Malaria (Uncomplicated)Phase 4NCT00140361
Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria
A Phase 4 study testing Sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artesunate and lumefantrine plus artemether in people with Malaria (Uncomplicated), run by Centers for Disease Control and Prevention at 3 sites in Tanzania.
Trial summary
This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria (Uncomplicated)
- What is being tested?
- Sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artesunate and lumefantrine plus artemether
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 390 participants
- Where
- 3 sitesTanzania
- Study dates
- Jan 2000to Jan 2008
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children < 5 years of age (in one site, patients of all ages are eligible).
- Documented fever (axillary temperature >= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition
- Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3
- Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study
Who cannot join
- Any evidence of severe malaria that would require hospitalization for treatment.
- Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs.
- History of pregnancy or delayed menstrual period
- Breastfeeding a child less than 8 weeks of age
Trial locations and contacts
3 sites in 1 country.
Tanzania3 sites
Ikwiriri Health Center
Ikwiriri, Rufiji
Lupiro Health Center
Lupiro, Ulanga
Ngere Ngere Health Center
Ngerengere, Morogoro Rural
About this study
Official title: Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children
This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.
Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection
Read the detailed description
This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.
Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection
- Conditions
- Malaria (Uncomplicated)
- Being tested
- Sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artesunate, lumefantrine plus artemether, Sleeping under insecticide-treated bednet
- Keywords
- malaria, sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artsunate, lumefantrine plus artemether, combination therapy
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine-pyrimethamineDrug
sulfadoxine-pyrimethamine plus artesunateDrug
lumefantrine plus artemetherDrug
Sleeping under insecticide-treated bednetBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and parasitologic failure rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJan 2000
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria (Uncomplicated)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Peter B Bloland, DVM, MPVM, Principal investigator, Centers for Disease Control and PreventionSalim Abdulla, MD, PhD, Study director, Ifakara Health Research and Development CentreJohn R MacArthur, MD, MPH, Study director, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140361
- Sponsor's protocol ID
- CDC-NCID-2577
- Other IDs
- UR3/CCU018969-01
- Status last verified
- Sep 2012
- First submitted
- 30 Aug 2005
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children
- ClinicalTrials.gov ID
- NCT00140361
- Acronym / sponsor ID
- CDC-NCID-2577
- Conditions
- Malaria (Uncomplicated)
- Keywords
- malaria, sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artsunate, lumefantrine plus artemether, combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Jan 2000
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 1 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.
This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.
Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection
Detailed description
This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania.
Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Children < 5 years of age (in one site, patients of all ages are eligible).
- Documented fever (axillary temperature >= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition
- Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3
- Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study
Key exclusion criteria (4 listed)
- Any evidence of severe malaria that would require hospitalization for treatment.
- Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs.
- History of pregnancy or delayed menstrual period
- Breastfeeding a child less than 8 weeks of age
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 | Drug | – |
| sulfadoxine-pyrimethamine plus artesunate | Drug | – |
| lumefantrine plus artemether | Drug | – |
| Sleeping under insecticide-treated bednet | Behavioural | – |
Primary outcome
Clinical and parasitologic failure rate
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 11 Sep 2012.
- Website for major collaborating institution in TanzaniaLink 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.
Peter B Bloland, DVM, MPVM principal investigator
Centers for Disease Control and Prevention
Salim Abdulla, MD, PhD study director
Ifakara Health Research and Development Centre
John R MacArthur, MD, MPH study director
Centers for Disease Control and Prevention
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfadoxine-pyrimethamine, sulfadoxine-pyrimethamine plus artesunate and lumefantrine plus artemether in people with Malaria (Uncomplicated), run by Centers for Disease Control and Prevention at 3 sites 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 4 inclusion and 4 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 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Clinical and parasitologic failure rate. 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 11 Sep 2012.