A Phase 4 interventional study of Praziquantel in Schistosomiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Withdrawn. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 4, Interventional, and Basic science
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:
Design:
Participants will be screened with:
After receiving PZQ, participants will return to the clinic for blood and urine tests at the following times:
Participants who are infected with Sh at the 6-month visit will get another treatment with PZQ.
...
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.
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
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INCLUSION CRITERIA (SCREENING):
EXCLUSION CRITERIA (SCREENING):
INCLUSION CRITERIA (INTERVENTIONAL STUDY):
EXCLUSION CRITERIA (INTERVENTIONAL STUDY):
EXCLUSION OF CHILDREN AND PREGNANT WOMEN:
Pregnant women will be excluded from this study since it involves administration of medications in pregnancy. Children less than 14 years old will be excluded because of the amount of blood required for the immunologic studies. The age of consent in Mali is 18 years of age, so children aged 14 to 17 years will sign an assent form in addition to the consent form to be signed by a parent or tutor. However, married women between the ages of 14 and 17 will sign consent as adults in view of the laws governing emancipation of women in Mali. Subjects who do not participate in this study will receive PZQ as part of the national schistosomiasis control program.
Participation of Women:
-Pregnancy: The effects of praziquantel on the developing human fetus are unknown (pregnancy category B). For this reason, females of
childbearing-age must have a negative pregnancy test result prior to receiving praziquantel. Since the half-life of praziquantel is short (3-4 hours), measures will not be required post-treatment.
-Breast feeding: Praziquantel is known to be present in breast milk for up to 3 days following a single dose and is not approved for use in children under the age of 4 years. Consequently, women will be asked to suspend breastfeeding after treatment with PZQ for 3 days. Formula will be provided for breastfed children affected by their mother s participation during this time to ensure adequate nutrition. Depending on the age of the child, formula may be given. A pediatric nurse will be present during this time to provide assistance and counsel to the mothers.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mono infected with Schistosoma haematobium
Drug: Praziquantel
Coinfected with Schistosoma haematobium andMansonella perstans
Drug: Praziquantel
Anthelminthic
Peak percentage change from baseline eosinophil count
Time frame: During the first 7 days post-treatment
Peak absolute change from the baseline eosinophil count and peakpercentage change in eosinophil granule protein levels
Time frame: During the first 7 days post-treatment
Frequency and severity of adverse events
Time frame: During the first 3 days post-treatment
Number of subjects with detectable Sh eggs in urine
Time frame: At 1, 3 and 6 months post-treatment
No study locations are listed for this record.
This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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