A Phase 2/3 interventional study of Praziquantel 600Mg Oral Tablet x 5 and Praziquantel 600Mg Oral Tablet x 1 in Schistosomiasis, sponsored by Regionshospital Nordjylland. Completed at 1 site in Madagascar. Open to female participants aged 15 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-18.
Sponsored by Regionshospital Nordjylland · Phase 2/3, Interventional, and Treatment
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.
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 with important, frequently debilitating and stigmatizing morbidity. It may develop into a life-threatening condition. FGS is probably the most neglected gynaecological condition in the tropics.
Depending on where eggs are released the clinical pathology develops in vulva and vagina, cervix, uterus, Fallopian tubes and the ovaries. All genital organs may be affected simultaneously. Women with FGS report spontaneous, or post-coital bleeding, vaginal discharge, pain during sexual intercourse, pelvic pain, irregular menstruation and infertility. Vaginal discharge and itching, pain during sexual intercourse, spontaneous + post-coital bleeding, as well as menstruation abnormalities are attributed by the women to STIs. This results in shame, mental strain and distress, eventually causes stigmatization and social exclusion leading to an impaired life quality.
Clinical, histopathological, immunological and epidemiological evidence suggests that there is a cause-effect relationship between FGS and HIV infection. There are hints of a cause effect relationship between FGS and HPV. The association of FGS with HIV /HPV infection underlines the pivotal importance for an effective treatment of FGS.
Clinical pathology is the result of a complex inflammatory response to antigens released by adult worms and viable eggs. The inflammation of genital tissue persists as long as adult worms are present in the circulation, and new eggs are released and become trapped. Hence, lesions can only heal if the inflammation is abated and a normal immune response is restored. This means that all worms have to be eliminated and reinfection has to be prevented for some time to allow complete healing of genital organs.
Based on this rationale, five doses of praziquantel will be given over a period of 10 weeks to ensure that all existing worms will be eliminated. The first three doses aim to kill all adult worms. The fourth dose will kill schistosomula which will mature in the following weeks. The last dose will prevent women from re-infection.
A randomized controlled study will be carried out to compare the efficacy of the standard treatment with that of repeated doses of praziquantel. Since a placebo is not available, the study will not be blinded. Outcome measure is the disappearance/regression of clinical pathology at the cervix, in the vagina/vulva.
The result of this study has important implications for the sexual health of millions of women in sub-Saharan Africa.
The aim of the study is to compare standard treatment of schistosomiasis as recommended by WHO (a single dose of praziquantel 40 mg/kg)- with a treatment based on a new rationale: five doses of praziquantel 40 mg/kg
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's enrollment of 116 is below the median of 289 across 52 interventional studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →Regionshospital Nordjylland is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Single dose of Praziquantel 40 mg/kg Standard treatment of schistosomiasis as recommended by WHO
Drug: Praziquantel 600Mg Oral Tablet x 1
Five doses of Praziquantel 1 x 40 mg/kg Praziquantel after enrollment in the study plus two single doses (40 mg/kg) after 12 and 24 hours after the first treatment 1 x 40 mg/kg Praziquantel five weeks following the 1st dose 1 x 40 mg/kg Praziquantel ten weeks following the 1st dose
Drug: Praziquantel 600Mg Oral Tablet x 5
Five doses of Praziquantel 40 mg/kg
Also known as: PZQ
Single dose of Praziquantel 40 mg/kg
Also known as: PZQ
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.
Time frame: 15 weeks
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).
Time frame: 15 weeks
Vaginal Schistosome DNA
Concentration of schistosome DNA in vaginal fluid
Time frame: 15 weeks
Vaginal Pro-inflammatory Th2-dependent cytokines /chemokines
Concentration of selected pro-inflammatory Th2-dependent cytokines /chemokines in vaginal fluid
Time frame: 15 weeks
Vaginal ECP
Eosinophilic cationic protein (ECP) in vaginal lavage fluid
Time frame: 15 weeks
Cytobrush Schistosome DNA
Concentration of schistosome DNA in cytobrush material from vagina
Time frame: 15 weeks
Plan to share: No
Ran from Sep 2019 to primary completion in Feb 2020, 5 months.
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Studies of the drug tested here: Praziquantel
Regionshospital Nordjylland