ABSTRACT
BACKGROUND: C-Tb, an ESAT-6/CFP-10-based skin test, has similar sensitivity for active TB compared to tuberculin skin test (TST) and QuantiFERON-TB-Gold-In-Tube (QFT). However, data are limited in children and HIV-infected persons. METHODS: Asymptomatic South African contacts <5 years (n = 87; HIV-uninfected), or symptomatic individuals of all ages presenting to clinics with suspected TB (n = 1003; 30% HIV-infected) were recruited from eight South African centres. C-Tb and TST were allocated to either forearm double blinded. Samples for QFT were collected in parallel, and test-positivity rates were compared. RESULTS: In participants with microbiologically confirmed TB (n = 75; 45% HIV-infected) sensitivity of C-Tb, TST and QFT were similar (72% versus 75% versus 73%; p>0.5). All 3 tests had similar positivity rates in HIV-infected participants with active TB, however, positivity rates were reduced when CD4 counts were <100 cells/µL. In participants where active TB was excluded (n = 920), C-Tb (41%), TST (43%), and QFT (44%) also had similar test-positivity rates. Among asymptomatic contacts aged below five, 32% (28/87) tested positive with C-Tb and 32% (28/87) with TST (concordance 89%). Overall, C-Tb and TST showed a similar safety profile. CONCLUSION: C-Tb was safe and showed similar test-positivity rates, compared to TST and QFT, in children and HIV-infected persons with active or latent M. tuberculosis infection. These data inform the utility of C-Tb in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT01642888. EudraCT 2011-005078-40.
Subject(s)
Coinfection/diagnosis , HIV Infections/complications , Skin Tests/methods , Tuberculosis/complications , Tuberculosis/diagnosis , Adolescent , Adult , Aged , Child , Child, Preschool , Double-Blind Method , Female , HIV Infections/diagnosis , Humans , Infant , Infant, Newborn , Male , Middle Aged , Sensitivity and Specificity , Young AdultABSTRACT
AIM: We compared the efficacy and safety of ozenoxacin (a new nonfluorinated quinolone) 1% cream with placebo in the treatment of impetigo. PATIENTS & METHODS: In a randomized, double-blind, multicenter study, patients received ozenoxacin cream or placebo cream twice daily for 5 days (a third group received retapamulin 1% ointment as a control). Clinical, microbiological and laboratory evaluations were performed during follow-up (over 2 weeks). RESULTS: Ozenoxacin was superior to placebo (success rate 34.8 vs 19.2%; p = 0.003). Microbiological success was 70.8% for ozenoxacin and 38.2% for placebo after 3-4 days and 79.2% versus 56.6% after 6-7 days. Ozenoxacin produced more rapid microbiological clearance than retapamulin. All treatments were well tolerated. CONCLUSION: Ozenoxacin 1% cream was effective and safe in the treatment of impetigo.
Subject(s)
Aminopyridines/therapeutic use , Anti-Bacterial Agents/therapeutic use , Bridged Bicyclo Compounds, Heterocyclic/therapeutic use , Impetigo/drug therapy , Quinolones/therapeutic use , Adolescent , Child , Child, Preschool , Diterpenes , Dose-Response Relationship, Drug , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , OintmentsABSTRACT
BACKGROUND: There are no known racial differences in genital herpes disease pathogenesis or response to therapy. Despite high herpes simplex virus (HSV) seroprevalence in Black persons, clinical trials investigating the treatment of recurrent genital herpes (RGH) have typically enrolled a small proportion of Black patients. METHODS: This multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of patient-initiated, 1-day famciclovir 1000 mg twice-daily in immunocompetent Black adults (USA and South Africa) with RGH. Eligible patients were randomized (2:1) to famciclovir or placebo. The primary endpoint was time to healing of non-aborted genital herpes lesions (i.e., lesions that progressed beyond papule stage). Secondary endpoints included proportion of patients with aborted genital herpes lesions, time to resolution of associated symptoms, and safety. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov ; trial identifier NCT00477334. RESULTS: A total of 299 patients with RGH (66% female, median age = 37 years) received either 1-day famciclovir 1000 mg twice-daily (n = 201) or placebo (n = 98). In the modified intent-to-treat population, the estimated median time to healing of non-aborted genital herpes lesions was 5.38 days for famciclovir and 4.79 days for placebo (median of treatment differences = 0.26 days; 95% CI [-0.40, 0.98]; p = 0.416). Consistent findings were reported in the completer and per-protocol populations. No significant differences were reported for all secondary analyses. Adverse events (AEs) were consistent with the established safety profile of famciclovir: 18 (6%) patients had drug-related AEs (16 [8%] famciclovir; 2 [2%] placebo), none of which were serious or led to discontinuation or dose adjustment/interruption. There are some limitations of this research: many study sites either lacked prior experience in conducting clinical studies in patients with HSV infection or enrolled small numbers of patients, which may have compromised efficacy outcomes. Also, HIV antibody testing was not mandated at enrollment. CONCLUSION: This study showed similar efficacy and tolerability of 1-day treatment with famciclovir 1000 mg twice-daily compared to placebo in immunocompetent Black adults with RGH. Famciclovir has proven efficacy and safety in the overall RGH population. Further understanding of the efficacy of antiherpes therapy in Black patients with recurrent genital herpes may be warranted.
