Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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 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

        -  1 x 40 mg/kg after enrollment in the study (D1, H0) plus two single doses (40 mg/kg)
           after 12 and 24 hours after the first treatment

        -  1 x 40 mg/kg five weeks following the 1st PZQ treatment

        -  1 x 40 mg/kg ten weeks following the 1st PZQ treatment
    

Intervention name(s): Praziquantel 600Mg Oral Tablet x 5; Praziquantel 600Mg Oral Tablet x 1
Intervention type(s): Drug; Drug
Intervention description(s): Five doses of Praziquantel 40 mg/kg; Single dose of Praziquantel 40 mg/kg
Other intervention name(s): PZQ; PZQ
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schistosomiasis; Praziquantel; Gynaecology; Female