Filling Key Research Gaps With Clinical Implications in Mansonellosis and Schistosomiasis: a Network Approach
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Percentage of M. perstans microfilariae
研究概览
简要总结
This is an experimental, multicenter, non-profit study promoted by the Department of Infectious and Tropical Diseases of the IRCCS (Istituto di Ricerca e Cura a carattere scientifico) Sacro Cuore Don Calabria of Negrar which aims to evaluate the presence of endosymbiont Wolbachia in circulating microfilariae obtained from biological samples of individuals infected with M .perstans and the presence of infection with hybrid Schistosoma species in the population of Schistosoma eggs isolated from biological samples of patients with active schistosomiasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •samples from patients who gave consent to the storage and use for research purposes of their samples. In the case a network centre necessitates a template for the storage and use for research purposes of their samples;
- •samples collected before any treatment with praziquantel and/or benzimidazole and/or avermectin and/or diethylcarbamazine and/or doxycycline drug;
- •samples collected and stored in conditions suitable for this study (Annex 2);
- •known country of birth of the patient or of most likely infection (if different from the country of birth)
排除标准
- •- no compliance with at least one of the above-mentioned inclusion criteria.
研究组 & 干预措施
Biological samples
M. perstans microfilariae and Schistosoma spp eggs, obtained from the routine diagnostic procedures carried out on patients, specifically migrants and travellers, visited in the centres participating to this study
干预措施: Molecular biology analyses (Diagnostic Test)
结局指标
主要结局
Percentage of M. perstans microfilariae
时间窗: Baseline
Percentage of samples, defined as the whole M. perstans microfilariae retrieved from one blood sample from each patient, positive for the presence of Wolbachia as assessed by PCR.
Number of Schistosoma eggs
时间窗: Baseline
Number of samples defined as the whole Schistosoma eggs retrieved from one stool or urine sample from each patient, positive for the presence Schistosoma hybrid species.
Percentage of Schistosoma eggs
时间窗: Baseline
Percentage of samples defined as the whole Schistosoma eggs retrieved from one stool or urine sample from each patient, positive for the presence Schistosoma hybrid species.
Number of M. perstans microfilariae
时间窗: Baseline
Number of samples, defined as the whole M. perstans microfilariae retrieved from one blood sample from each patient, positive for the presence of Wolbachia as assessed by PCR.
次要结局
- Identification of hybrid species of Schistosoma spp.(Baseline)
- Percentage of samples positive for Wolbachia(Baseline)
- Number of samples positive for Wolbachia(Baseline)
- Number of samples positive for Schistosoma hybrid species(Baseline)
- Percentage of samples positive for Schistosoma hybrid species(Baseline)