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

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.

Conditions

• Schistosomiasis

Interventions

DRUG

Praziquantel 600Mg Oral Tablet x 5

Five doses of Praziquantel 40 mg/kg

DRUG

Praziquantel 600Mg Oral Tablet x 1

Single dose of Praziquantel 40 mg/kg

Sponsors & Collaborators

• Charite University, Berlin, Germany

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Nagasaki University

  collaborator OTHER

• Umeå University

  collaborator OTHER

• Merck Serono International SA

  collaborator INDUSTRY

• Ministry of Health, Madagascar

  collaborator OTHER_GOV

• Regionshospital Nordjylland

  lead OTHER_GOV

Principal Investigators

• Peter Leutscher, PhD · Centre for Clinical Research, North Denmark Regional Hospital, Denmark

• Bodo S Randrianasolo, MD · K'OLO VANONA; Antananarivo, Madagascar

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-03

Primary Completion

2020-02-21

Completion

2020-02-21

Countries

• Madagascar

Study Locations