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Schistosoma Mansoni in Mwanza Region, Tanzania (SCORE_PAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162875
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Pascal Magnussen, DBL -Institute for Health Research and Development

Brief Summary:
The objective of this study is to determine the strategy for mass drug administration (MDA) which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in school-aged children after 4 years of intervention.

Condition or disease Intervention/treatment Phase
Schistosoma Mansoni Drug: Praziquantel Not Applicable

Detailed Description:
Intestinal schistosomiasis is caused by the blood-dwelling flatworm Schistosoma mansoni. Despite the increasing focus on the use of praziquantel against schistosomiasis infections for the last three decades many areas in Sub-Saharan Africa still have high prevalences and intensities of schistosomiasis especially among school-age children. This is true for the area of Mwanza Region of Tanzania adjacent to Lake Victoria. The study is a six arm study and includes 150 communities (25 in each arm). From each community 100 school children (aged 9-12 years), 100 first year students (aged 7-8 years) and 50 adults (aged 20-55 years) are included, diagnosed and treated with praziquantel using strategies composing of a mixture of community wide treatment (CWT), school-based treatment (SBT) and years without treatment (-T). The 100 school children provided stool specimens on three consecutive days, while the 100 first year students and 50 adults with few exceptions only provided one specimen. The treatment strategies during the 4 years for the different arms are as follows: Arm 1: CWT, CWT, CWT, CWT; Arm 2: CWT, CWT, SBT, SBT; Arm 3: CWT, CWT -T, -T; Arm 4: SBT, SBT, SBT, SBT; Arm 5: SBT, SBT, -T, -T; Arm 6: SBT, -T, SBT, -T.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parasitologic Impact of Different Mass Drug Administration Strategies Against Schistosoma Mansoni in Endemic Areas of Mwanza Region, Tanzania, Where Prevalence is 25% or Above
Study Start Date : March 2011
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MDA once a year
Community wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg
Drug: Praziquantel
Six different treatment strategies with praziquantel
Other Name: no other drugs

Experimental: MDA 2nd year CWT follwed by 2 years SBT
Treatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT)
Drug: Praziquantel
Six different treatment strategies with praziquantel
Other Name: no other drugs

Experimental: Praziquantel every second year CWT
Treatment with praziquantel given every second year as CWT
Drug: Praziquantel
Six different treatment strategies with praziquantel
Other Name: no other drugs

Experimental: MDA once a year SBT
Treatment with praziquantel as above given as 4 years of SBT
Drug: Praziquantel
Six different treatment strategies with praziquantel
Other Name: no other drugs

Experimental: MDA given for 2 years as SBT
Treatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA
Drug: Praziquantel
Six different treatment strategies with praziquantel
Other Name: no other drugs

Experimental: MDA as SBT 1year and 1 year without MDA
Treatment with praziquantel given as one years of SBT alternating with one year without treatment
Drug: Praziquantel
Six different treatment strategies with praziquantel
Other Name: no other drugs




Primary Outcome Measures :
  1. Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults [ Time Frame: May -October 2016 (5 months) ]
    Prevalence and intensity of Schistosoma mansoni


Secondary Outcome Measures :
  1. Mass drug administration coverage [ Time Frame: May -October 2016 (5 months) ]
    Coverage of treatment


Other Outcome Measures:
  1. Cost of different treatment arm [ Time Frame: May-October 2016 (5 months) ]
    Cost of different treatment arm



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-All school children and adults who consent to participate can be included

Exclusion Criteria:

-Those not consenting or with any chronic disease not related to schistosomiasis will be excluded


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162875


Locations
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Tanzania
National Institute for Mediacal Research
Mwanza, Lake Region, Tanzania
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Investigators
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Principal Investigator: Safari Kinung'hi, PhD National Institute for Medical Research, Mwanza Research Centre
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Responsible Party: Pascal Magnussen, Associate Professor, DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier: NCT02162875    
Other Study ID Numbers: TAN-score
BMGF ( Other Grant/Funding Number: BMGF )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pascal Magnussen, DBL -Institute for Health Research and Development:
Schistosoma mansoni
treatment
school children
adults
Additional relevant MeSH terms:
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Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents