Status:
COMPLETED
Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
Lead Sponsor:
Regionshospital Nordjylland
Collaborating Sponsors:
Charite University, Berlin, Germany
Leiden University Medical Center
Conditions:
Schistosomiasis
Eligibility:
FEMALE
15-35 years
Phase:
PHASE2
PHASE3
Brief Summary
Female genital schistosomiasis (FGS) is a frequent manifestation of the infection with Schistosoma haematobium or mansoni. FGS is probably the most neglected gynaecological condition in the tropics. ...
Detailed Description
Female genital schistosomiasis (FGS) is a frequent manifestation of the infection with Schistosoma haematobium or mansoni. It occurs in women of all age groups, including young girls and is associated...
Eligibility Criteria
Inclusion
- Women 15 to 35 years of age with a gynaecological/urinary/lower abdominal complaint
- The woman has signed the informed consent form (IFC); in the case of minors, the IFC has to be signed by parent or guardian.
- The woman does not plan to leave the area within 6 months and accept to come to the CSB regularly following the scheduled follow-up (at week 5,10 and 15).
- The woman with confirmed diagnosed of FGS (as described in section 6.3.1)
- The woman agrees to be examined clinically and gynaecologically including taking specimens from the genital tract (collection of vaginal lavage fluid, collection of cells with a cytobrush).
- The woman agrees to provide a urine and a stool sample.
- The woman agrees that a venous blood sample for laboratory assessments is taken.
- The woman accepts to stay at the hospital for 2 days follow-up after the first dose of PZQ.
Exclusion
- Virgin (assessed by gynaecologist)
- Pregnancy (determined by pregnancy test)
- Tumor of vulva, vagina, uterus (diagnosed by gynaecologist)
- Treatment with praziquantel during the last 3 months
- Hysterectomy
- Known HIV positive prior to enrollment
- Any severe medical condition requiring hospitalization
- The woman is unable to comprehend the nature and objectives of the study
- The woman is judged by the investigators to be unlikely to participate regularly in the follow-up
- The woman is taking any drug that might affect the metabolism of PZQ and that is contraindicated the last two weeks before the enrollment. These drugs are as follows: rifampin; phenytoin, carbamazepine, phenobarbital; dexamethasone;
- The woman is taking a drug which decreases the activity of praziquantel metabolizing enzymes (P450 inhibitors) the last two weeks before the enrollment, for example cimetidine, ketoconazole, itraconazole, erythromycin.
- All contraindications to Praziquantel
Key Trial Info
Start Date :
September 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2020
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04115072
Start Date
September 3 2019
End Date
February 21 2020
Last Update
May 18 2020
Active Locations (1)
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1
K'Olo Vanona
Ambanja, Diana Region, Madagascar, 203