Schistosoma MansoniSCORE_PARNCT02162875
Schistosoma Mansoni in Mwanza Region, Tanzania
A study testing Praziquantel in people with Schistosoma Mansoni, run by DBL -Institute for Health Research and Development at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 55 years
- Conditions the study is for
- Schistosoma Mansoni
- What is being tested?
- Praziquantel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37,500 participants
- Where
- 1 siteTanzania
- Study dates
- Mar 2011to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- -All school children and adults who consent to participate can be included
Who cannot join
- -Those not consenting or with any chronic disease not related to schistosomiasis will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Schistosoma Mansoni
- Being tested
- Praziquantel
- Keywords
- Schistosoma mansoni, treatment, school children, adults
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PraziquantelDrug
Also called no other drugs
Six different treatment strategies with praziquantel
| Study group | Role | What they receive |
|---|---|---|
| MDA once a year | Experimental | Community wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg Receives: Drug: Praziquantel |
| MDA 2nd year CWT follwed by 2 years SBT | Experimental | Treatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT) Receives: Drug: Praziquantel |
| Praziquantel every second year CWT | Experimental | Treatment with praziquantel given every second year as CWT Receives: Drug: Praziquantel |
| MDA once a year SBT | Experimental | Treatment with praziquantel as above given as 4 years of SBT Receives: Drug: Praziquantel |
| MDA given for 2 years as SBT | Experimental | Treatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA Receives: Drug: Praziquantel |
| MDA as SBT 1year and 1 year without MDA | Experimental | Treatment with praziquantel given as one years of SBT alternating with one year without treatment Receives: Drug: Praziquantel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults
Prevalence and intensity of Schistosoma mansoni
Measured: May -October 2016 (5 months)
Secondary outcomes (1)
Mass drug administration coverage
Coverage of treatment
Measured: May -October 2016 (5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startMar 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schistosoma MansoniStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Magnussen, DBL -Institute for Health Research and Development
- Investigators
- Safari Kinung'hi, PhD, Principal investigator, National Institute for Medical Research, Mwanza Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162875
- Sponsor's protocol ID
- TAN-score
- Other IDs
- BMGF
- Acronym
- SCORE_PAR
- Status last verified
- Feb 2017
- First submitted
- 26 May 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02162875
- Acronym / sponsor ID
- SCORE_PAR / TAN-score
- Conditions
- Schistosoma Mansoni
- Keywords
- Schistosoma mansoni, treatment, school children, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37,500 participants (estimated)
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MDA once a year | Experimental | Drug: PraziquantelCommunity wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg |
| MDA 2nd year CWT follwed by 2 years SBT | Experimental | Drug: PraziquantelTreatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT) |
| Praziquantel every second year CWT | Experimental | Drug: PraziquantelTreatment with praziquantel given every second year as CWT |
| MDA once a year SBT | Experimental | Drug: PraziquantelTreatment with praziquantel as above given as 4 years of SBT |
| MDA given for 2 years as SBT | Experimental | Drug: PraziquantelTreatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA |
| MDA as SBT 1year and 1 year without MDA | Experimental | Drug: PraziquantelTreatment with praziquantel given as one years of SBT alternating with one year without treatment |
Who may qualify
- Ages
- 7 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -All school children and adults who consent to participate can be included
Key exclusion criteria (1 listed)
- -Those not consenting or with any chronic disease not related to schistosomiasis will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PraziquantelAlso: no other drugsSix different treatment strategies with praziquantel | Drug | MDA 2nd year CWT follwed by 2 years SBT, MDA as SBT 1year and 1 year without MDA, MDA given for 2 years as SBT, MDA once a year, MDA once a year SBT, Praziquantel every second year CWT |
Primary outcome
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
1 secondary outcome
Mass drug administration coverage
Time frame: May -October 2016 (5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Schistosoma Mansoni
Not yet recruitingPhase 2/3
Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis
Schistosomiasis, Schistosoma Mansoni
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safari Kinung'hi, PhD principal investigator
National Institute for Medical Research, Mwanza Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Praziquantel in people with Schistosoma Mansoni, run by DBL -Institute for Health Research and Development at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults (time frame: May -October 2016 (5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.