MalariaPhase 2NCT00917202
Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso: Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8 Project of the SFB 544
A Phase 2 study testing Methylenblue in people with Malaria, run by Heidelberg University at 1 site in Burkina Faso.
Trial summary
Design: Single-centre, controlled study in adults with uncomplicated falciparum malaria in the Nouna Health District, north-western Burkina Faso Phase: Phase II Objectives: The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum… Read more about this study
- Who is it for?
- Ages 17 to 55 years, men only
- Conditions the study is for
- Malaria
- What is being tested?
- Methylenblue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteBurkina Faso
- Study dates
- Start not givento not given
- 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 17 to 55 years
- Men only
- Child, Adult
Who may be able to join
- Male adults (>17 years;<55 years)
- Uncomplicated malaria caused by P. falciparum
- Asexual parasites ≥ 1000/µl and ≤ 200 000/µl
- Axillary temperatures ≥ 37.5°C or history of fever during 48 hours
- Living in nouna Health District
- Informed consent
Who cannot join
- Complicated or severe malaria
- Any apparent significant disease
- Anaemia (haematocrit < 21%)
- Antimalarial treatment prior to inclusion (last three days)
- Increased creatinine blood levels
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso: Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8
Design: Single-centre, controlled study in adults with uncomplicated falciparum malaria in the Nouna Health District, north-western Burkina Faso
Phase: Phase II
Read more
Objectives: The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum malaria in an African area of high malaria transmission intensity.
Population: Male adults with uncomplicated malaria from Nouna town.
Sample size: N= 60 (n=20 for each group; three different dosing regimens of MB).
Treatment: The participants in the three different MB regimens will receive orally twice daily 390 mg MB (total daily dose 780mg) over 7,5 or 3 days respectively. Treatment with the five (three) day regimen will only start after all patients of the seven (five) days regimen have been followed up until day 3.
Endpoints: The primary endpoint is the adequate clinical and parasitological response (ACPR) rate on day 28. Secondary endpoints are the number of adverse events (AE) after drug intake until day 28, clinical and parasitological failure rates on day 14 and 28, changes in haemoglobin/haematocrit until day 28, and fever and parasite clearance time.
- Conditions
- Malaria
- Being tested
- Methylenblue
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylenblueDrug
| Study group | Role | What they receive |
|---|---|---|
| MB3 | Experimental | 3 days Receives: Drug: Methylenblue |
| MB5 | Experimental | 5 days Receives: Drug: Methylenblue |
| MB7 | Experimental | Not described Receives: Drug: Methylenblue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate clinical and parasitolgical response (ACPR) until D 28
Secondary outcomes (9)
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
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Incidence of serious adverse events over the 28 days observation period
MB whole blood concentrations (trough concentrations) on day 3,5 or 7 compared to trough concentrations after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917202
- Sponsor's protocol ID
- S-237/2007
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso: Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8
- ClinicalTrials.gov ID
- NCT00917202
- Acronym / sponsor ID
- S-237/2007
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- First posted
- 10 Jun 2009 (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, controlled study in adults with uncomplicated falciparum malaria in the Nouna Health District, north-western Burkina Faso
Phase: Phase II
Objectives: The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum malaria in an African area of high malaria transmission intensity.
Population: Male adults with uncomplicated malaria from Nouna town.
Sample size: N= 60 (n=20 for each group; three different dosing regimens of MB).
Treatment: The participants in the three different MB regimens will receive orally twice daily 390 mg MB (total daily dose 780mg) over 7,5 or 3 days respectively. Treatment with the five (three) day regimen will only start after all patients of the seven (five) days regimen have been followed up until day 3.
Endpoints: The primary endpoint is the adequate clinical and parasitological response (ACPR) rate on day 28. Secondary endpoints are the number of adverse events (AE) after drug intake until day 28, clinical and parasitological failure rates on day 14 and 28, changes in haemoglobin/haematocrit until day 28, and fever and parasite clearance time.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MB3 | Experimental | Drug: Methylenblue3 days |
| MB5 | Experimental | Drug: Methylenblue5 days |
| MB7 | Experimental | Drug: Methylenblue |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- Male only
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male adults (>17 years;<55 years)
- Uncomplicated malaria caused by P. falciparum
- Asexual parasites ≥ 1000/µl and ≤ 200 000/µl
- Axillary temperatures ≥ 37.5°C or history of fever during 48 hours
- Living in nouna Health District
Key exclusion criteria (5 listed)
- Complicated or severe malaria
- Any apparent significant disease
- Anaemia (haematocrit < 21%)
- Antimalarial treatment prior to inclusion (last three days)
- Increased creatinine blood levels
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 | Drug | MB3, MB5, MB7 |
Primary outcome
Adequate clinical and parasitolgical response (ACPR) until D 28
9 secondary outcomes
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
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Incidence of serious adverse events over the 28 days observation period
MB whole blood concentrations (trough concentrations) on day 3,5 or 7 compared to trough concentrations after the first dose
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 10 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 10 Jun 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?
Adequate clinical and parasitolgical response (ACPR) until D 28. 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 10 Jun 2009.