Asymptomatic P.Falciparum MalariaPhase 3NCT00289250
Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum
A Phase 3 study testing Sulfadoxine-pyrimethamine and Sulfadoxine-pyrimethamine plus artesunate in people with Asymptomatic P.Falciparum Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic P.Falciparum Malaria
- What is being tested?
- Sulfadoxine-pyrimethamine and Sulfadoxine-pyrimethamine plus artesunate
- How many people
- 360 participants
- Where
- 1 siteThe Gambia
- Study dates
- May 2001to Dec 2001
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- P.falciparum parasitaemia above 20/uL
- Resident in one of the four study villages
Who cannot join
- Fever
- Any other sign of clinical malaria
- Pregnancy
- Weight <5kg
- History of hypersensitivity to any of the study drugs
- Treatment with any of the study drugs in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
The Gambia1 site
Medical Reseearch Council Laboratories The Gambia
Banjul, POBOX 273
About this study
Official title: Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial
Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.
Read the detailed description
Treatment of P. falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the density of gametocytes. Drug-induced release could enhance transmission of resistant parasites and would argue against the use of SP, especially for intermittent preventive treatment (IPT). We did a randomized trial to determine the effect of treatment with SP on gametocyte carriage. The trial is a three-arm open-label randomized trial. We randomized asymptomatic carriers of P.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. The trial was conducted during the dry (low malaria transmission) season in four rural villages in The Gambia. Adults and children aged over 6 months who had asexual P.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of SP, or SP plus a single dose of artesunate (SP+AS), or placebo. The primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.
- Conditions
- Asymptomatic P.Falciparum Malaria
- Being tested
- Sulfadoxine-pyrimethamine, Sulfadoxine-pyrimethamine plus artesunate
- Keywords
- Malaria, Gametocytes, Asymptomatic carriers
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of gametocytes 7 days after treatment
Secondary outcomes (2)
Presence of gametocytes 56 days after treatment
Asexual parasitaemia 14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startMay 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic P.Falciparum MalariaStudies 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
- None (open label)
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia
- Investigators
- Margaret Pinder, PhD, Study director, Medical Research Council Unit, The GambiaPaul J Milligan, PhD, Study chair, London School of Hygiene and Tropical MedicineSam K Dunyo, PhD, Principal investigator, Medical Research Council Unit, The Gambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289250
- Sponsor's protocol ID
- SCC867
- Status last verified
- Dec 2002
- First submitted
- 8 Feb 2006
- Last updated
- 1 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00289250
- Acronym / sponsor ID
- SCC867
- Conditions
- Asymptomatic P.Falciparum Malaria
- Keywords
- Malaria, Gametocytes, Asymptomatic carriers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia
- Study start
- May 2001
- Study completion
- Dec 2001
- First posted
- 9 Feb 2006 (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.
Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.
Detailed description
Treatment of P. falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the density of gametocytes. Drug-induced release could enhance transmission of resistant parasites and would argue against the use of SP, especially for intermittent preventive treatment (IPT). We did a randomized trial to determine the effect of treatment with SP on gametocyte carriage. The trial is a three-arm open-label randomized trial. We randomized asymptomatic carriers of P.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. The trial was conducted during the dry (low malaria transmission) season in four rural villages in The Gambia. Adults and children aged over 6 months who had asexual P.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of SP, or SP plus a single dose of artesunate (SP+AS), or placebo. The primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- P.falciparum parasitaemia above 20/uL
- Resident in one of the four study villages
Key exclusion criteria (6 listed)
- Fever
- Any other sign of clinical malaria
- Pregnancy
- Weight <5kg
- History of hypersensitivity to any of the study 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 | Drug | – |
| Sulfadoxine-pyrimethamine plus artesunate | Drug | – |
Primary outcome
Presence of gametocytes 7 days after treatment
2 secondary outcomes
Presence of gametocytes 56 days after treatment
Asexual parasitaemia 14 days after treatment
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 1 Mar 2006.
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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.
Margaret Pinder, PhD study director
Medical Research Council Unit, The Gambia
Paul J Milligan, PhD study chair
London School of Hygiene and Tropical Medicine
Sam K Dunyo, PhD principal investigator
Medical Research Council Unit, The Gambia
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 and Sulfadoxine-pyrimethamine plus artesunate in people with Asymptomatic P.Falciparum Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 2 inclusion and 6 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 1 Mar 2006. 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 The Gambia. 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?
Presence of gametocytes 7 days after treatment. 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 1 Mar 2006.