MalariaPhase 2NCT00261222
Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
A Phase 2 study testing Amodiaquine in people with Malaria, run by Heidelberg University at 1 site in Burkina Faso.
Trial summary
Design: Single-centre Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN). Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Amodiaquine
- How many people
- 120 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Sep 2005to Nov 2005
- Phase
- Phase 2
- 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
- Uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C and ≥ 2.000 P. falciparum asexual parasites per µl blood)
- Written informed consent given by the parents/caretakers
Who cannot join
- Complicated or severe malaria (repeated vomiting, seizures or other neurological impairment, haemoglobin < 7 g/dl or haematocrit < 21%)
- Any apparent significant disease (e. g. pneumonia, meningitis, hepatitis, severe diarrhoea, measles, severe malnutrition)
- Malaria treatment with western drugs and/or antibiotics with anti malarial potency during last 7 days except chloroquine.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Centre de Recherche en Santé de Nouna (CRSN)
Nouna, P.O. Box 34
About this study
Design: Single-centre
Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN).
Read more
Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital outpatient department.
Sample size: N=120
Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three days (first and second day: 10mg/kg, third day: 5mg/kg).
Statistical procedures: The primary analysis parameter is the proportion of clinical failures on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without PCR correction), the rate of early clinical failures, the rate of late parasitological failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the overall group of study children and for rural (n=50) and urban (n=50) study children separately.
Study duration and dates: The study will be implemented in September-December 2005.
- Conditions
- Malaria
- Being tested
- Amodiaquine
- Keywords
- Amodiaquine, Efficacy, Malaria, Burkina Faso
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmodiaquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total clinical failure rate on day 14.
Clinical failure rate on day 14 in rural study area.
Clinical failure rate on day 14 in urban study area.
Secondary outcomes (11)
Total clinical failure rate on day 28.
Clinical failure rate on day 28 in rural study area.
Clinical failure rate on day 28 in urban study area.
Total early clinical failure rate.
Early clinical failure rate in rural study area.
Early clinical failure rate in urban study area.
Total late parasitological failure rate on day 14 and 28.
Late parasitological failure rate on day 14 and 28 in rural study area.
Late parasitological failure rate on day 14 and 28 in urban study area.
Incidence of observed and self-reported adverse events over the 28 days observation period
Monitoring of concomitant drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startSep 2005
- Study completionNov 2005
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso
- Investigators
- Germain Mandi, MD, Principal investigator, Centre de Recherche en Santé de NounaOlaf Mueller, MD, PhD, Study director, University of Heidelberg, Germany, Institute of Tropical Medecine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261222
- Sponsor's protocol ID
- SFB544-A8-AQ2005
- Status last verified
- Oct 2006
- First submitted
- 30 Nov 2005
- Last updated
- 3 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
- ClinicalTrials.gov ID
- NCT00261222
- Acronym / sponsor ID
- SFB544-A8-AQ2005
- Conditions
- Malaria
- Keywords
- Amodiaquine, Efficacy, Malaria, Burkina Faso
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso
- Study start
- Sep 2005
- Study completion
- Nov 2005
- First posted
- 2 Dec 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.
Design: Single-centre
Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN).
Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital outpatient department.
Sample size: N=120
Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three days (first and second day: 10mg/kg, third day: 5mg/kg).
Statistical procedures: The primary analysis parameter is the proportion of clinical failures on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without PCR correction), the rate of early clinical failures, the rate of late parasitological failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the overall group of study children and for rural (n=50) and urban (n=50) study children separately.
Study duration and dates: The study will be implemented in September-December 2005.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6-59 months
- Uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C and ≥ 2.000 P. falciparum asexual parasites per µl blood)
- Written informed consent given by the parents/caretakers
Key exclusion criteria (3 listed)
- Complicated or severe malaria (repeated vomiting, seizures or other neurological impairment, haemoglobin < 7 g/dl or haematocrit < 21%)
- Any apparent significant disease (e. g. pneumonia, meningitis, hepatitis, severe diarrhoea, measles, severe malnutrition)
- Malaria treatment with western drugs and/or antibiotics with anti malarial potency during last 7 days except chloroquine.
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 | Drug | – |
Primary outcome
Total clinical failure rate on day 14.
Clinical failure rate on day 14 in rural study area.
Clinical failure rate on day 14 in urban study area.
11 secondary outcomes
Total clinical failure rate on day 28.
Clinical failure rate on day 28 in rural study area.
Clinical failure rate on day 28 in urban study area.
Total early clinical failure rate.
Early clinical failure rate in rural study area.
Early clinical failure rate in urban study area.
Total late parasitological failure rate on day 14 and 28.
Late parasitological failure rate on day 14 and 28 in rural study area.
Late parasitological failure rate on day 14 and 28 in urban study area.
Incidence of observed and self-reported adverse events over the 28 days observation period
Monitoring of concomitant drug intake
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 3 Feb 2010.
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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.
Germain Mandi, MD principal investigator
Centre de Recherche en Santé de Nouna
Olaf Mueller, MD, PhD study director
University of Heidelberg, Germany, Institute of Tropical Medecine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amodiaquine in people with Malaria, run by Heidelberg University at 1 site in Burkina Faso.
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 3 inclusion and 3 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 3 Feb 2010. 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 Burkina Faso. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total clinical failure rate on day 14.. The study lists 3 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 3 Feb 2010.