WithdrawnPhase 4

Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in People With Schistosomiasis

0Started 2016-04-06

Plain-language summary

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 * 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 * 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. ...

Who can participate

Age range

14 Years – 80 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or non-pregnant female subjects
. Age 14-80 years (per participant self-report)
. Resident of Tienegubougou, Bougoudiana or surrounding villages

Exclusion criteria

. Known to be pregnant (by history)
. Chronic medical conditions, including but not limited to diabetes, renal or hepatic insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the investigators judgments are deemed to be clinically significant
. History of hypersensitivity reaction to PZQ.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peak percentage change from baseline eosinophil count

Timeframe: During the first 7 days post-treatment

Trial details

NCT IDNCT02734186

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2018-12-14

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