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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02755324
Other study ID # CoHSI1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 27, 2016
Est. completion date January 21, 2019

Study information

Verified date November 2020
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Groups of 3 or 7 volunteers will be exposed to a predetermined number of male Schistosoma mansoni cercariae until 10 volunteers are found infected.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date January 21, 2019
Est. primary completion date July 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Subject is aged = 18 and = 45 years and in good health. 2. Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby. 3. Subject is able to communicate well with the investigator, is available to attend all study visits. 4. Subject will remain within Europe (excluding Corsica) during the study period and is reachable by mobile telephone from week 3 to week 12 of the study period. 5. Subject agrees to refrain from blood donation throughout the study period. 6. For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study. 7. Subject has signed informed consent. Exclusion Criteria: 1. Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immune-deficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following: - body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening; - positive HIV, hepatitis B or hepatitis C screening tests; - the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period; - history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years; - any history of treatment for severe psychiatric disease by a psychiatrist in the past year; - history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset. - Any clinically significant abnormalities (including extended QT interval) on electrocardiogram 2. The chronic use of any drug known to interact with praziquantel, or artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidon, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class I and III anti-arrythmics, antipsychotics, antidepressants, macrolides, fluoroquinolones, imidazole- and triazole antimycotics, antihistamines) Because lumefantrine may cause extension of QT-time, chronic use of drugs with effect on QT interval are excluded from the study. 3. For female subjects: positive urine pregnancy test at screening. 4. Any history of schistosomiasis or treatment for schistosomiasis. 5. Positive serology for schistosomiasis or elevated serum or urine circulating anodic antigen or positive Schistosoma serology at baseline. 6. Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel or, artesunate or lumefantrine. 7. Being an employee or student of the department of parasitology or infectious diseases of the Leiden University Medical Center.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
male Schistosoma mansoni cercariae
Viable male Schistosoma mansoni cercariae of the Puerto Rican strain

Locations

Country Name City State
Netherlands Leiden University Medical Center Leiden

Sponsors (1)

Lead Sponsor Collaborator
Leiden University

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Langenberg MCC, Hoogerwerf MA, Janse JJ, van Lieshout L, Corstjens PLAM, Roestenberg M; CoHSI clinical trial team. Katayama Syndrome Without Schistosoma mansoni Eggs. Ann Intern Med. 2019 May 21;170(10):732-733. doi: 10.7326/L18-0438. Epub 2019 Jan 8. — View Citation

Langenberg MCC, Hoogerwerf MA, Koopman JPR, Janse JJ, Kos-van Oosterhoud J, Feijt C, Jochems SP, de Dood CJ, van Schuijlenburg R, Ozir-Fazalalikhan A, Manurung MD, Sartono E, van der Beek MT, Winkel BMF, Verbeek-Menken PH, Stam KA, van Leeuwen FWB, Meij P — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of grade 3 and 4 adverse events, possibly, probably or definitely related to controlled human Schistosoma mansoni infection with male cercariae. 20 weeks
Primary The number of male cercariae at which 100% volunteers show detectable Schistosoma mansoni circulating anodic antigen (CAA). 12 weeks
Secondary Average number of weeks until positive serum circulating anodic antigen test 12 weeks
Secondary Comparison of the height of the peak serum circulating anodic antigen concentration in low dose compared with high dose group 12 weeks
Secondary Comparison of the humoral (antibody) response profile by protein and glycan array between infected and uninfected individuals 1 year
Secondary Differences in in ex vivo lymphocyte profiles between infected and uninfected individuals 1 year
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