MalariaPhase 4IPTi DRWGNCT00425763
Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum Malaria
A Phase 4 study testing AQAS in people with Malaria, run by Centers for Disease Control and Prevention at 1 site in Kenya.
Trial summary
We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria for each regimen. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- AQAS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteKenya
- Study dates
- May 2007to Aug 2007
- 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
- age 6-59 months
- axillary temperature ≥ 37.5º C, or history of fever in previous 24 hours
- weight ≥ 5.0 kg
- slide-confirmed infection with P. falciparum
- parasitemia 2000-200,000 asexual forms per μl
- ability and willingness to attend stipulated follow-up visits
Who cannot join
- signs or symptoms of severe disease
- weight-for-age ≤ 3rd percentile on Kenya growth charts
- slide confirmed infection with any other Plasmodium spp., besides falciparum
- severe anemia, defined as Hb < 7 g/dl
- known hypersensitivity to any of the drugs being tested
- enrolled in IPTi trial
- known chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Amodiaquine-artesunate in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children at an IPTi Site in Rural Western Kenya
We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria for each regimen.
Read the detailed description
We propose to conduct an amodiaquine-artesunate efficacy trial at Bondo District Hospital in Kenya. The results will enable us to better interpret the results of the main IPTi trial. We will assess the efficacy of a three day course of amodiaquine plus three days of artesunate (AQ3/AS3) for the treatment of symptomatic, uncomplicated P. falciparum infections. Study subjects are febrile children, 6-59 months old, with laboratory-confirmed uncomplicated P. falciparum infections. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Children will be followed closely for signs of drug failure or recrudescence, and any children failing therapy will be treated with Coartem or, if severe, with quinine. We will also perform drug resistance testing on parasite samples from children with treatment failure. The results of this efficacy trial will allow us to assist policymakers in deciding what drugs should be used for IPTi, should it be adopted into national policy.
- Conditions
- Malaria
- Being tested
- AQAS
- Keywords
- malaria, efficacy, intermittent preventive therapy in infants, drug resistance
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQASDrug
AQAS dosed by body weight, on days 0, 1, 2
| Study group | Role | What they receive |
|---|---|---|
| AQAS | Experimental | Not described Receives: Drug: AQAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological
Secondary outcomes (2)
Side effects
Molecular markers of drug resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2007
- Study completionAug 2007
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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute
- Investigators
- Meghna Desai, PhD, Principal investigator, Centers for Disease Control and PreventionMary Hamel, MD, Principal investigator, Centers for Disease Control and PreventionPatrick Kachur, MD, MPH, Study chair, Centers for Disease Control and PreventionRobert Newman, MD, MPH, Study chair, Centers for Disease Control and PreventionLarry Slutsker, MD, MPH, Study chair, Centers for Disease Control and PreventionJulie Thwing, MD, Study director, Centers for Disease Control and PreventionChristopher O Odero, Study director, CDC/KEMRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425763
- Sponsor's protocol ID
- CDC-NCID-5022
- Other IDs
- KEMRI-SSC-1190
- Acronym
- IPTi DRWG
- Status last verified
- Apr 2012
- First submitted
- 19 Jan 2007
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Amodiaquine-artesunate in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children at an IPTi Site in Rural Western Kenya
- ClinicalTrials.gov ID
- NCT00425763
- Acronym / sponsor ID
- IPTi DRWG / CDC-NCID-5022
- Conditions
- Malaria
- Keywords
- malaria, efficacy, intermittent preventive therapy in infants, drug resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute
- Study start
- May 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Jan 2007 (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.
We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria for each regimen.
Detailed description
We propose to conduct an amodiaquine-artesunate efficacy trial at Bondo District Hospital in Kenya. The results will enable us to better interpret the results of the main IPTi trial. We will assess the efficacy of a three day course of amodiaquine plus three days of artesunate (AQ3/AS3) for the treatment of symptomatic, uncomplicated P. falciparum infections. Study subjects are febrile children, 6-59 months old, with laboratory-confirmed uncomplicated P. falciparum infections. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Children will be followed closely for signs of drug failure or recrudescence, and any children failing therapy will be treated with Coartem or, if severe, with quinine. We will also perform drug resistance testing on parasite samples from children with treatment failure. The results of this efficacy trial will allow us to assist policymakers in deciding what drugs should be used for IPTi, should it be adopted into national policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AQAS | Experimental | Drug: AQAS |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- age 6-59 months
- axillary temperature ≥ 37.5º C, or history of fever in previous 24 hours
- weight ≥ 5.0 kg
- slide-confirmed infection with P. falciparum
- parasitemia 2000-200,000 asexual forms per μl
Key exclusion criteria (7 listed)
- signs or symptoms of severe disease
- weight-for-age ≤ 3rd percentile on Kenya growth charts
- slide confirmed infection with any other Plasmodium spp., besides falciparum
- severe anemia, defined as Hb < 7 g/dl
- known hypersensitivity to any of the drugs being tested
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 |
|---|---|---|
| AQASAQAS dosed by body weight, on days 0, 1, 2 | Drug | AQAS |
Primary outcome
28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological
2 secondary outcomes
Side effects
Molecular markers of drug resistance
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 5 Apr 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.
Meghna Desai, PhD principal investigator
Centers for Disease Control and Prevention
Mary Hamel, MD principal investigator
Centers for Disease Control and Prevention
Patrick Kachur, MD, MPH study chair
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AQAS in people with Malaria, run by Centers for Disease Control and Prevention at 1 site in Kenya.
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 6 inclusion and 7 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 5 Apr 2012. 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 Kenya. 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?
28 Day Adequate Clinical and Parasitological Response, Early Treatment Failure, Late Clinical Failure, Late Parasitological. 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 5 Apr 2012.