Uncomplicated Falciparum MalariaPhase 2NCT01407887
Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
A Phase 2 study testing artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) in people with Uncomplicated Falciparum Malaria, run by Heidelberg University at 1 site in Burkina Faso.
Trial summary
Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial. Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Phase: Phase II. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Uncomplicated Falciparum Malaria
- What is being tested?
- artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Aug 2011to Dec 2011
- 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
- 6-59 months old children (male and female)
- Weight ≥ 6kg
- Uncomplicated malaria caused by P. falciparum
- Asexual parasites ≥ 2 000/µl and ≤ 200 000/µl
- Axillary temperature ≥ 37.5°C or a history of fever during last 24 hours
- Burkinabe nationality
- Permanent residence in the study area with no intention of leaving during the surveillance period
- Informed consent
Who cannot join
- Severe malaria (WHO 2000)
- Vomiting (3 or more within 24 hours before the visit)
- Any apparent significant disease, including severe malnutrition
- A history of a previous, significant adverse reaction to either of the study drugs
- Anaemia (haemoglobin < 7 g/dl)
- Treated in the same trial before
Show all 9Show fewer
- All modern antimalarial treatment prior to inclusion (last seven days)
- Simultaneous participation in another investigational study
- Treatment with other investigational drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children
Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial.
Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso.
Read more
Phase: Phase II.
Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.
Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.
Sample size: 180 patients (90 per study arm).
- Conditions
- Uncomplicated Falciparum Malaria
- Being tested
- artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
- Keywords
- children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)Drug
The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.
| Study group | Role | What they receive |
|---|---|---|
| artesunate, amodiaquine methylene blue | Active comparator | two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ) Receives: Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) |
| artesunate amodiaquine | No intervention | The control group will receive once daily a fixed dose AS-AQ over three days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
P. falciparum gametocyte prevalence
- falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)
Measured: day 14 of follow-up
Secondary outcomes (1)
P. falciparum gametocyte prevalence and density
- falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (PCR determination) P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (microscopic determination)
Measured: day 1, 2, 3, 7, and 28 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated Falciparum 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Olaf Müller, Prof Dr, Principal investigator, Institut of Public health, University of heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407887
- Sponsor's protocol ID
- SFB544A8
- Status last verified
- Jun 2011
- First submitted
- 1 Aug 2011
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coulibaly B, Pritsch M, Bountogo M, Meissner PE, Nebie E, Klose C, Kieser M, Berens-Riha N, Wieser A, Sirima SB, Breitkreutz J, Schirmer RH, Sie A, Mockenhaupt FP, Drakeley C, Bousema T, Muller O. Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso. J Infect Dis. 2015 Mar 1;211(5):689-97. doi: 10.1093/infdis/jiu540. Epub 2014 Sep 28.
PubMed 25267980
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children
- ClinicalTrials.gov ID
- NCT01407887
- Acronym / sponsor ID
- SFB544A8
- Conditions
- Uncomplicated Falciparum Malaria
- Keywords
- children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Aug 2011 (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.
Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial.
Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso.
Phase: Phase II.
Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.
Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.
Sample size: 180 patients (90 per study arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artesunate, amodiaquine methylene blue | Active comparator | Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ) |
| artesunate amodiaquine | No intervention | –The control group will receive once daily a fixed dose AS-AQ over three days. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 6-59 months old children (male and female)
- Weight ≥ 6kg
- Uncomplicated malaria caused by P. falciparum
- Asexual parasites ≥ 2 000/µl and ≤ 200 000/µl
- Axillary temperature ≥ 37.5°C or a history of fever during last 24 hours
Key exclusion criteria (9 listed)
- Severe malaria (WHO 2000)
- Vomiting (3 or more within 24 hours before the visit)
- Any apparent significant disease, including severe malnutrition
- A history of a previous, significant adverse reaction to either of the study drugs
- Anaemia (haemoglobin < 7 g/dl)
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 |
|---|---|---|
| artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period. | Drug | artesunate, amodiaquine methylene blue |
Primary outcome
P. falciparum gametocyte prevalence
Time frame: day 14 of follow-up
P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)
1 secondary outcome
P. falciparum gametocyte prevalence and density
Time frame: day 1, 2, 3, 7, and 28 of follow-up
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 Dec 2012.
- Derived from this study: PubMed 25267980Coulibaly B, Pritsch M, Bountogo M, Meissner PE, Nebie E, Klose C, Kieser M, Berens-Riha N, Wieser A, Sirima SB, Breitkreutz J, Schirmer RH, Sie A, Mockenhaupt FP, Drakeley C, Bousema T, Muller O. Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso. J Infect Dis. 2015 Mar 1;211(5):689-97. doi: 10.1093/infdis/jiu540. Epub 2014 Sep 28.
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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.
Olaf Müller, Prof Dr principal investigator
Institut of Public health, University of heidelberg
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 artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) in people with Uncomplicated Falciparum 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 8 inclusion and 9 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 Dec 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 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?
P. falciparum gametocyte prevalence (time frame: day 14 of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407887, which also lists 1 linked publication.
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 Dec 2012.