College women and condom use, 1975-1995.
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Adult↗
Biomedical subjects
W M McCormack
Publications and source records attributed to W M McCormack.
Evaluation of a deoxyribonucleic acid probe for the detection of Trichomonas vaginalis in vaginal secretions.
OBJECTIVE: Our purpose was to compare Affirm VP, a new deoxyribonucleic acid probe test, with standard "wet preparation" microscopic examinations and culture for the identification of Trichomonas vaginalis organisms in vaginal secretions. STUDY DESIGN: We examined vaginal samples from 615 women with symptoms or signs of vaginitis for T. vaginalis using the deoxyribonucleic acid probe test, microscopic examination of wet preparations of vaginal secretions, and culture in modified Diamond's medium. RESULTS: T. vaginalis was identified in specimens from 95 (15.4%) of the 615 patients. Cultures in Diamond's medium identified 93 (98%) of the 95 infected patients. Vaginal wet preparation identified 76 (80%) of the infected women. The deoxyribonucleic acid probe test detected 86 (90.5%) of the 95 infected patients. There was one false-positive deoxyribonucleic acid probe test (specificity 519/520: 99.8%). CONCLUSION: The Affirm VP deoxyribonucleic acid probe test had a sensitivity of 90% and a specificity of 99.8% for the identification of T. vaginalis organisms in women with symptoms with a high prevalence of trichomoniasis. Such a nonculture test may be of considerable benefit in diagnosing T. vaginalis infections, especially in settings where microscopy, culture, or both are unavailable, inconvenient, or unreliably performed.
Animals↗
Comparison of single-dose cefuroxime axetil with ciprofloxacin in treatment of uncomplicated gonorrhea caused by penicillinase-producing and non-penicillinase-producing Neisseria gonorrhoeae strains.
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.
Adolescent↗
Azithromycin for empirical treatment of the nongonococcal urethritis syndrome in men. A randomized double-blind study.
OBJECTIVE: To evaluate the use of single-dose azithromycin for empirical treatment of nongonococcal urethritis. DESIGN: Randomized, double-blind, multicenter trial comparing azithromycin vs doxycycline therapy, with a 2:1 randomization ratio. Patients were evaluated clinically and microbiologically for Chlamydia trachomatis and Ureaplasma urealyticum infection before therapy and at 2 and 5 weeks after study entry. SETTING: Eleven sexually transmitted disease clinics throughout the United States. PATIENTS: A total of 452 men aged 18 years or older with symptomatic nongonococcal urethritis of less than 14 days' duration. INTERVENTION: Patients were treated with either 1.0 g of azithromycin as a single oral dose or 100 mg of doxycycline taken orally twice daily for 7 days. MAIN OUTCOME MEASURES: Clinical resolution of symptoms and signs of nongonococcal urethritis, microbiological cure of C trachomatis and U urealyticum, and occurrence of adverse experiences. RESULTS: Of the 452 patients enrolled, 248 in the azithromycin-treated group and 123 in the doxycycline-treated group were evaluable for clinical response. The two treatment groups were comparable in terms of age, weight, ethnic distribution, sexual preference, sexual activity, and history of prior nongonococcal urethritis or gonorrhea. Sixteen percent of the azithromycin group and 24% of the doxycycline group were culture positive for C trachomatis before therapy, while 38% and 28%, respectively, were culture positive for U urealyticum. The cumulative clinical cure rate was 81% (95% confidence interval [CI], 75% to 85%) in the azithromycin-treated group and 77% (95% CI, 69% to 84%) in the doxycycline-treated group. Clinical cure rates in the two groups were also comparable when patients were stratified by presence or absence of infection with C trachomatis or U urealyticum prior to therapy. Among those infected with C trachomatis, overall microbiological cure rates were 83% (95% CI, 65% to 94%) for azithromycin-treated patients (n = 30) and 90% (95% CI, 68% to 98%) for doxycycline-treated patients (n = 21). Among those infected with U urealyticum, overall microbiological cure rates were 45% (95% CI, 34% to 57%) for azithromycin-treated patients (n = 75) and 47% (95% CI, 30% to 65%) for doxycycline-treated patients (n = 32). Adverse reactions were generally mild to moderate and occurred in 23% of the azithromycin-treated group and 29% of the doxycycline-treated group. CONCLUSIONS: For empirical treatment of the acute nongonococcal urethritis syndrome in men, a single oral dose of azithromycin was as effective as a standard 7-day course of doxycycline in achieving clinical cure. Further, clinical cure rates were comparable with either regimen, regardless of the presence or absence of Chlamydia or Ureaplasma infection.
Adult↗
Comparison of azithromycin and ceftriaxone for the treatment of chancroid.
We conducted a randomized, unblinded, prospective study designed to determine the efficacy of single-dose azithromycin for the treatment of chancroid. Men and women 16 years of age and older who had darkfield-negative genital ulcers that were clinically suspected to be caused by Haemophilus ducreyi and who attended urban sexually transmitted disease clinics or presented to hospital emergency departments were enrolled in the study. Patients were randomized to receive 250 mg of ceftriaxone im or 1 g of azithromycin orally, both given as a single dose. They were followed for up to 23 days after treatment. For 65 patients, cultures were positive for H. ducreyi; there were 68 patients whose cultures were negative for both H. ducreyi and herpes simplex virus and who had no evidence of syphilis. All 133 patients returned for at least one follow-up visit. At the time of the last follow-up visit, all 32 patients whose cultures were positive for H. ducreyi and who were treated with azithromycin were clinically cured. In all 33 culture-positive cases in which ceftriaxone was used, there was either clinical improvement or cure at the time of the patient's last follow-up visit. In addition, azithromycin and ceftriaxone were equally effective in healing ulcers for which cultures were negative. We conclude that a single 1-g oral dose of azithromycin is as effective as a 250-mg im dose of ceftriaxone for the treatment of chancroid.
Administration, Oral↗
Bacterial vaginosis in lesbians: a sexually transmitted disease.
Sexual transmission of bacterial vaginosis (BV), a common syndrome in sexually active women, has not been previously established. Because no male counterpart for BV has been found, a population of lesbians is an ideal one in which to test the hypothesis that BV is sexually transmitted. We studied 103 homosexual women (lesbians) who sought gynecologic care at a community clinic and in a private gynecology practice in New York City. Participants were asked to refer their sexual partners for evaluation. In this cross-sectional prevalence study, all participants were evaluated for the presence of BV, and pairs of monogamous sexual partners were analyzed for concordance of their vaginal secretions. Twenty-nine (28.7%) of the 101 participants from whom satisfactory vaginal wash samples were available had BV. There were 21 pairs of monogamous partners. Of 11 index women who had BV, eight (72.7%) had partners who also had BV. Of 10 index women who did not have BV, only one (10%) had a partner with BV. The likelihood of a partner's having BV was 19.7 times greater if the index case had BV (P < .008; 95% CI, 2.1-588.0). We conclude that with respect to BV, lesbians in monogamous relationships usually have concordant vaginal secretions. This concordance probably reflects the sexual transmission of BV between lesbians.
Female↗
Diagnosis of Chlamydia trachomatis urethral infection in symptomatic and asymptomatic men by testing first-void urine in a ligase chain reaction assay.
A multicenter study compared ligase chain reaction (LCR) of Chlamydia trachomatis plasmid DNA with culture of urethral swab specimens from 542 men (study A); a second study (B) compared LCR of first-void urine (FVU) with urethral swab cultures from 1043 men. Discordant results were resolved with direct fluorescent antibody staining of sediments from the FVU or urethral culture specimen and with a second LCR directed against a fragment of the major outer membrane protein gene. Test performance was calculated on the basis of an expanded reference standard. The LCR plasmid assay had a sensitivity of 98.0% in study A and 93.5% in study B; specificity was 99.8%-100%. The sensitivity of culturing urethral swabs from all study sites was 68.2% (range by sites, 40.0%-84.6%). The presence or absence of urethral symptoms did not alter the results. Use of this LCR test should allow more meaningful investigation and treatment of C. trachomatis infections in men.
Bacteriuria↗
Sexually transmitted diseases in HIV-infected persons.
It appears incontestable that there is a link between genital ulcer disease and HIV infection. On the one hand the natural history and response to therapy of syphilis, HSV-2, and chancroid are all modified by the immunosuppressive effects of HIV infection. On the other hand, HIV transmission is probably facilitated by the disruption of the normal epithelial barriers of the genital organs caused by these ulcerative infections. Information is somewhat less convincing that a similar association exists between the nonulcerative STDs (trichomonas, gonorrhea, chlamydial infections) and HIV. Conceptually, the mucosal inflammation associated with these infections might serve as a focus for HIV transmission. The available data, though suggestive, do not strongly support this contention. Theoretically though, even a small risk might potentially result in significant HIV transmission given the prevalence of nonulcerative STDs. These infectious processes do not appear to be markedly altered by HIV induced immunosuppression. The ability of HPV to cause dysplastic changes in cervical and anal tissue did not require the AIDS epidemic to come to light. In HIV infection, disruptions of immunoregulatory processes, which might ordinarily control the progression of potentially malignant cell lines, have created fertile ground for an increasing incidence of premalignant and malignant cytologic changes. The mutual impact these processes have or may have on one another requires that clinicians who care for patients with either HIV infection or with STDs should be thoroughly familiar with both and not consider them somehow exclusive of one another. Efforts toward the prevention and control of STDs should be considered important in the control and prevention of HIV transmission.
Chancroid↗
Multicenter trial of fleroxacin versus ceftriaxone in the treatment of uncomplicated gonorrhea.
In a multicenter, randomized, open, comparative trial, patients with uncomplicated gonorrhea were treated with 400 mg of oral fleroxacin or 250 mg of intramuscular ceftriaxone. A total of 458 men and 447 women were enrolled. Of these, 312 men (68%) and 245 women (55%) were evaluable for efficacy. The treatment groups were demographically similar. Among evaluable men, fleroxacin eradicated 154 of 155 (99%; 95% confidence interval [CI]: 98.1-100%) urethral and 2 of 2 pharyngeal infections, while ceftriaxone eradicated 156 of 156 (95% CI: 99.4-100%) urethral and 5 of 5 pharyngeal infections. Among evaluable women, fleroxacin eradicated 127 of 128 (99%; 95% CI: 97.7-100%) cervical, 20 of 20 anorectal, 16 of 16 urethral, and 7 of 7 pharyngeal infections, while ceftriaxone eradicated 108 of 108 (95% CI: 99.1-100%) cervical, 24 of 24 anorectal, 25 of 25 urethral, and 9 of 9 pharyngeal infections. Adverse events were reported by 68 (16%) of 426 subjects in the fleroxacin group and 20 (5%) of 380 in the ceftriaxone group (p < 0.0001). The most common adverse events reported by the patients who received fleroxacin were nausea (5%), headache (3%), and vaginitis (3%). One patient had severe vomiting, 19 participants had adverse reactions classified as moderate, and 48 patients had mild adverse reactions. Fleroxacin was highly effective in the treatment of uncomplicated gonorrhea and represents an oral alternative to ceftriaxone. Adverse events were more common with fleroxacin than with ceftriaxone.
Administration, Oral↗
Susceptibility of mycoplasmas to antimicrobial agents: clinical implications.
Mycoplasmas are susceptible to antimicrobial agents that affect DNA, RNA, protein synthesis, or the integrity of the cell membrane. Mycoplasmas are not susceptible to agents that interfere with synthesis of folic acid or that act on the cell wall. Tetracyclines, erythromycin, clindamycin, chloramphenicol, aminoglycosides, and fluoroquinolones have been shown to have activity against one or more mycoplasmal species. Tetracycline-resistant isolates of Mycoplasma hominis and Ureaplasma urealyticum contain DNA sequences homologous to the streptococcal determinant tetM. Resistance to tetracycline in vitro is associated with failure of tetracycline treatment to eradicate M. hominis and U. urealyticum from the human urogenital tract.
Drug Resistance, Microbial↗
Identification of mycoplasmas in urine from persons infected with human immunodeficiency virus.
Voided urine samples from persons with and without human immunodeficiency virus (HIV) infection were examined for mycoplasmas. Mycoplasma hominis organisms were identified in cultures of urine from 32 (18%) of 180 HIV-positive individuals and from 8 (21%) of 38 HIV-negative individuals. In contrast, glucose-utilizing mycoplasmas were identified in the urine of 30 (17%) of the HIV-positive individuals and in none of those who were HIV-negative. Assays of growth inhibition around disks containing specific antisera identified 14 of the 30 glucose-utilizing mycoplasmas as Mycoplasma fermentans. Four isolates were presumptively identified as Mycoplasma pirum. Growth on solid media was insufficient to permit the identification of the species of the other 12 isolates by growth inhibition.
Adult↗
Mycoplasma hominis and Ureaplasma urealyticum in neonates with suspected infection.
The role of genital mycoplasmas in the pathogenesis of neonatal infection is incompletely understood. We performed nasopharyngeal, blood and cerebrospinal fluid (CSF) cultures for Mycoplasma hominis and Ureaplasma urealyticum in 69 neonates who underwent a diagnostic workup for suspected sepsis. The mean gestational age was 35.9 weeks (range, 25 to 42 weeks) with a mean birth weight of 2386 g (range, 652 to 4420 g). Twenty-seven infants (39.1%) had positive nasopharyngeal cultures; 6 were positive for M. hominis, 10 for U. urealyticum and 11 for both organisms. Seven (26%) of these 27 patients developed chronic lung disease compared with 2 (4.7%) infants in the non-colonized group. Nine infants had positive CSF cultures for M. hominis and one infant had a positive CSF culture for U. urealyticum. All blood cultures were sterile. One of the infants with a positive CSF culture for M. hominis had clinical evidence of systemic infection. All of the infants were treated with antibiotic agents that were not active against mycoplasmas. These data indicate that genital mycoplasmas can be found commonly in the CSF and nasopharynx of infants with suspected sepsis. Their etiologic role in the causation of infection and chronic lung disease, however, remains unclear.
Cerebrospinal Fluid↗
Comparison of the Syva MicroTrak enzyme immunoassay and Gen-Probe PACE 2 with cell culture for diagnosis of cervical Chlamydia trachomatis infection in a high-prevalence female population.
Culture is currently considered the "gold standard" for detecting Chlamydia trachomatis infections. We evaluated the Syva MicroTrak enzyme immunoassay (EIA) and Gen-Probe PACE 2 tests, which detect chlamydial antigens and rRNA, respectively. These assays were compared with each other and with culture for the detection of C. trachomatis in cervical specimens obtained from 217 women attending a clinic for sexually transmitted diseases. The prevalence of infection was 22.1% by culture. The sensitivity, specificity, and positive and negative predictive values were 79.2, 98.2, 92.6, and 94.3%, respectively, for EIA. For PACE 2, the respective values were 77.1, 97.6, 90.1, and 93.7%. After corrections for two false-negative cultures, the sensitivities and specificities were 80 and 99.4%, respectively, for the EIA and 78 and 98.8%, respectively, for the probe assay. Quantitative evaluation of the results showed that false-negative results with either assay were associated with cultures that had low inclusion counts or were negative without subpassage. Analysis of nonculture results revealed that 2.3% of the EIA results and 4.6% of the probe assay results were within +/- 30% of the respective assay cutoff values. These included four false-negative (one EIA and three probe) and two false-positive (one EIA and one probe) results. The Syva MicroTrak EIA and the Gen-Probe PACE 2 assay are comparable to but significantly less sensitive than culture. Use of a grey zone may help identify the need for repeat or confirmatory testing.
Adolescent↗
Management of chronic urethral symptoms in men.
We describe 20 men who were referred because of chronic urogenital symptoms. They had been previously seen by zero to six physicians (mean, 1.8 physicians) and had been treated with zero to five courses of antimicrobial agents (mean, 2.4 courses) without relief of their symptoms. Results of physical examinations of all patients were normal. An extensive evaluation failed to reveal any objective evidence of urethral inflammation. Cultures for Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum, and Trichomonas vaginalis were uniformly negative. No additional antimicrobial agents were prescribed. Data from follow-up questionnaires filled out by 10 of these men 5-28 months later (mean, 11.8 months) disclosed the disappearance of symptoms in three and the reduction of symptoms in four. Chronic urethral symptoms may occur in the absence of objective evidence of inflammation and infection with known urethral pathogens. Observation without antimicrobial therapy is the treatment of choice for such patients.
Chronic Disease↗
A comparison of single-dose cefixime with ceftriaxone as treatment for uncomplicated gonorrhea. The Gonorrhea Treatment Study Group.
BACKGROUND: Because of the widespread existence of Neisseria gonorrhoeae resistant to penicillin or tetracycline, ceftriaxone is now recommended for the treatment of gonorrhea. There is, however, a need for effective antibiotics that can be administered orally as an alternative to ceftriaxone, which requires intramuscular administration. Cefixime is an orally absorbed cephalosporin that is active against resistant gonococci and has pharmacokinetic activity suitable for single-dose administration. METHODS AND RESULTS: In a randomized, unblinded multicenter study of 209 men and 124 women with uncomplicated gonorrhea, we compared three single-dose treatment regimens: 400 mg or 800 mg of cefixime, administered orally, and 250 mg of ceftriaxone administered intramuscularly. The overall cure rates were 96 percent for the 400-mg dose of cefixime (89 of 93 patients) (95 percent confidence interval, 93.5 percent to 97.8 percent); 98 percent for the 800-mg dose of cefixime (86 of 88 patients) (95 percent confidence interval, 94.6 percent to 100 percent); and 98 percent for ceftriaxone (92 of 94 patients) (95 percent confidence interval, 94.9 to 100 percent). The cure rates were similar in men and women, and pharyngeal infection was eradicated in 20 of 22 patients (91 percent). Thirty-nine percent of 303 pretreatment gonococcal isolates had one or more types of antimicrobial resistance; the efficacy of all three regimens was independent of the resistance pattern. Chlamydia trachomatis infection persisted in at least half the patients infected in each treatment group. All three regimens were well tolerated. CONCLUSIONS: In the treatment of uncomplicated gonorrhea, a single dose of cefixime (400 or 800 mg) given orally appears to be as effective as the currently recommended regimen of ceftriaxone (250 mg given intramuscularly).
Administration, Oral↗
Sexually transmitted diseases in postpubertal female rape victims.
Seventy-six postpubertal women were referred from a municipal hospital emergency room within 60 h of sexual assault for evaluation. Of the 76 victims, 20 (26%) had active Chlamydia trachomatis infection detected by culture (11 subjects), a fourfold serologic titer rise (6), or both (3). The risk of acquiring C. trachomatis infection after sexual assault was 3%-16%. Pelvic inflammatory disease was detected in 8 (11%) of the 76 victims. Bacterial vaginosis was diagnosed in 38 women (50%), at least 8 of whom appeared to have been infected during the assault. Trichomoniasis was found in 17 victims (22%), at least 5 of whom may have acquired the infection at the time of the assault. In view of the high rates of these infections and the poor compliance with follow-up (76% [58/76] kept their appointments), all postpubertal victims of sexual assault should be offered treatment with ceftriaxone, 250 mg intramuscularly, followed by 100 mg of oral doxycycline and 500 mg of oral metronidazole twice daily for 7 days.
Adolescent↗
HIV infection, genital ulcer disease, and crack cocaine use among patients attending a clinic for sexually transmitted diseases.
BACKGROUND: Recently there has been a rise in genital ulcer disease (GUD) in urban minority heterosexuals in the United States. The impact of these increased GUD rates on HIV transmission patterns in this population is unknown. METHODS: Sexually transmitted disease (STD) diagnoses were correlated with HIV antibody status and risk factor history in 194 patients who consented to HIV testing at an STD clinic in central Brooklyn. RESULTS: Of 36 HIV-positive patients, 23 (64%) denied HIV risk factors other than heterosexual contact with persons of unknown HIV status. HIV antibody was associated with GUD (odds radio [OR] = 2.72, 95% confidence interval [CI] = 1.20-6.24), multiple concurrent STDs (OR = 2.51, 95% CI = 1.08-5.81), and a history of crack cocaine use (OR = 2.98, 95% CI = inexact-9.61). Crack use was also associated with GUD (OR = 15.15, 95% CI = 3.27-inexact) and multiple simultaneous STDs (OR = 13.87, 95% CI = 4.62-inexact). In a log-linear model analysis, HIV infection was independently associated with GUD and crack use. HIV infection, genital ulcer disease, and crack cocaine use were more common in women than men. CONCLUSIONS: The association between HIV infection and GUD seen here may be secondary to high-risk sexual behavior, which in turn may be partially attributable to crack cocaine use and drug-related prostitution. The high rate of coinfection with HIV and GUD raises a concern about the increased efficiency of sexual transmission of HIV in this population.
Comorbidity↗