multicenter, investigator-blind trial was conducted to compare the efficacies of cefuroxime axetil and ciprofloxacin for treatment of patients with uncomplicated gonorrhea caused by penicillinase-producing Neisseria gonorrhoeae (PPNG). A total of 832 patients (434 females and 398 males) received a single oral dose of cefuroxime axetil (1,000 mg [417 patients]) or ciprofloxacin (500 mg [415 patients]). N. gonorrhoeae was eradicated from the cervix in 114 of 118 (97%) and 118 of 119 (99%) bacteriologically evaluable females treated with cefuroxime axetil and ciprofloxacin, respectively (P = 0.213; difference, -2%; 95% confidence interval, -6 to 1%), and from the urethra in 154 of 166 (93%) and 171 of 171 (100%) bacteriologically evaluable male patients treated with cefuroxime axetil and ciprofloxacin, respectively (P < 0.001; difference, -7%; 95% confidence interval, -11 to -3%). Both treatments were effective in eradicating N. gonorrhoeae in females with rectal infections (cefuroxime axetil, 29 of 30 [97%]; ciprofloxacin, 25 of 25 [100%]; P = 1.00). In small numbers of patients, cefuroxime axetil was less effective than ciprofloxacin in treating males with pharyngeal infections (eradication in 4 of 10 and in 8 of 8 patients, respectively; P = 0.013). PPNG was eradicated from the cervix in 22 of 23 (96%) and 32 of 32 (100%) bacteriologically evaluable female patients treated with cefuroxime axetil and ciprofloxacin, respectively (P = 0.418; difference, -4%; 95% confidence interval, -13 to 4%), and from the urethra in 35 of 36 (97%) and 34 of 34 (100%) bacteriologically evaluable male patients treated with cefuroxime axetil and ciprofloxacin, respectively (P = 1.00; difference, -3%; 95% confidence interval, -8 to 3%). The incidences of drug-related adverse events were similar for the two study drugs. In summary, treatment with a single oral dose of cefuroxime axetil is as effective as treatment with a single oral dose of ciprofloxacin in eradicating PPNG from males and females with uncomplicated gonorrhea (urethral and endocervical), and both regimens are well-tolerated. However, in the present study, cefuroxime axetil was less effective than ciprofloxacin in treating urethral gonococcal infections in male patients, although both study drugs were highly effective in treating cervical gonococcal infections in female patients.

Therapy of Uncomplicated Gonorrhea Due to Antibiotic-Resistant Neisseria gonorrhoeae

1988 ◽  
Vol 15 (4) ◽  
pp. 234-243 ◽  
Author(s):  
STEPHEN J. KRAUS ◽  
GLADYS H. REYNOLDS ◽  
ROBERT T. ROLFS
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Antibiotic Resistant ◽  
Uncomplicated Gonorrhea

Pharmacokinetics/pharmacodynamics (PK/PD), safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric subjects.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 93-93
Author(s):  
Jaume Mora ◽  
Miguel Valero ◽  
Cara DiCristina ◽  
Mandy Jin ◽  
Anne Chain ◽  
...  
Keyword(s):  
Emetogenic Chemotherapy ◽  
Study Medication ◽  
Open Label ◽  
Common Drug ◽  
Fourth Dose ◽  
Dose Ranging ◽  
To Receive ◽  
Higher Doses ◽  
Clinical Trial Information ◽  
Dose Proportional

93 Background: Fosaprepitant is approved to prevent CINV in adults. The aim of this study was to determine appropriate fosaprepitant dosing in children. Methods: This was a phase 2b, multicenter, randomized, dose-ranging study to evaluate PK/PD, safety, and tolerability of a single dose of fosaprepitant administered concomitantly with ondansetron, with or without dexamethasone. Eligible subjects were newborn to 17 years of age who were scheduled to receive emetogenic chemotherapy for a documented malignancy. PK/PD data were collected in cycle 1 only. The study was designed to compare 3 doses of fosaprepitant versus placebo in 2 to 17 year olds, with an open-label amendment evaluating a fourth dose in <12 year olds. Pediatric exposures were compared with historical adult PK data. Results: 234 subjects were enrolled and received study medication (Table). All but one completed cycle 1. One subject (5 mg/kg regimen) discontinued because of anaphylactic reaction. In 167 subjects with evaluable PK data, aprepitant exposures were dose proportional. Adolescents (12-17 years) receiving fosaprepitant 150 mg had exposures similar to adults at the same dose. Owing to a higher clearance in children <12 years old, a higher weight-normalized dose (5 mg/kg) was necessary to achieve comparable exposures. The AE profile was typical of subjects with cancer receiving emetogenic chemotherapy. The most common drug-related AE was hiccups. Conclusions: In pediatric subjects receiving fosaprepitant to prevent CINV, aprepitant exposures were dose proportional. Subjects <12 years old required higher doses to achieve exposures comparable with adults. Fosaprepitant was well tolerated in this population. Clinical trial information: NCT01697579. [Table: see text]

scholarly journals Preclinical Toxicity Screening of Intrathecal Oxytocin in Rats and Dogs

2014 ◽  
Vol 120 (4) ◽  
pp. 951-961 ◽  
Author(s):  
Tony L. Yaksh ◽  
Shotaro Hobo ◽  
Christopher Peters ◽  
Kent G. Osborn ◽  
Philip J. Richter ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Spinal Cord ◽  
Heart Rate ◽  
Behavioral Assessment ◽  
Toxicity Screening ◽  
Histologic Evidence ◽  
Behavioral Studies ◽  
Behavioral Assessments ◽  
Dose Ranging ◽  
To Receive

Abstract Background Anatomic, physiologic, and behavioral studies in animals suggest that spinally released oxytocin should produce analgesia in humans and may also protect from chronic pain after injury. In this article, the authors report preclinical toxicity screening of oxytocin for intrathecal delivery. Methods Intrathecal oxytocin, 11 μg (6 U) or vehicle, was injected intrathecally in 24 rats, followed by frequent behavioral assessment and histologic examination of spinal contents 2 or 14 days after injection. In three dogs, a range of intrathecal oxytocin doses (18 to 550 μg in 0.5 ml) was injected followed by physiologic, biochemical, and behavioral assessments. Ten dogs were then randomized to receive five daily injections of intrathecal oxytocin, 550 μg in 0.5 ml, or vehicle with similar assessments and, necropsy and histologic analysis were conducted 2 days later. Results In rats, intrathecal oxytocin resulted in transient scratching and itching behaviors, without other differences from vehicle. There was no behavioral, gross anatomic, or histologic evidence of neurotoxicity. Dose ranging in dogs suggested mild effects on motor tone, blood pressure, and heart rate at the 550 μg dose. Repeated boluses in dogs did not produce behavioral, biochemical, neurological, gross anatomic, or histologic evidence of neurotoxicity. Conclusions Substances, including natural neurotransmitters, may be toxic when administered in pharmacologic doses in the spinal cord. This preclinical toxicity screen in two species suggests that bolus injections of oxytocin in concentrations up to 1,100 μg/ml are unlikely to cause neurotoxicity. The authors also support cautious clinical application of intrathecal oxytocin under regulatory supervision.

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