Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment

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Brief Title

Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment

Official Title

Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment

Brief Summary

      Objective and Hypotheses: This project has the overall objective of implementing and
      evaluating new approaches to reducing the current and future burden of urinary
      schistosomiasis in young children using the antihelminthic drug Praziquantel. The project
      aims to (1) determine the operational health benefits of treating schistosome infections
      early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome
      structure (species diversity or abundance) is a risk factor for S. haematobium infection or
      morbidity, and (3) elucidate the factors and underlying mechanisms mediating the
      reduction/reversal of schistosome-related morbidity and resistance against
      infection/re-infection in young children.
    

Detailed Description

      This study aims to refine current paediatric treatment of schistosomiasis using the drug
      Praziquantel (PZQ) to improve the current and future health of pre-school children and
      infants. Praziquantel is cheap, highly efficacious and safe, presenting a realistic
      opportunity of using a pre-existing tool in a modified way to benefit child health and
      development. The study will focus on children aged 3 to 5 years of age, comparing the impact
      of early vs. later treatment with PZQ on the current and future health status of the
      children. By killing worms PZQ stops the morbidity related to the presence of worms and eggs
      such as anaemia, abdominal pain, diarrhoea and blood in the urine as well as induced immune
      responses associated with reduced re-infection rates. Therefore the study will investigate
      the immediate health benefits of treating pre-school children and infants and the effects of
      treatment on re-infection rates.
    


Study Type

Observational


Primary Outcome

Re-infection rates in children treated upon first infection compared to re-infection rates in children treated within 12 months of infection.

Secondary Outcome

 Change in immune measures (cytokine and antibody levels) following curative treatment

Condition

Schistosomiasis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

700

Start Date

February 2016

Completion Date

February 27, 2018

Primary Completion Date

January 2018

Eligibility Criteria

        Inclusion Criteria:

          1. lifelong residents of the area

          2. have provided at least 2 urine and 2 stool for parasitological examination

          3. have given a blood sample before and after each treatment episode

          4. be negative for schistosomes, hookworm, Trichuris and Ascaris

          5. have frequent contact with infective water

        Exclusion Criteria:

          1. clinical signs of tuberculosis or malaria

          2. presenting with fever

          3. have had a recent major operation, illness or vaccination

          4. have previously received antihelminthic treatment

          5. are infected with any helminths
      

Gender

All

Ages

3 Years - 5 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Francisca Mutapi, PhD, , 

Location Countries

Zimbabwe

Location Countries

Zimbabwe

Administrative Informations


NCT ID

NCT02495909

Organization ID

MRCZ/A/1964


Responsible Party

Sponsor

Study Sponsor

University of Edinburgh

Collaborators

 University of Zimbabwe

Study Sponsor

Francisca Mutapi, PhD, Principal Investigator, University of Edinburgh


Verification Date

October 2018