MalariaPhase 2NCT00354380
Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study
A Phase 2 study testing Methylene blue, Artesunate and Amodiaquine in people with Malaria, run by Heidelberg University at 1 site in Burkina Faso.
Trial summary
The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Malaria
- What is being tested?
- Methylene blue, Artesunate and Amodiaquine
- How many people
- Not given
- Where
- 1 siteBurkina Faso
- Study dates
- Sep 2006to Nov 2006
- 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 10 years
- All sexes
- Child
Who may be able to join
- 6-10 year old children
- Ability to swallow tablets
- Uncomplicated malaria caused by P. falciparum
- Asexual parasites ≥ 2000/µl and < 200000/µl
- Axillary temperature ≥ 37.5°C
- Burkinabe nationality
- Informed consent
Who cannot join
- Complicated or severe malaria
- Any apparent significant disease
- Anaemia (haematocrit < 21%)
- Treated in the same trial before
- Antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.
Read the detailed description
Objectives: The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days AS-AQ regimen. Secondary objectives are to investigate the efficacy of MB-AS and MB-AQ.
Population: Children aged 6-10 years with uncomplicated malaria from Nouna town.
Sample size: N= 180 (n=60 for each group).
Treatment: The participants in the MB-AS group will receive orally twice daily 9mg/kg MB combined with once daily 4mg/kg AS over 3 days. The participants in the MB-AQ group will receive orally twice daily 9mg/kg MB combined with once daily 10mg/kg AQ over 3 days. The participants of the comparator group will receive a 3 day regimen of once daily oral AS (4mg/kg) combined with once daily AQ (10mg/kg).
Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until day 28. Secondary endpoints are the number of serious adverse events (SAE), adequate clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.
- Conditions
- Malaria
- Being tested
- Methylene blue, Artesunate, Amodiaquine
- Keywords
- Malaria, Africa, Methalyne-blue, Artesunate, Amodiaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blueDrug
ArtesunateDrug
AmodiaquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)
Secondary outcomes (8)
Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period
ACPR rate until D28
Early treatment failure (ETF) rate
Late clinical failure (LCF) rate at D14 and D28
Late parasitological failure (LPF) rate at D14 and D28
Fever clearance time
Parasite clearance time
Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startSep 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Olaf Mueller, MD, MPH, Principal investigator, Heidelberg UniversityPeter Meissner, MD, MSc Trop Paed, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354380
- Sponsor's protocol ID
- SFB544-A8-ASMB2006
- Status last verified
- Sep 2006
- First submitted
- 19 Jul 2006
- Last updated
- 24 Oct 2006
- Results posted
- No
Publications
Coulibaly B, Zoungrana A, Mockenhaupt FP, Schirmer RH, Klose C, Mansmann U, Meissner PE, Muller O. Strong gametocytocidal effect of methylene blue-based combination therapy against falciparum malaria: a randomised controlled trial. PLoS One. 2009;4(5):e5318. doi: 10.1371/journal.pone.0005318. Epub 2009 May 5.
PubMed 19415120Zoungrana A, Coulibaly B, Sie A, Walter-Sack I, Mockenhaupt FP, Kouyate B, Schirmer RH, Klose C, Mansmann U, Meissner P, Muller O. Safety and efficacy of methylene blue combined with artesunate or amodiaquine for uncomplicated falciparum malaria: a randomized controlled trial from Burkina Faso. PLoS One. 2008 Feb 20;3(2):e1630. doi: 10.1371/journal.pone.0001630.
PubMed 18286187
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study
- ClinicalTrials.gov ID
- NCT00354380
- Acronym / sponsor ID
- SFB544-A8-ASMB2006
- Conditions
- Malaria
- Keywords
- Malaria, Africa, Methalyne-blue, Artesunate, Amodiaquine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Nov 2006
- First posted
- 20 Jul 2006 (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.
The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.
Detailed description
Objectives: The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days AS-AQ regimen. Secondary objectives are to investigate the efficacy of MB-AS and MB-AQ.
Population: Children aged 6-10 years with uncomplicated malaria from Nouna town.
Sample size: N= 180 (n=60 for each group).
Treatment: The participants in the MB-AS group will receive orally twice daily 9mg/kg MB combined with once daily 4mg/kg AS over 3 days. The participants in the MB-AQ group will receive orally twice daily 9mg/kg MB combined with once daily 10mg/kg AQ over 3 days. The participants of the comparator group will receive a 3 day regimen of once daily oral AS (4mg/kg) combined with once daily AQ (10mg/kg).
Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until day 28. Secondary endpoints are the number of serious adverse events (SAE), adequate clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6-10 year old children
- Ability to swallow tablets
- Uncomplicated malaria caused by P. falciparum
- Asexual parasites ≥ 2000/µl and < 200000/µl
- Axillary temperature ≥ 37.5°C
Key exclusion criteria (5 listed)
- Complicated or severe malaria
- Any apparent significant disease
- Anaemia (haematocrit < 21%)
- Treated in the same trial before
- Antimalarial treatment prior to inclusion (last three days), except children having been treated with 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 |
|---|---|---|
| Methylene blue | Drug | – |
| Artesunate | Drug | – |
| Amodiaquine | Drug | – |
Primary outcome
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)
8 secondary outcomes
Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period
ACPR rate until D28
Early treatment failure (ETF) rate
Late clinical failure (LCF) rate at D14 and D28
Late parasitological failure (LPF) rate at D14 and D28
Fever clearance time
Parasite clearance time
Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline
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 24 Oct 2006.
- Derived from this study: PubMed 19415120Coulibaly B, Zoungrana A, Mockenhaupt FP, Schirmer RH, Klose C, Mansmann U, Meissner PE, Muller O. Strong gametocytocidal effect of methylene blue-based combination therapy against falciparum malaria: a randomised controlled trial. PLoS One. 2009;4(5):e5318. doi: 10.1371/journal.pone.0005318. Epub 2009 May 5.
- Derived from this study: PubMed 18286187Zoungrana A, Coulibaly B, Sie A, Walter-Sack I, Mockenhaupt FP, Kouyate B, Schirmer RH, Klose C, Mansmann U, Meissner P, Muller O. Safety and efficacy of methylene blue combined with artesunate or amodiaquine for uncomplicated falciparum malaria: a randomized controlled trial from Burkina Faso. PLoS One. 2008 Feb 20;3(2):e1630. doi: 10.1371/journal.pone.0001630.
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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 Mueller, MD, MPH principal investigator
Heidelberg University
Peter Meissner, MD, MSc Trop Paed principal investigator
Heidelberg University
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 Methylene blue, Artesunate and 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 7 inclusion and 5 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 24 Oct 2006. 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?
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11). 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 NCT00354380, which also lists 2 linked publications.
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 24 Oct 2006.