Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04115072
Status:
COMPLETED
Last Update Posted:
2020-05-18
First Post:
2019-08-22
Brief Title:
Treatment of Female Genital Schistosomiasis FGS With Praziquantel A Proof-of-Concept Study
Sponsor:
Vendsyssel Hospital
Organization:
Vendsyssel Hospital
Study Overview
Official Title:
Treatment of Female Genital Schistosomiasis FGS With Praziquantel A Proof-of-Concept Study
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 disappearanceregression of clinical pathology at the cervix in the vaginavulva
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 disappearanceregression of clinical pathology at the cervix in the vaginavulva
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 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 disappearanceregression of clinical pathology at the cervix in the vaginavulva
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 mgkg- with a treatment based on a new rationale five doses of praziquantel 40 mgkg
1 x 40 mgkg after enrollment in the study D1 H0 plus two single doses 40 mgkg after 12 and 24 hours after the first treatment
1 x 40 mgkg five weeks following the 1st PZQ treatment
1 x 40 mgkg ten weeks following the 1st PZQ treatment
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 disappearanceregression of clinical pathology at the cervix in the vaginavulva
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 mgkg- with a treatment based on a new rationale five doses of praziquantel 40 mgkg
1 x 40 mgkg after enrollment in the study D1 H0 plus two single doses 40 mgkg after 12 and 24 hours after the first treatment
1 x 40 mgkg five weeks following the 1st PZQ treatment
1 x 40 mgkg ten weeks following the 1st PZQ treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None