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Biomedical subjects

H H Handsfield

Publications and source records attributed to H H Handsfield.

17 recordsLinked to original sources
PubMed1992

Evaluation of new anti-infective drugs for the treatment of chancroid. Infectious Diseases Society of America and the Food and Drug Administration.

Chancroid is a mucocutaneous infection caused by Haemophilus ducreyi that produces ulcerative lesions and enhances the efficiency of transmission of human immunodeficiency virus (HIV). Confirmation of infection by culture of H. ducreyi is essential in therapeutic trials. Minimal inhibitory concentrations of antibiotics for the isolate should be determined by agar dilution. Patients should be evaluated by appropriate laboratory tests for syphilis, infection with herpes simplex virus, gonorrhea, and (in North America) infection with Chlamydia trachomatis. The clinical history of the disease should be recorded and ulcers, buboes, and lymphadenitis mass described. Whenever possible, study participants also should be tested for HIV infection. Randomized, prospective, double-blind, active-control comparative clinical trials are preferred for evaluation of the safety and efficacy of new anti-infective drugs. Otherwise-healthy men and women should be enrolled in these studies. Patients with active syphilis or genital herpes should be excluded. Microbiological and clinical outcomes are paramount.

Anti-Infective Agents↗
PubMed1992

Evaluation of new anti-infective drugs for the treatment of vaginal infections. Infectious Diseases Society of America and the Food and Drug Administration.

The three major vaginal infections are yeast vulvovaginitis, Trichomonas vaginalis vaginitis, and bacterial vaginosis. In terms of signs and symptoms, these disorders overlap substantially with one another and with other infections. Therefore, the diagnosis of candidiasis and trichomoniasis requires isolation of the responsible pathogen. For the diagnosis of bacterial vaginosis, all other potential causes of vaginal infection must be excluded and specified laboratory criteria must be met. Clinical trials must be carefully designed to control for coexisting pathogens, for potential efficacy of treatment against more than one microbe, and for variable end points used to define clinical response. Prospective, randomized, double-blind, active-control comparative studies are preferred. Follow-up evaluations 5-7 days and 4-6 weeks after the completion of therapy are required for the assessment of outcome. Laboratory studies of vaginal fluid (culture and/or microscopic examination) are paramount in the final appraisal of outcome.

Anti-Infective Agents↗
PubMed1992

Evaluation of new anti-infective drugs for the treatment of uncomplicated gonorrhea in adults and adolescents. Infectious Diseases Society of America and the Food and Drug Administration.

Gonorrhea is among the most common sexually transmitted diseases. Treatment for uncomplicated gonorrhea should be efficacious in > or = 95% of cases. Because patients with gonococcal infections often have other sexually transmitted diseases concurrently, individuals enrolled in clinical trials of therapy for gonorrhea should also be evaluated for infection with Chlamydia trachomatis and for syphilis. Testing for other pathogens should be considered in light of the clinical presentation. The presence of gonococcal infection is defined by a positive culture of a specimen obtained from an appropriate mucosal site. Patients enrolled in clinical trials should be otherwise-healthy adults who agree to return for follow-up assessment. These patients should be stratified by gender and anatomic site of infection. The preferred study design is a prospective, randomized, double-blind, active-control comparison. In some circumstances, however, historical controls may suffice. The study drug must have an efficacy rate of > or = 95% in genital and rectal infections. Microbiological eradication, demonstrated by negative cultures of samples from all potentially infected mucosal sites at follow-up, is the sole determinant of efficacy.

Adolescent↗
PubMed1992

Evaluation of new anti-infective drugs for the treatment of sexually transmitted chlamydial infections and related clinical syndromes. Infectious Diseases Society of America and the Food and Drug Administration.

This guideline addresses clinical trials of new antimicrobial agents in the treatment of uncomplicated genital infections caused by Chlamydia trachomatis and of syndromes resembling chlamydial infections. The most common clinical manifestations of chlamydial infection are urethritis in men and mucopurulent cervicitis in women. However, many chlamydial infections are not associated with inflammatory symptoms or signs. Culture is the diagnostic standard for defining the presence of C. trachomatis, although nonculture tests may be used in screening patients for enrollment in clinical trials. Susceptibility testing for C. trachomatis is laborious and difficult to standardize; only a few clinical isolates need to be tested in vitro. Prospective, randomized, double-blind, active-control comparative studies are recommended. Eradication of C. trachomatis defines both microbiological success and overall cure for chlamydial infection, but clinical and nonmicrobiological laboratory criteria are paramount in assessing the therapeutic response in nonchlamydial urethritis or cervicitis.

Anti-Bacterial Agents↗
PubMed1992

Evaluation of new anti-infective drugs for the treatment of syphilis. Infectious Diseases Society of America and the Food and Drug Administration.

Syphilis is caused by Treponema pallidum, a spirochetal bacterium pathogenic only for humans. The clinical course of disease is divided into three stages interspersed by periods of latency. Penicillin remains the treatment of choice for all stages of infection; tetracycline or erythromycin may be used as therapeutic alternatives in defined circumstances. Patients enrolled in clinical trials should be evaluated clinically, microscopically, and serologically for the presence of the spirochete. All participants, after undergoing counseling and giving informed consent, should be tested for infection with human immunodeficiency virus. Specific criteria exist for diagnosis of syphilis and response to therapy. It may be desirable to perform a small, uncontrolled, open trial of a new anti-infective drug for the collection of preliminary evidence of efficacy. A larger-scale, randomized, active-control comparative clinical trial is necessary to prove efficacy.

Animals↗
PubMed1992

Special issues in clinical trials of new anti-infective drugs for the treatment of sexually transmitted diseases. Infectious Diseases Society of America and the Food and Drug Administration.

Several special issues arise in relation to clinical trials of therapy for sexually transmitted diseases. These issues include the desirability of including adolescents and both pregnant and nonpregnant women in the trial, the use of unapproved control regimens, problems with antimicrobial susceptibility testing due to inadequate methodology and the need for prompt treatment, the need to assess agents for treatment of syndromes of unknown microbial etiology, toxicity considerations related to the use of single-dose regimens, management of the sexual partners of the participants in the trial, analysis of data despite the high frequency of minor protocol violations, sexual reexposure to infection during the trial, and the potential for loss, alteration, or falsification of data because of the relative simplicity of the usual protocol design and the diagnostic reliance on specimens that are routinely discarded.

Adolescent↗
PubMed1992

Evaluation of new anti-infective drugs for the treatment of genital infections due to herpes simplex virus. Infectious Diseases Society of America and the Food and Drug Administration.

This guideline addresses clinical trials of new therapies for genital infections due to herpes simplex virus (HSV). Of the two types of virus, HSV-2 is the more common pathogen. Both HSV-1 and HSV-2 become latent in sacral nerve root ganglia and intermittently reactivate. Patients who have frequent recurrences (more than four per year) may be candidates for long-term suppressive therapy. In both first-episode and recurrent genital HSV infections, lesions should be cultured for HSV. Testing for human immunodeficiency virus is encouraged but not required. Serum antibodies to HSV-1 and HSV-2 should be quantitated at enrollment and 3-5 weeks thereafter. Randomized, double-blind, active-control comparative studies are generally recommended. Placebo-controlled trials may be appropriate for recurrent genital herpes or for suppression of recurrences. Final evaluation should generally take place 10-15 days after the completion of therapy.

Anti-Infective Agents↗
PubMed1992

Alterations in the course of experimental syphilis associated with concurrent simian immunodeficiency virus infection.

Case reports suggest that the course of syphilis is altered in patients infected with human immunodeficiency virus (HIV). To investigate this issue, a model of syphilis in rhesus macaques with and without simian immunodeficiency virus (SIV) was developed. After intradermal inoculation with Treponema pallidum, 2 SIV-infected monkeys had persistent ulcerative primary lesions and 1 developed secondary syphilis. Two SIV-uninfected controls developed transient nonulcerative primary lesions. Only the controls showed consistent VDRL antibody responses. In contrast, reciprocal antibody titers to T. pallidum detected by microhemagglutination were higher in SIV-infected animals (greater than or equal to 20,480) than controls (greater than or equal to 1280). All 4 animals developed a full range of T. pallidum antigen-specific antibodies shown by immunoblot and had similar peak lymphocyte proliferative responses to T. pallidum antigens. These results support the contention that retrovirus-induced immunodeficiency delays clearance of T. pallidum from sites of infection and may impair the humoral immune response to syphilis.

Animals↗
PubMed1979

Nongonococcal urethritis.

The nongonococcal urethritis (NGU) syndrome is a group of sexually transmitted infections that together exceed the frequency of gonorrhea in men in most urban areas of Europe and the United States, and probably in much of the remainder of the world. "Nongonococcal" is preferred to the term "non-specific" urethritis because the latter is less precise and carries the inaccurate implication that the causes are unknown and perhaps unknowable.

Humans↗
PubMed1976

Treatment of the gonococcal arthritis-dermatitis syndrome.

Ninety-eight patients with the gonococcal arthritis-dermatitis syndrome were prospectively treated with penicillin G, at least 10 million units intravenously per day, followed by ampicillin, 2.0 g orally per day, to complete at least 10 days of treatment (33 patients); ampicillin, 3.5 g orally plus probenecid 1.0 g, followed by ampicillin, 2.0 g per day orally for at least 7 days (29 patients); lower doses of parenteral penicillin G (20 patients); oral tetracycline (6 patients); parenteral cephalosporins (5 patients); and other regimens (5 patients). The response to treatment was equally rapid and complete in each group. At least 90% of the patients in each group had subjective improvement and defervescence within 2 days, and all patients followed for at least 2 weeks achieved complete clinical and bacteriologic cure. Patients with purulent synovial effusions improved significantly more slowly than patients with nonpurulent effusions or with no effusions, regardless of which treatment was used.

Administration, Oral↗
PubMed1975

Etiology of nongonococcal urethritis.

Chlamydia trachomatis was isolated from the urethra from 48 (42 per cent) of 113 men with non-gonococcal urethritis (NGU), four (7 per cent) of 58 without overt urethritis, and 13 (19 per cent) of 69 with gonorrhea. Postgonococcal urethritis (PGU) developed in 11 of 11 men who had C. trum antibody to C. trachomatisis developed. The immunotype specificity of chlamydial antibody corresponded to the immunotype isolated. Among culture-negative patients. chlamydial antibody prevalence correlated with the number of past sex partners and with previous NGU. Herpesvirus hominis, cytomegalovirus, T-mycoplasma, Mycoplasma hominis, other bacteria, and Trichomonas vaginalis were not implicated in NGU or PGU. Thus, the cause of chlamydia-negative NGU and PGU remains obscure. Endocervical chlamydia were found in sex partners of 15 of 22 NGU patients with and two of 24 without urethral chlamydial infection (p smaller than 0.001). Tetracycline treatment of both sex partners appears advisable.

Antibodies, Bacterial↗