SchistosomiasisPhase 3NCT01558336
Schistosoma Haematobium Infections and Praziquantel
A Phase 3 study testing praziquantel in people with Schistosomiasis, run by University of Khartoum at 1 site in Sudan.
Trial summary
The purpose of this study is to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- praziquantel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteSudan
- Study dates
- Aug 2008to Sep 2012
- Phase
- Phase 3
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School children
Who cannot join
- Taking praziquantel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Schistosoma Haematobium Infections Among Schoolchildren in Central Sudan One Year After Treatment With Praziquantel
The purpose of this study is to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.
Read the detailed description
A longitudinal study will be conducted to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan. A cohort of schoolchildren (6-15 years of age) was investigated before and 1 year after treatment with a single dose of praziquantel 40mg/kg.
- Conditions
- Schistosomiasis
- Being tested
- praziquantel
- Keywords
- Schistosoma haematobium, schoolchildren, Central Sudan, Praziquantel
- Medical subject headings
- Schistosomiasis, Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
praziquantelDrug
praziquantel 40 mg/kg oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Praziguantel | Experimental | tablet single dose Receives: Drug: praziquantel |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
The reduction of the prevalence and intensity of S.haematobium infection following a single dose of praziquantel40mg/kg
Measured: one year
Secondary outcomes (1)
reduction in the intensity of infection by
will a single dose of PZQ significantly reduced intensity of infection of S. haematobium infection 1 year after treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startAug 2008
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- Hikma Pharmaceuticals LLC
- Responsible party
- Principal investigator, Ishag Adam, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558336
- Sponsor's protocol ID
- Schistosmiasis
- Status last verified
- Jan 2013
- First submitted
- 16 Mar 2012
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahmed AM, El Tash LA, Mohamed EY, Adam I. High levels of Schistosoma mansoni infections among schoolchildren in central Sudan one year after treatment with praziquantel. J Helminthol. 2012 Jun;86(2):228-32. doi: 10.1017/S0022149X11000290. Epub 2011 Jun 8.
PubMed 21729382
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schistosoma Haematobium Infections Among Schoolchildren in Central Sudan One Year After Treatment With Praziquantel
- ClinicalTrials.gov ID
- NCT01558336
- Acronym / sponsor ID
- Schistosmiasis
- Conditions
- Schistosomiasis
- Keywords
- Schistosoma haematobium, schoolchildren, Central Sudan, Praziquantel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- Hikma Pharmaceuticals LLC
- Study start
- Aug 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Mar 2012 (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 purpose of this study is to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan.
Detailed description
A longitudinal study will be conducted to evaluate the impact of praziquantel for the treatment of Schistosoma haematobium infection among schoolchildren in Al Salamania in Central Sudan. A cohort of schoolchildren (6-15 years of age) was investigated before and 1 year after treatment with a single dose of praziquantel 40mg/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Praziguantel | Experimental | Drug: praziquanteltablet single dose |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- School children
Key exclusion criteria (1 listed)
- Taking praziquantel
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 |
|---|---|---|
| praziquantelpraziquantel 40 mg/kg oral tablets | Drug | Praziguantel |
Primary outcome
cure rate
Time frame: one year
The reduction of the prevalence and intensity of S.haematobium infection following a single dose of praziquantel40mg/kg
1 secondary outcome
reduction in the intensity of infection by
Time frame: one year
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 Jan 2013.
- Results publication: PubMed 21729382Ahmed AM, El Tash LA, Mohamed EY, Adam I. High levels of Schistosoma mansoni infections among schoolchildren in central Sudan one year after treatment with praziquantel. J Helminthol. 2012 Jun;86(2):228-32. doi: 10.1017/S0022149X11000290. Epub 2011 Jun 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing praziquantel in people with Schistosomiasis, run by University of Khartoum at 1 site in Sudan.
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 Jan 2013. 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 Sudan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
cure rate (time frame: one year). 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 NCT01558336, which also lists 1 linked publication.
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 Jan 2013.