Plasmodium InfectionsPhase 3NCT00330902
Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan
A Phase 3 study testing sulfadoxine-pyrimethamine (SP) plus artesunate (AS) and primaquine (PQ) plus SP+AS in people with Plasmodium Infections, run by London School of Hygiene and Tropical Medicine at 1 site in Sudan.
Trial summary
In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Infections
- What is being tested?
- sulfadoxine-pyrimethamine (SP) plus artesunate (AS) and primaquine (PQ) plus SP+AS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSudan
- Study dates
- Jan 2004to Nov 2004
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- infection with P.falciparum detected by PCR
Who cannot join
- pregnancy
- severe anaemia
- fever or other signs of illness
- history of allergy to sulfa drugs
- presence of other species of Plasmodium detected by microscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan
In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.
Read the detailed description
104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ), and were followed up for 14 days during the transmission-free season in Eastern Sudan. Subjects were visited on days 3, 7 and 14 after the start of treatment to record any adverse events and to detect P.falciparum using PCR. PCR positive samples were tested for gametocytes using RT-PCR. Packed cell volume was measured on days 7 and 14.
- Conditions
- Plasmodium Infections
- Being tested
- sulfadoxine-pyrimethamine (SP) plus artesunate (AS), primaquine (PQ) plus SP+AS
- Keywords
- malaria, subpatent parasitaemia, dry season, primaquine, Plasmodium falciparum infection detected by PCR
- Medical subject headings
- Malaria
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
sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
primaquine (PQ) plus SP+ASDrug
single dose of primaquine on day 4
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sulfadoxine pyrimethamine plus three daily doses of artesunate Receives: Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS) |
| 2 | Experimental | Sulfadoxine pyrimethamine plus artesunate plus primaquine Receives: Drug: primaquine (PQ) plus SP+AS |
What is being measured
The primary outcome is the main question the study is designed to answer.
P.falciparum parasitaemia detected by PCR on days 3,7 and 14.
Measured: 14 days from start of treatment
Secondary outcomes (2)
Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.
Measured: 14 days from start of treatment
Packed Cell volume on days 7 and 14.
Measured: Over 14 days from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startJan 2004
- Study completionNov 2004
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 InfectionsStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tropical Medicine Research Institute, World Health Organization
- Investigators
- Badria B El Sayed, PhD, Principal investigator, TMRI, KhartoumOmer Z Baraka, MD, Study chair, Faculty of Medicine, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330902
- Sponsor's protocol ID
- SGS64
- Status last verified
- Oct 2007
- First submitted
- 25 May 2006
- Last updated
- 31 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.
PubMed 18074034
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan
- ClinicalTrials.gov ID
- NCT00330902
- Acronym / sponsor ID
- SGS64
- Conditions
- Plasmodium Infections
- Keywords
- malaria, subpatent parasitaemia, dry season, primaquine, Plasmodium falciparum infection detected by PCR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Tropical Medicine Research Institute, World Health Organization
- Study start
- Jan 2004
- Study completion
- Nov 2004 (actual)
- First posted
- 29 May 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.
In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.
Detailed description
104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ), and were followed up for 14 days during the transmission-free season in Eastern Sudan. Subjects were visited on days 3, 7 and 14 after the start of treatment to record any adverse events and to detect P.falciparum using PCR. PCR positive samples were tested for gametocytes using RT-PCR. Packed cell volume was measured on days 7 and 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS)Sulfadoxine pyrimethamine plus three daily doses of artesunate |
| 2 | Experimental | Drug: primaquine (PQ) plus SP+ASSulfadoxine pyrimethamine plus artesunate plus primaquine |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- infection with P.falciparum detected by PCR
Key exclusion criteria (5 listed)
- pregnancy
- severe anaemia
- fever or other signs of illness
- history of allergy to sulfa drugs
- presence of other species of Plasmodium detected by microscopy
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)sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS) | Drug | 1 |
| primaquine (PQ) plus SP+ASsingle dose of primaquine on day 4 | Drug | 2 |
Primary outcome
P.falciparum parasitaemia detected by PCR on days 3,7 and 14.
Time frame: 14 days from start of treatment
2 secondary outcomes
Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.
Time frame: 14 days from start of treatment
Packed Cell volume on days 7 and 14.
Time frame: Over 14 days from start of 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 31 Oct 2007.
- Derived from this study: PubMed 18074034El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.
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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 principal investigator
TMRI, Khartoum
Omer Z Baraka, MD study chair
Faculty of Medicine, University of Khartoum
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) and primaquine (PQ) plus SP+AS in people with Plasmodium Infections, run by London School of Hygiene and Tropical Medicine 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 5 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 31 Oct 2007. 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?
P.falciparum parasitaemia detected by PCR on days 3,7 and 14. (time frame: 14 days from start of treatment). 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 NCT00330902, 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 31 Oct 2007.