Malaria, FalciparumPhase 4NCT00164359
Amodiaquine Plus Artesunate Versus Lapdap Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi
A Phase 4 study testing Amodiaquine plus artesunate and chlorproguanil-dapsone plus artesunate in people with Malaria, Falciparum, run by Centers for Disease Control and Prevention at 3 sites in Malawi.
Trial summary
Sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to an imminent need for the government of Malawi to identify a new first-line therapy for uncomplicated malaria and to implement that new… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Amodiaquine plus artesunate and chlorproguanil-dapsone plus artesunate
- How many people
- 212 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age five years or older
- Axillary temperature >= 37.5 degrees Celsius
- Monoinfection with P. falciparum
- Parasitemia between 2000 and 200000 parasites/microliter
- Hemoglobin concentration >= 7g/dl
- Consent by the patient of patient's adult guardian
- Residence in the locality and willingness to attend for scheduled visits
- Negative urine pregnancy test in women age twelve years and older
Who cannot join
- Signs of severe or complicated malaria
- altered consciousness
- convulsions
- prostration (inability to sit/stand/suck/drink)
- respiratory distress or breathlessness
- jaundice
Show all 15Show fewer
- abnormal breathing
- hemoglobinuria
- 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 edema 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: A Double-blind Randomised Trial to Assess the Tolerability of Amodiaquine Plus Artesunate (AQ-Art) Versus Chlorproguanil Plus Dapsone Plus Artesunate (CDA) in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi
Sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to an imminent need for the government of Malawi to identify a new first-line therapy for uncomplicated malaria and to implement that new therapy as policy. This protocol is the second of two protocols whose combined purpose is to provide efficacy and side effect data on four antimalarial drug combinations that are candidates for the next first-line therapy for uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry in 1995 because of a perceived association with abdominal pain. Although no studies were conducted to substantiate this, consensus among clinicians was that patients were refusing amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was removed from the registry. Results from this study, along with the efficacy data from the sister protocol in children under five years of age, will help guide the National Malaria Control Program of Malawi in selecting their next first-line antimalarial therapy.
- Conditions
- Malaria, Falciparum
- Being tested
- Amodiaquine plus artesunate, chlorproguanil-dapsone plus artesunate
- Keywords
- malaria, falciparum, 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.
Amodiaquine plus artesunateDrug
chlorproguanil-dapsone plus artesunateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of abdominal pain on days 1, 2, and 3 in the two treatment groups
Secondary outcomes (13)
Rate of adequate clinical and parasitological response at 14 days
Rate of adequate clinical and parasitological response at 28 days
Mean percent change in blood haemoglobin concentration between day 0 and day 28
Incidence of adverse events other than abdominal pain during the period of observation
Rate of Early Treatment Failure (per WHO definition)
Rate of Late Clinical Failure (per WHO definition)
Rate of Late Parasitological Failure (per WHO definition)
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
- Double blind
- Enrolment
- 212 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
- NCT00164359
- Sponsor's protocol ID
- CDC-NCID-4538
- Other IDs
- PA#04018
- Status last verified
- Sep 2012
- First submitted
- 9 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
- A Double-blind Randomised Trial to Assess the Tolerability of Amodiaquine Plus Artesunate (AQ-Art) Versus Chlorproguanil Plus Dapsone Plus Artesunate (CDA) in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi
- ClinicalTrials.gov ID
- NCT00164359
- Acronym / sponsor ID
- CDC-NCID-4538
- Conditions
- Malaria, Falciparum
- Keywords
- malaria, falciparum, antimalarials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 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 is the current first-line therapy for uncomplicated malaria in Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to an imminent need for the government of Malawi to identify a new first-line therapy for uncomplicated malaria and to implement that new therapy as policy. This protocol is the second of two protocols whose combined purpose is to provide efficacy and side effect data on four antimalarial drug combinations that are candidates for the next first-line therapy for uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry in 1995 because of a perceived association with abdominal pain. Although no studies were conducted to substantiate this, consensus among clinicians was that patients were refusing amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was removed from the registry. Results from this study, along with the efficacy data from the sister protocol in children under five years of age, will help guide the National Malaria Control Program of Malawi in selecting their next first-line antimalarial therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age five years or older
- Axillary temperature >= 37.5 degrees Celsius
- Monoinfection with P. falciparum
- Parasitemia between 2000 and 200000 parasites/microliter
- Hemoglobin concentration >= 7g/dl
Key exclusion criteria (15 listed)
- Signs of severe or complicated malaria
- altered consciousness
- convulsions
- prostration (inability to sit/stand/suck/drink)
- respiratory distress or breathlessness
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 | Drug | – |
| chlorproguanil-dapsone plus artesunate | Drug | – |
Primary outcome
Incidence of abdominal pain on days 1, 2, and 3 in the two treatment groups
13 secondary outcomes
Rate of adequate clinical and parasitological response at 14 days
Rate of adequate clinical and parasitological response at 28 days
Mean percent change in blood haemoglobin concentration between day 0 and day 28
Incidence of adverse events other than abdominal pain during the period of observation
Rate of Early Treatment Failure (per WHO definition)
Rate of Late Clinical Failure (per WHO definition)
Rate of Late Parasitological Failure (per WHO definition)
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 Amodiaquine plus artesunate and chlorproguanil-dapsone 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 8 inclusion and 15 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?
Incidence of abdominal pain on days 1, 2, and 3 in the two treatment groups. 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.