Plasmodium FalciparumPhase 3NCT00646126
Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission
A Phase 3 study testing Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS) in people with Plasmodium Falciparum and Asymptomatic Parataemia, run by Tropical Medicine Research Institute at 1 site in Sudan.
Trial summary
The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum, Asymptomatic Parataemia, Sub Patent Parasitaemia
- What is being tested?
- Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteSudan
- Study dates
- Aug 2005to not given
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All residents of the 8 villages
Who cannot join
- Pregnancy
- History of allergy to sulfa drugs
Trial locations and contacts
1 site in 1 country.
Sudan1 site
Tropical Medicine Research Institute
Khartoum, Khartoum State, 11111
About this study
Official title: Validation of the Use of Istope-Based Molecular Techniques for Malaria Control
The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. We are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern Sudan.
- Being tested
- Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS), placebo tablet similar to active drug in shape and size
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)Drug
Standard three day regimen
placebo tablet similar to active drug in shape and sizeDrug
Dosage similar to active drug(standard three days regimen)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1:Active comparator sulfadoxine-pyrimethamine plus artesunate Receives: Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS) |
| 2 | Placebo comparator | 2:placebo comparator Receives: Drug: placebo tablet similar to active drug in shape and size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages
Measured: October to December 2006
Secondary outcomes (1)
1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startAug 2005
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 Plasmodium FalciparumStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Tropical Medicine Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, International Atomic Energy Agency
- Investigators
- Badria B El Sayed, PhD,MSc,BSc, Principal investigator, Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646126
- Sponsor's protocol ID
- SUD 6/025
- Status last verified
- Aug 2005
- First submitted
- 25 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
PubMed 34585740
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Use of Istope-Based Molecular Techniques for Malaria Control
- ClinicalTrials.gov ID
- NCT00646126
- Acronym / sponsor ID
- SUD 6/025
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Tropical Medicine Research InstituteUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, International Atomic Energy Agency
- Study start
- Aug 2005
- First posted
- 28 Mar 2008 (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 malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. We are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern Sudan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)1:Active comparator sulfadoxine-pyrimethamine plus artesunate |
| 2 | Placebo comparator | Drug: placebo tablet similar to active drug in shape and size2:placebo comparator |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All residents of the 8 villages
Key exclusion criteria (2 listed)
- Pregnancy
- History of allergy to sulfa drugs
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 |
|---|---|---|
| Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)Standard three day regimen | Drug | 1 |
| placebo tablet similar to active drug in shape and sizeDosage similar to active drug(standard three days regimen) | Drug | 2 |
Primary outcome
Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages
Time frame: October to December 2006
1 secondary outcome
1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes
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 28 Mar 2008.
- Derived from this study: PubMed 34585740Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
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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.
Badria B El Sayed, PhD,MSc,BSc principal investigator
Tropical Medicine Research Institute
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 Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS) in people with Plasmodium Falciparum and Asymptomatic Parataemia, run by Tropical Medicine Research Institute 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 2 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 28 Mar 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 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. Some participants in this study may receive a placebo. 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?
Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages (time frame: October to December 2006). 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 NCT00646126, 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 28 Mar 2008.