Malaria, FalciparumPhase 4NCT00164710
Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi
A Phase 4 study testing sulfadoxine-pyrimethamine, amodiaquine plus sulfadoxine-pyrimethamine and amodiaquine plus artesunate in people with Malaria, Falciparum, run by Centers for Disease Control and Prevention at 3 sites in Malawi.
Trial summary
Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- sulfadoxine-pyrimethamine, amodiaquine plus sulfadoxine-pyrimethamine and amodiaquine plus artesunate
- How many people
- 365 participants
- Where
- 3 sitesMalawi
- Study dates
- Apr 2005to Sep 2005
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 6 - 59 months
- Axillary temperature ≥ 37.5 °C
- Monoinfection with P. falciparum
- Parasitaemia between 2000 - 200000 parasites/µl
- Haemoglobin concentration (finger-prick blood sample by HemoCue) > 7g/dl
- Consent by the patient's adult guardian
- Residence in the locality and willingness to attend for scheduled visits
Who cannot join
- altered consciousness
- convulsions
- prostration (inability to sit/stand/suck/drink)
- respiratory distress or breathlessness
- jaundice
- abnormal breathing
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- haemoglobinuria
- circulatory collapse
- persistent vomiting (cannot keep down liquids)
- evidence of a diagnosis other than malaria on physical examination
- presence of mixed infection
- presence of severe malnutrition (as evidenced by symmetrical oedema involving at least the feet, light hair color, or cachexia)
- contraindications to the antimalarial drugs used, especially history of allergy
- history of receiving a drug with antimalarial activity in the week prior to enrollment
Trial locations and contacts
3 sites in 1 country.
Malawi3 sites
Matiki Health Center
Dwangwa, Nkhotakota District
Kawale Health Center
Lilongwe, Lilongwe District
Machinga District Hospital
Liwonde, Machinga District
About this study
Official title: An Open Randomised Trial of the Efficacy of Sulfadoxine-Pyrimethamine (SP), Amodiaquine + SP (AQ-SP), AQ + Artesunate (AQ-Art), Chlorproguanil-Dapsone + Art (CD-Art), and Lumefantrine-Artemether (LA) for Uncomplicated Malaria in Malawi
Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. This study was developed and conducted in collaboration with the National Malaria Control Programme of Malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the Malawian Ministry of Health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children under five years of age, four drug combinations, all of which are licensed in Malawi, are being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current data on its efficacy. Data on side effects of the drugs will also be collected. The results of this study will provide some of the information necessary to guide the Malawi National Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated malaria. The study adheres to the World Health Organization's 2003 standardized protocol for assessing antimalarial drug efficacy.
- Conditions
- Malaria, Falciparum
- Being tested
- sulfadoxine-pyrimethamine, amodiaquine plus sulfadoxine-pyrimethamine, amodiaquine plus artesunate, chlorproguanil-dapsone plus artesunate, lumefantrine-artemether
- Keywords
- antimalarials
- 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-pyrimethamineDrug
amodiaquine plus sulfadoxine-pyrimethamineDrug
amodiaquine plus artesunateDrug
chlorproguanil-dapsone plus artesunateDrug
lumefantrine-artemetherDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
• Rate of Adequate Clinical and Parasitological Response at 14 days (WHO-defined measure of efficacy)
Secondary outcomes (12)
• Rate of Adequate clinical and parasitological response 28 days
• Mean percent change in blood haemoglobin concentration between day 0 and day 28
• Incidence of adverse events during the period of observation
• Rate of Early Treatment Failure (as defined by the WHO in their 2003 standardized protocol for assessing antimalarial drug efficacy)
• Rate of Late Clinical Failure (as defined by the WHO)
• Rate of Late Parasitologic Failure (as defined by the WHO)
• Percent of patients with a decrease in haemoglobin concentration
• Percent of patients with a decrease in haemoglobin concentration of ≥ 2g/dl
• Prevalence of parasitemia on Day 2
• Prevalence of parasitemia on Day 3
• Gametocyte prevalence on Day 14
• Gametocyte prevalence on Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 365 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ministry of Health, Malawi
- Responsible party
- Sponsor
- Investigators
- Rachel N Bronzan, MD, MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164710
- Sponsor's protocol ID
- CDC-NCID-4539
- Other IDs
- PA# 04018
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 27 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomised Trial of the Efficacy of Sulfadoxine-Pyrimethamine (SP), Amodiaquine + SP (AQ-SP), AQ + Artesunate (AQ-Art), Chlorproguanil-Dapsone + Art (CD-Art), and Lumefantrine-Artemether (LA) for Uncomplicated Malaria in Malawi
- ClinicalTrials.gov ID
- NCT00164710
- Acronym / sponsor ID
- CDC-NCID-4539
- Conditions
- Malaria, Falciparum
- Keywords
- antimalarials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ministry of Health, Malawi
- Study start
- Apr 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 14 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.
Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. This study was developed and conducted in collaboration with the National Malaria Control Programme of Malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the Malawian Ministry of Health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children under five years of age, four drug combinations, all of which are licensed in Malawi, are being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current data on its efficacy. Data on side effects of the drugs will also be collected. The results of this study will provide some of the information necessary to guide the Malawi National Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated malaria. The study adheres to the World Health Organization's 2003 standardized protocol for assessing antimalarial drug efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children age 6 - 59 months
- Axillary temperature ≥ 37.5 °C
- Monoinfection with P. falciparum
- Parasitaemia between 2000 - 200000 parasites/µl
- Haemoglobin concentration (finger-prick blood sample by HemoCue) > 7g/dl
Key exclusion criteria (14 listed)
- altered consciousness
- convulsions
- prostration (inability to sit/stand/suck/drink)
- respiratory distress or breathlessness
- jaundice
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 | – |
| amodiaquine plus sulfadoxine-pyrimethamine | Drug | – |
| amodiaquine plus artesunate | Drug | – |
| chlorproguanil-dapsone plus artesunate | Drug | – |
| lumefantrine-artemether | Drug | – |
Primary outcome
• Rate of Adequate Clinical and Parasitological Response at 14 days (WHO-defined measure of efficacy)
12 secondary outcomes
• Rate of Adequate clinical and parasitological response 28 days
• Mean percent change in blood haemoglobin concentration between day 0 and day 28
• Incidence of adverse events during the period of observation
• Rate of Early Treatment Failure (as defined by the WHO in their 2003 standardized protocol for assessing antimalarial drug efficacy)
• Rate of Late Clinical Failure (as defined by the WHO)
• Rate of Late Parasitologic Failure (as defined by the WHO)
• Percent of patients with a decrease in haemoglobin concentration
• Percent of patients with a decrease in haemoglobin concentration of ≥ 2g/dl
• Prevalence of parasitemia on Day 2
• Prevalence of parasitemia on Day 3
• Gametocyte prevalence on Day 14
• Gametocyte prevalence on Day 28
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 27 Sep 2012.
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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.
Rachel N Bronzan, MD, MPH principal investigator
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, amodiaquine plus sulfadoxine-pyrimethamine and amodiaquine plus artesunate in people with Malaria, Falciparum, run by Centers for Disease Control and Prevention at 3 sites in Malawi.
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 7 inclusion and 14 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 27 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 Malawi. 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?
• Rate of Adequate Clinical and Parasitological Response at 14 days (WHO-defined measure of efficacy). 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 27 Sep 2012.