Schistosomiasis Clinical Trial
Official title:
Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
Verified date | May 2020 |
Source | Vendsyssel Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | February 21, 2020 |
Est. primary completion date | February 21, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Madagascar | K'Olo Vanona | Ambanja | Diana |
Lead Sponsor | Collaborator |
---|---|
Vendsyssel Hospital | Charite University, Berlin, Germany, Leiden University Medical Center, Merck Serono International SA, Ministry of Health, Madagascar, Nagasaki University, Umeå University |
Madagascar,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathognomonic sign(s) in the cervix | Changes is quantitatively measured by the comparison of the number of sectors of the cervix affected by a pathognomonic sign before treatment and at the end of the study. | 15 weeks | |
Secondary | Gynaecological complaint score | Gynaecologial symptoms assessed by a questionnaire (Lower abdominal pain, Itching of vagina/vulva, Vaginal discharge with a strange odor, Pain/abnormal sensation during sexual intercourse, Bleeding after sexual intercourse, Abnormal sensation when touching vulva/vagina, Spontaneous bleeding (outside menstruation), Irregular menstruation, Infertility (primary or secondary) after two years without contraception, Pain during micturition, Blood in urine outside menstruation). | 15 weeks | |
Secondary | Vaginal Schistosome DNA | Concentration of schistosome DNA in vaginal fluid | 15 weeks | |
Secondary | Vaginal Pro-inflammatory Th2-dependent cytokines /chemokines | Concentration of selected pro-inflammatory Th2-dependent cytokines /chemokines in vaginal fluid | 15 weeks | |
Secondary | Vaginal ECP | Eosinophilic cationic protein (ECP) in vaginal lavage fluid | 15 weeks | |
Secondary | Cytobrush Schistosome DNA | Concentration of schistosome DNA in cytobrush material from vagina | 15 weeks |
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