Prevention of Female Genital Schistosomiasis (FGS) in Rural High-endemic South Africa

NCT01154907 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 6500

Last updated 2017-09-19

No results posted yet for this study

Summary

Schistosomiasis is a poverty-related water-transmitted parasitic disease affecting more that 200 million people world wide. Infection with Schistosoma haematobium may cause Female Genital Schistosomiasis (FGS) with pathological lesions in the female genital tract, especially the cervix. Findings indicate that FGS is a hitherto under-diagnosed illness of young women in endemic poor tropical countries, deserving further attention. A cross-sectional study from Zimbabwe indicated that the pathologic genital lesions were unchanged two years after praziquantel treatment in adult women whereas in those who had been treated with praziquantel in childhood the prevalence of genital lesions was significantly lower. Furthermore, a higher prevalence of HIV was detected in women with FGS compared to those without. The proposed project aims at achieving a better understanding of how annual distribution of praziquantel to pre- and post-pubertal schoolgirls may prevent FGS. This information can be of use in current schistosomiasis control programs in the near term resulting in improved strategies for treatment. Preventing or reducing the risk of FGS and genital lesions will lead to improved reproductive health among in women living in schistosomiasis endemic areas.

Project Goal: Contribute to a reduction of the global burden of female genital schistosomiasis (FGS) through improved knowledge about the prevention of gynecological lesions and through improved diagnosis of FGS.

Conditions

  • Uro-genital Schistosomiasis

Interventions

DRUG

Praziquantel

One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities

Sponsors & Collaborators

  • University of KwaZulu

    collaborator OTHER
  • University of Agder

    collaborator OTHER
  • Sorlandet Hospital HF

    collaborator OTHER_GOV
  • University of Copenhagen

    collaborator OTHER
  • Leiden University Medical Center

    collaborator OTHER
  • Universiteit Antwerpen

    collaborator OTHER
  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Eyrun F Kjetland, MD, PhD · Oslo University Hospital, University of KwaZulu-Natal (UKZN)

  • Myra Taylor, PhD · UKZN/ Child Development Research Unit (CDRU)

  • Jane Kvalsvig, PhD · UKZN/ CDRU

  • Svein G Gundersen, MD, PhD · Agder University Hospital / Sorlandet Hospital

Eligibility

Min Age
10 Years
Max Age
23 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2018-12-31
Completion
2021-12-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01154907 on ClinicalTrials.gov