SchistosomiasisNCT00215267
The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda
A study testing praziquantel in people with Schistosomiasis and Malaria, run by DBL -Institute for Health Research and Development at 1 site in Uganda.
Trial summary
The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis, Malaria
- What is being tested?
- praziquantel
- How many people
- 540 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2005to Oct 2007
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- age > 7 years Residence in project village
Who cannot join
- persons treated with praziquantel within 2 weeks before recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of One Versus Two Praziquantel Treatments on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria in Uganda
The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control.
The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart.
Read the detailed description
In Uganda, schistosomiasis affects approximately 10% of the population and transmission takes place along all large water bodies (rivers and lakes).
Morbidity control should aim at increasing the length of time before morbidity reappears and decrease the time during which morbidity regresses in a situation with continued transmission and re-infection. It is proposed to test this by comparing the standard treatment with a double treatment (2 x 40 mg/kg) two weeks apart.
The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control.
The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart. Two groups of participants, with 270 people in each, will be randomly selected and randomly assigned to the two treatment regimens. Three consecutive stool samples will be from the cohort and blood samples for malaria will be examined. Clinical and ultrasonographic examinations will be performed. After all the examinations, the whole cohort will be treated with a single standard dose of praziquantel and albendazole. Two weeks later all members of one of the groups will receive another standard dose of praziquantel. Follow-up examinations will be performed 8 weeks, 6 months and two years later.
- Conditions
- Schistosomiasis, Malaria
- Being tested
- praziquantel
- Keywords
- Schistosoma mansoni, hepatosplenomegaly, malaria, Uganda
- Medical subject headings
- Schistosomiasis, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
praziquantelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rates
re-infection
pathology regression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DBL -Institute for Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Investigators
- Edridah M Tukahebwa, Msc, Principal investigator, Ministry of Health, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215267
- Sponsor's protocol ID
- HS02310105
- Status last verified
- Feb 2008
- First submitted
- 20 Sep 2005
- Last updated
- 21 Feb 2008
- Results posted
- No
Publications
Kildemoes AO, Vennervald BJ, Tukahebwa EM, Kabatereine NB, Magnussen P, de Dood CJ, Deelder AM, Wilson S, van Dam GJ. Rapid clearance of Schistosoma mansoni circulating cathodic antigen after treatment shown by urine strip tests in a Ugandan fishing community - Relevance for monitoring treatment efficacy and re-infection. PLoS Negl Trop Dis. 2017 Nov 13;11(11):e0006054. doi: 10.1371/journal.pntd.0006054. eCollection 2017 Nov.
PubMed 29131820Tukahebwa EM, Vennervald BJ, Nuwaha F, Kabatereine NB, Magnussen P. Comparative efficacy of one versus two doses of praziquantel on cure rate of Schistosoma mansoni infection and re-infection in Mayuge District, Uganda. Trans R Soc Trop Med Hyg. 2013 Jun;107(6):397-404. doi: 10.1093/trstmh/trt024. Epub 2013 Apr 17.
PubMed 23596262
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of One Versus Two Praziquantel Treatments on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria in Uganda
- ClinicalTrials.gov ID
- NCT00215267
- Acronym / sponsor ID
- HS02310105
- Conditions
- Schistosomiasis, Malaria
- Keywords
- Schistosoma mansoni, hepatosplenomegaly, malaria, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- DBL -Institute for Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- Ministry of Health, Uganda
- Study start
- Sep 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Sep 2005 (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 overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control.
The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart.
Detailed description
In Uganda, schistosomiasis affects approximately 10% of the population and transmission takes place along all large water bodies (rivers and lakes).
Morbidity control should aim at increasing the length of time before morbidity reappears and decrease the time during which morbidity regresses in a situation with continued transmission and re-infection. It is proposed to test this by comparing the standard treatment with a double treatment (2 x 40 mg/kg) two weeks apart.
The overall objective of the project is to contribute to an increased knowledge about the effect of praziquantel on schistosomiasis related morbidity and re-infection level among communities living along Lake Victoria in Mayuge district, Uganda with the overall aim of improving the strategies for morbidity control.
The study will be carried out in a high transmission area along Lake Victoria, in Mayuge district. It will be a randomised intervention study, comparing a single praziquantel treatment (40mg/kg) with two standard doses administered two weeks apart. Two groups of participants, with 270 people in each, will be randomly selected and randomly assigned to the two treatment regimens. Three consecutive stool samples will be from the cohort and blood samples for malaria will be examined. Clinical and ultrasonographic examinations will be performed. After all the examinations, the whole cohort will be treated with a single standard dose of praziquantel and albendazole. Two weeks later all members of one of the groups will receive another standard dose of praziquantel. Follow-up examinations will be performed 8 weeks, 6 months and two years later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- age > 7 years Residence in project village
Key exclusion criteria (1 listed)
- persons treated with praziquantel within 2 weeks before recruitment
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 |
|---|---|---|
| praziquantel | Drug | – |
Primary outcome
cure rates
re-infection
pathology regression
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 21 Feb 2008.
- Derived from this study: PubMed 29131820Kildemoes AO, Vennervald BJ, Tukahebwa EM, Kabatereine NB, Magnussen P, de Dood CJ, Deelder AM, Wilson S, van Dam GJ. Rapid clearance of Schistosoma mansoni circulating cathodic antigen after treatment shown by urine strip tests in a Ugandan fishing community - Relevance for monitoring treatment efficacy and re-infection. PLoS Negl Trop Dis. 2017 Nov 13;11(11):e0006054. doi: 10.1371/journal.pntd.0006054. eCollection 2017 Nov.
- Derived from this study: PubMed 23596262Tukahebwa EM, Vennervald BJ, Nuwaha F, Kabatereine NB, Magnussen P. Comparative efficacy of one versus two doses of praziquantel on cure rate of Schistosoma mansoni infection and re-infection in Mayuge District, Uganda. Trans R Soc Trop Med Hyg. 2013 Jun;107(6):397-404. doi: 10.1093/trstmh/trt024. Epub 2013 Apr 17.
- Related InfoLink provided by the sponsor.
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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.
Edridah M Tukahebwa, Msc principal investigator
Ministry of Health, Uganda
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 Schistosomiasis and Malaria, run by DBL -Institute for Health Research and Development at 1 site in Uganda.
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 21 Feb 2008. 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 Uganda. 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?
cure rates. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00215267, which also lists 2 linked publications.
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 21 Feb 2008.