Intestinal SchistosomiasisPhase 2NCT01901484
Schistosoma Mansoni Morbidity in Children Aged 1-5 Years
A Phase 2 study testing Praziquantel in people with Intestinal Schistosomiasis, run by Makerere University at 1 site in Uganda.
Trial summary
This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged 1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the effects of the disease will be assessed.Children found positive with S. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Schistosomiasis
- What is being tested?
- Praziquantel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUganda
- Study dates
- Dec 2012to Feb 2014
- Phase
- Phase 2
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1-5 years
Who cannot join
- <1-5> years
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Child Health & Development Centre, College of Health Sciences , Makerere University
Kampala, 6717
About this study
Official title: Intestinal Schistosomiasis in Children Aged 1-5 Years,Morbidity Assessment and the Effect of Praziquantel on Morbidity; Along Lake Victoria Shorelines.
This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged 1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the effects of the disease will be assessed.Children found positive with S. mansoni will be treated with praziquantel and followed up for a year.
Read the detailed description
The study has three phases: in the first phase (Phase I) a baseline pretreatment schistosomiasis morbidity assessment of children aged 1-5 years will take place. The Kato-Katz technique will be used to detect and enumerate S. mansoni eggs in faecal samples from each participating child. Communities with the highest S. mansoni prevalence and intensity will be chosen and included in the study. In the second phase (Phase II) the S. mansoni positive children will be divided randomly into two intervention groups, single and double dose praziquantel treatment arms. Abdominal ultrasound will be combined with clinical examination to accurately identify hepatosplenomegaly. The sizes of both the liver and spleen will be examined. Anthropometric measurements and Hb for each child will also be recorded. In the last phase (Phase III), the effect of praziquantel on S. mansoni morbidity will be evaluated in all the treated children aged 1-5 years.
- Conditions
- Intestinal Schistosomiasis
- Being tested
- Praziquantel
- Keywords
- Schistosoma mansoni, morbidity, chemotherapy
- Medical subject headings
- Schistosomiasis mansoni, Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PraziquantelDrug
All the registered S. mansoni infected children aged 1-5 years will be randomly divided into two treatment arms: single and double dose. A second those will be administered after two weeks following the last treatment.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Praziquantel | Active comparator | Praziquantel 40mg/Kg - single dose Receives: Drug: Praziquantel |
| Praziquantel | Active comparator | double dose Receives: Drug: Praziquantel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of organomegaly at Day 0 and 8 months follow-up visits
Measured: 2 years
Secondary outcomes (1)
Cure rate at 30 days after treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Allen Nalugwa, Makerere University
- Investigators
- Allen Nalugwa, PhD, Principal investigator, CHDC-Makerere UniversityAnnette Olsen, PhD, Study director, University of CopenhagenEdridah Muheki, PhD, Study director, Ministry of Health, Vector Control DivisionFred Nuwaha, PhD, Study director, School of Public Health, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901484
- Sponsor's protocol ID
- 2012162
- Status last verified
- Sep 2014
- First submitted
- 30 May 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Schistosomiasis in Children Aged 1-5 Years,Morbidity Assessment and the Effect of Praziquantel on Morbidity; Along Lake Victoria Shorelines.
- ClinicalTrials.gov ID
- NCT01901484
- Acronym / sponsor ID
- 2012162
- Conditions
- Intestinal Schistosomiasis
- Keywords
- Schistosoma mansoni, morbidity, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Jul 2013 (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.
This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged 1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the effects of the disease will be assessed.Children found positive with S. mansoni will be treated with praziquantel and followed up for a year.
Detailed description
The study has three phases: in the first phase (Phase I) a baseline pretreatment schistosomiasis morbidity assessment of children aged 1-5 years will take place. The Kato-Katz technique will be used to detect and enumerate S. mansoni eggs in faecal samples from each participating child. Communities with the highest S. mansoni prevalence and intensity will be chosen and included in the study. In the second phase (Phase II) the S. mansoni positive children will be divided randomly into two intervention groups, single and double dose praziquantel treatment arms. Abdominal ultrasound will be combined with clinical examination to accurately identify hepatosplenomegaly. The sizes of both the liver and spleen will be examined. Anthropometric measurements and Hb for each child will also be recorded. In the last phase (Phase III), the effect of praziquantel on S. mansoni morbidity will be evaluated in all the treated children aged 1-5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Praziquantel | Active comparator | Drug: PraziquantelPraziquantel 40mg/Kg - single dose |
| Praziquantel | Active comparator | Drug: Praziquanteldouble dose |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1-5 years
Key exclusion criteria (1 listed)
- <1-5> years
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 |
|---|---|---|
| PraziquantelAll the registered S. mansoni infected children aged 1-5 years will be randomly divided into two treatment arms: single and double dose. A second those will be administered after two weeks following the last treatment. | Drug | Drug: Praziquantel, Praziquantel |
Primary outcome
Presence/absence of organomegaly at Day 0 and 8 months follow-up visits
Time frame: 2 years
1 secondary outcome
Cure rate at 30 days after treatment
Time frame: 2 years
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 17 Sep 2014.
Related trials for Intestinal Schistosomiasis
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Dengue, Chikungunya
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.
Allen Nalugwa, PhD principal investigator
CHDC-Makerere University
Annette Olsen, PhD study director
University of Copenhagen
Edridah Muheki, PhD study director
Ministry of Health, Vector Control Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Praziquantel in people with Intestinal Schistosomiasis, run by Makerere University 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 17 Sep 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Presence/absence of organomegaly at Day 0 and 8 months follow-up visits (time frame: 2 years). 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 17 Sep 2014.