MalariaPhase 2NCT00545935
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso
A Phase 2 study testing Methylenblue-Amodiaquine (MB-AQ), Methylenblue-Artesunate (MB-AS) and Artesunate-Amodiaquine (AS-AQ) in people with Malaria, run by Heidelberg University at 1 site in Burkina Faso.
Trial summary
The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Methylenblue-Amodiaquine (MB-AQ), Methylenblue-Artesunate (MB-AS) and Artesunate-Amodiaquine (AS-AQ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jul 2007to Oct 2007
- 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
- Child
Who may be able to join
- 0.5-5 year (6-59 months) old children
- uncomplicated malaria caused by P. falciparum
- asexual parasites ≥ 2000/µ and ≤ 200000/µ
- axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
- Burkinabe nationality
- informed consent
Who cannot join
- complicated or severe malaria
- any apparent significant disease
- anaemia (haematocrit < 21%)
- treated in the same trial before
- modern 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
Official title: Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544
The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.
- Conditions
- Malaria
- Being tested
- Methylenblue-Amodiaquine (MB-AQ), Methylenblue-Artesunate (MB-AS), Artesunate-Amodiaquine (AS-AQ)
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylenblue-Amodiaquine (MB-AQ)Drug
For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
Methylenblue-Artesunate (MB-AS)Drug
3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
Artesunate-Amodiaquine (AS-AQ)Drug
For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.
| Study group | Role | What they receive |
|---|---|---|
| 1-Methylenblue-Amodiaquine | Active comparator | Not described Receives: Drug: Methylenblue-Amodiaquine (MB-AQ) |
| 2-Methylenblue-Artesunate | Active comparator | Not described Receives: Drug: Methylenblue-Artesunate (MB-AS) |
| 3-Artesunate-Amodiaquine | Active comparator | Not described Receives: Drug: Artesunate-Amodiaquine (AS-AQ) |
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
Measured: 28 days
Secondary outcomes (8)
Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)
Measured: 28 days
Early treatment failure (ETF) rate
Measured: 28 days
Late clinical failure (LCF) rate at D14 and D28
Measured: 28 days
Late parasitological failure (LPF) rate at D14 and D28
Measured: 28 days
Fever clearance time
Measured: 28 days
Parasite clearance time
Measured: 28 days
Change in haematocrit after 2,14 and 28 days compared to baseline
Measured: 28 days
MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startJul 2007
- Study completionOct 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Olaf Mueller, Prof., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545935
- Sponsor's protocol ID
- MB-2007b
- Status last verified
- Feb 2009
- First submitted
- 16 Oct 2007
- Last updated
- 3 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544
- ClinicalTrials.gov ID
- NCT00545935
- Acronym / sponsor ID
- MB-2007b
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- Oct 2007
- First posted
- 17 Oct 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.
The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-Methylenblue-Amodiaquine | Active comparator | Drug: Methylenblue-Amodiaquine (MB-AQ) |
| 2-Methylenblue-Artesunate | Active comparator | Drug: Methylenblue-Artesunate (MB-AS) |
| 3-Artesunate-Amodiaquine | Active comparator | Drug: Artesunate-Amodiaquine (AS-AQ) |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (6 listed)
- 0.5-5 year (6-59 months) old children
- uncomplicated malaria caused by P. falciparum
- asexual parasites ≥ 2000/µ and ≤ 200000/µ
- axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
- Burkinabe nationality
Key exclusion criteria (5 listed)
- complicated or severe malaria
- any apparent significant disease
- anaemia (haematocrit < 21%)
- treated in the same trial before
- modern 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 |
|---|---|---|
| Methylenblue-Amodiaquine (MB-AQ)For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ | Drug | 1-Methylenblue-Amodiaquine |
| Methylenblue-Artesunate (MB-AS)3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days | Drug | 2-Methylenblue-Artesunate |
| Artesunate-Amodiaquine (AS-AQ)For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS. | Drug | 3-Artesunate-Amodiaquine |
Primary outcome
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Time frame: 28 days
8 secondary outcomes
Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)
Time frame: 28 days
Early treatment failure (ETF) rate
Time frame: 28 days
Late clinical failure (LCF) rate at D14 and D28
Time frame: 28 days
Late parasitological failure (LPF) rate at D14 and D28
Time frame: 28 days
Fever clearance time
Time frame: 28 days
Parasite clearance time
Time frame: 28 days
Change in haematocrit after 2,14 and 28 days compared to baseline
Time frame: 28 days
MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose
Time frame: 28 days
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 2009.
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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, Prof. 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 Methylenblue-Amodiaquine (MB-AQ), Methylenblue-Artesunate (MB-AS) and Artesunate-Amodiaquine (AS-AQ) 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 6 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 3 Feb 2009. 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 (time frame: 28 days). 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 2009.