MalariaPhase 3NCT00118807
Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children
A Phase 3 study testing Amodiaquine plus artesunate (AQ/AS), Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) and Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ) in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Malaria
- What is being tested?
- Amodiaquine plus artesunate (AQ/AS), Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) and Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)
- How many people
- 1,800 participants
- Where
- 1 siteThe Gambia
- Study dates
- Aug 2003to Feb 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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presentation at health centre with febrile illness
- Monoinfection with P. falciparum
- Parasitaemia >=500/microlitre
- Fever or history of fever
Who cannot join
- Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul)
- Severe malnutrition
- Clinically evident concomitant disease
- PCV <20%
- History of allergy to the study medications
- Residence outside the study area and hence difficult to follow up
Trial locations and contacts
1 site in 1 country.
The Gambia1 site
Medical Research Council Laboratories
Banjul, City of Banjul, POBOX273
About this study
Official title: Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children
The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
Read the detailed description
Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.
- Conditions
- Malaria
- Being tested
- Amodiaquine plus artesunate (AQ/AS), Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ), Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)
- Keywords
- malaria treatment, artemisinin based combination therapy, Plasmodium falciparum, pragmatic trial, effectiveness
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amodiaquine plus artesunate (AQ/AS)Drug
Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)Drug
Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical failure by day 28
Incidence of adverse events
Secondary outcomes (7)
Compliance with treatment regimen
Parasitological failure by day 28
Clinical failure by day 14
Parasitological failure rate by day 14
Mean PCV on day 28
Gametocyte carriage rates
Transmissibility after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startAug 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,800 participants
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, National Malaria Control Programme, The Gambia
- Investigators
- Sam K Dunyo, PhD, Principal investigator, Medical Research CouncilPaul J Milligan, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118807
- Sponsor's protocol ID
- SCC940
- Other IDs
- MRC SCC No. 940
- Status last verified
- Jun 2003
- First submitted
- 1 Jul 2005
- Last updated
- 9 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children
- ClinicalTrials.gov ID
- NCT00118807
- Acronym / sponsor ID
- SCC940
- Conditions
- Malaria
- Keywords
- malaria treatment, artemisinin based combination therapy, Plasmodium falciparum, pragmatic trial, effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Medical Research Council, National Malaria Control Programme, The Gambia
- Study start
- Aug 2003
- Study completion
- Feb 2004
- First posted
- 12 Jul 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.
The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
Detailed description
Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Presentation at health centre with febrile illness
- Monoinfection with P. falciparum
- Parasitaemia >=500/microlitre
- Fever or history of fever
Key exclusion criteria (6 listed)
- Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul)
- Severe malnutrition
- Clinically evident concomitant disease
- PCV <20%
- History of allergy to the study medications
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 |
|---|---|---|
| Amodiaquine plus artesunate (AQ/AS) | Drug | – |
| Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) | Drug | – |
| Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ) | Drug | – |
Primary outcome
Clinical failure by day 28
Incidence of adverse events
7 secondary outcomes
Compliance with treatment regimen
Parasitological failure by day 28
Clinical failure by day 14
Parasitological failure rate by day 14
Mean PCV on day 28
Gametocyte carriage rates
Transmissibility 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 9 Jan 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.
Sam K Dunyo, PhD principal investigator
Medical Research Council
Paul J Milligan, PhD principal investigator
London School of Hygiene and Tropical Medicine
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 Amodiaquine plus artesunate (AQ/AS), Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) and Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ) in people with 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 4 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 9 Jan 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?
Clinical failure by day 28. The study lists 2 primary outcomes in all. 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 9 Jan 2006.