Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study

• Status: Completed
• Trial end date: 2020-02-21
• Target enrollment: 0
• Participant gender: Female

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.

Inflammation of genital tissue persists as long as adult worms are present in the circulation, and new eggs are released. Hence, lesions can only heal if the inflammation is abated and a normal immune response is restored

A randomized controlled study will be carried out to compare the efficacy of the standard treatment with that of five repeated doses of praziquantel.

Outcome measure is the disappearance/regression of clinical pathology at the cervix, in the vagina/vulva.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vendsyssel Hospital
• Collaborators: Charite University, Berlin, Germany; Leiden University Medical Center; Merck Serono International SA; Ministry of Health, Madagascar; Nagasaki University; Umeå University
• Treatments: Praziquantel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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