In an exploration of the natural history of post-kala-azar dermal leishmaniasis (PKDL), 134 residents of Sudan who had recently been diagnosed as cases of the disease were investigated. In each case, diagnosis had been based on clinical criteria, the temporal relationship between the rash and the treatment of visceral leishmaniasis (VL), positive results in direct agglutination tests (DAT) and/or leishmanin skin tests (LST), and the exclusion of other skin conditions. The mean (S.D.) age of the subjects was 6.4 (3.0) years. Although PKDL appeared commonest among those aged 4-8 years (P < 0.05), it was most severe in children aged
Post-kala-azar dermal leishmaniasis (PKDL) is a chronic, stigmatizing skin condition occurring frequently after apparent clinical cure from visceral leishmaniasis. Given an urgent need for new treatments, we conducted a phase IIa safety and immunogenicity trial of ChAd63-KH vaccine in Sudanese patients with persistent PKDL. LEISH2a (ClinicalTrials.gov: NCT02894008) was an open-label three-phase clinical trial involving sixteen adult and eight adolescent patients with persistent PKDL (median duration, 30 months; range, 6-180 months). Patients received a single intramuscular vaccination of 1 Â 10 10 viral particles (v.p.; adults only) or 7.5 Â 10 10 v.p. (adults and adolescents), with primary (safety) and secondary (clinical response and immunogenicity) endpoints evaluated over 42-120 days follow-up. AmBisome was provided to patients with significant remaining disease at their last visit. ChAd63-KH vaccine showed minimal adverse reactions in PKDL patients and induced potent innate and cell-mediated immune responses measured by whole-blood transcriptomics and ELISpot. 7/23 patients (30.4%) monitored to study completion showed >90% clinical improvement, and 5/23 (21.7%) showed partial improvement. A logistic regression model applied to blood transcriptomic data identified immune modules predictive of patients with >90% clinical improvement. A randomized controlled trial to determine whether these clinical responses were vaccine-related and whether ChAd63-KH vaccine has clinical utility is underway.
Purpose. The aim of this study was to find out the correlation between magnetic resonance imaging (MRI) and nerve conduction studies’ (NCS) findings in patients with lumbosacral radiculopathy caused by lumbar intervertebral disc herniation. In addition, the study aimed at finding the correlation between the clinical manifestations of lumbosacral radiculopathy and both MRI and NCS. Patients and Methods. The study was a cross-sectional analytic study which included thirty patients with a history suggestive of lumbosacral radiculopathy. Inclusion criteria were as follows: patients who had an MRI confirmed L4/5 and/or L5/S1 intervertebral disc prolapse in addition to one or more of the following (dermatomal distribution of symptoms appropriate with MRI level, presence of motor weakness, sensory impairment, absent ankle jerk, or positive straight leg raising test). All patients underwent clinical assessment and NCS, and their MRI examination was reviewed. The Chi-Squared/Fisher’s exact test was used to test the correlation. Results. There was a statistically significant correlation between abnormal physical findings and nerve root compression in MRI. Statistically significant correlation was neither found between abnormal physical examination findings and abnormal NCS nor between nerve root compression in MRI and abnormal NCS findings. Conclusion. Abnormal neurological examination findings can be used to predict nerve root compression in MRI examination. On the contrary, positive findings of physical examination do not predict abnormal NCS, as well as negative findings do not exclude abnormal NCS; therefore, it is useful to add NCS when MRI findings do not match clinical examination findings or when no neuroimaging abnormalities can be identified.
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