Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in Subjects With Schistosomiasis: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Peak percentage change from baseline eosinophil count
研究概览
简要总结
Background:
Schistosomiasis is a chronic infection. It is caused by parasitic worms called Schistosoma haematobium (Sh) that are spread by snails that live in rivers. It can lead to liver problems or bladder cancer. Praziquantel (PZQ) is a drug used to treat this infection. After taking it, some people develop increased resistance to reinfection with Sh. Some people with Sh infection can be infected with another worm called Mansonella perstans (Mp). Mp is spread through a biting insect called a midge. It rarely causes symptoms. However, researchers think that Mp infection could affect the body s response to PZQ treatment for or risk of reinfection with Sh.
Objective:
To find out the effects of Mp infection on the response to PZQ treatment for Sh infection.
Eligibility:
Men and women ages 14-80 who:
- Live in Tieneguebougou, Bougoudiana, or surrounding villages in Mali
- Are not pregnant
- Have Sh infection
- Have no other chronic medical conditions
Design:
-
Participants will be screened with:
-
Medical history
-
Physical exam
-
Blood and urine tests
-
Stool samples
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Participants will be treated with a single dose of PZQ by mouth.
-
After receiving PZQ, participants will return to the clinic for blood and urine tests at the following times:
-
4, 8, 24, 48, and 72 hours later
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5, 7, 9, and 14 days later
-
1, 3, and 6 months later
Participants who are infected with Sh at the 6-month visit will get another treatment with PZQ.
...
详细描述
Chronic filarial infection is associated with downregulation of immune responses to both helminth and non-helminth antigens. Praziquantel (PZQ) treatment of schistosomiasis is associated with a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia that is correlated with resistance to reinfection. We hypothesize that chronic filarial infection with Mansonella perstans (Mp) may attenuate post-treatment eosinophilia and thus impact resistance to reinfection. To address the first part of this question, we plan to compare post-PZQ reactions and reinfection rates in 20 subjects with schistosomiasis and Mp infection to those in 20 subjects with schistosomiasis and no evidence of filarial infection in an area coendemic for both infections in Mali. Signs and symptoms, complete blood counts, intracellular and serum cytokine levels, and markers of eosinophil activation will be assessed at baseline, 4 and 8 hours, and 1, 2, 3, 5, 7, 9, and 14 days post-treatment and compared between the two treatment groups. Schistosoma haematobium reinfection rates will also be compared at 1, 3, and 6 months post-treatment.
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
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sh
Mono infected with Schistosoma haematobium
干预措施: Praziquantel (Drug)
ShMp
Coinfected with Schistosoma haematobium andMansonella perstans
干预措施: Praziquantel (Drug)
结局指标
主要结局
Peak percentage change from baseline eosinophil count
时间窗: During the first 7 days post-treatment
次要结局
- Frequency and severity of adverse events(During the first 3 days post-treatment)
- Number of subjects with detectable Sh eggs in urine(At 1, 3 and 6 months post-treatment)
- Peak absolute change from the baseline eosinophil count and peakpercentage change in eosinophil granule protein levels(During the first 7 days post-treatment)